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Sikkim University: Rules & Syllabus For The Bachelor of Pharmacy (B. Pharm) Course

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0% found this document useful (0 votes)
188 views147 pages

Sikkim University: Rules & Syllabus For The Bachelor of Pharmacy (B. Pharm) Course

Uploaded by

Vikash Kushwaha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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SIKKIM UNIVERSITY

Rules & Syllabus for the Bachelor of


Pharmacy (B. Pharm) Course

B. Pharm
(1st – 8th Semester)

[Framed under Regulation 6, 7 & 8 of the Bachelor of


Pharmacy (B. Pharm) Course Regulations 2014]
Pharmacy Council of India
New Delhi
(Based on Notification in the Gazette of India No-362, dated 11.12.2014)

2017
Course of study
The course of study for B. Pharm shall include Semester Wise Theory & Practical
as given in Table – I to VIII. The number of hours to be devoted to each theory, tutorial
and practical course in any semester shall not be less than that shown in Table – I to VIII.

Table-I: Course of study for semester I


Course code No. of Tuto Credit
Name of the course
hours rial points
BP101T Human Anatomy and Physiology I–
3 1 4
Theory
BP102T Pharmaceutical Analysis I – Theory 3 1 4
BP103T Pharmaceutics I – Theory 3 1 4
BP104T Pharmaceutical Inorganic Chemistry –
3 1 4
Theory
BP105RBT Remedial Biology/
2/3 - 2/3
BP105RMT Remedial Mathematics – Theory
BP106P Human Anatomy and Physiology –
4 - 2
Practical
BP107P Pharmaceutical Analysis I – Practical 4 - 2
BP108P Pharmaceutics I – Practical 4 - 2
BP109P Pharmaceutical Inorganic Chemistry –
4 - 2
Practical
BP110RBP Remedial Biology – Practical 2 - 1
Total 31$ /32# 4 27
$
Applicable ONLY for the students who have studied Physics / Chemistry / Botany / Zoology at HSC
and appearing for Remedial Mathematics (RM)course.
#
Applicable ONLY for the students who have studied Mathematics / Physics / Chemistry at HSC and
appearing for Remedial Biology (RB)course.

Table-II: Course of study for semester II

Course No. of Credit


Name of the course Tutorial
Code hours points
BP201T Human Anatomy and Physiology II – Theory 3 1 4
BP202T Pharmaceutical Organic Chemistry I – Theory 3 1 4
BP203T Biochemistry – Theory 3 1 4
BP204T Pathophysiology – Theory 3 1 4
BP205T Computer Applications in Pharmacy – Theory 3 - 3
BP206P Human Anatomy and Physiology II –Practical 4 - 2
BP207P Pharmaceutical Organic Chemistry I– Practical 4 - 2
BP208P Biochemistry – Practical 4 - 2
BP209P Computer Applications in Pharmacy – Practical 2 - 1
Total 29 4 26
Table-III: Course of study for semester III

Course No. of Credit


Name of the course Tutorial
code hours points
BP301T Pharmaceutical Organic Chemistry II – Theory 3 1 4
BP302T Physical Pharmaceutics I – Theory 3 1 4
BP303T Pharmaceutical Microbiology – Theory 3 1 4
BP304T Pharmaceutical Engineering – Theory 3 1 4
BP305P Pharmaceutical Organic Chemistry II – Practical 4 - 2
BP306P Physical Pharmaceutics I – Practical 4 - 2
BP307P Pharmaceutical Microbiology – Practical 4 - 2
BP 308P Pharmaceutical Engineering –Practical 4 - 2
Total 28 4 24

Table-IV: Course of study for semester IV

Course No. of Credit


Name of the course Tutorial
code hours points
BP401T Pharmaceutical Organic Chemistry III– Theory 3 1 4
BP402T Medicinal Chemistry I – Theory 3 1 4
BP403T Physical Pharmaceutics II – Theory 3 1 4
BP404T Pharmacology I – Theory 3 1 4
BP405T Pharmacognosy and Phytochemistry I– Theory 3 1 4
BP406T Communicative English 3 1 4
BP407P Medicinal Chemistry I – Practical 4 - 2
BP408P Physical Pharmaceutics II – Practical 4 2
BP409P Pharmacology I – Practical 4 - 2
BP410P Pharmacognosy and Phytochemistry I – Practical 4 - 2
Total 34 6 32
Table-V: Course of study for semester V

Course No. of Credit


Name of the course Tutorial
code hours points
BP501T Medicinal Chemistry II – Theory 3 1 4
BP502T Industrial PharmacyI– Theory 3 1 4
BP503T Pharmacology II – Theory 3 1 4
BP504T Pharmacognosy and Phytochemistry II– Theory 3 1 4
BP505T Pharmaceutical Jurisprudence – Theory 3 1 4
BP506T Environmental Studies 3 1 4
BP507P Industrial Pharmacy I – Practical 4 - 2
BP508P Pharmacology II – Practical 4 - 2
BP509P Pharmacognosy and Phytochemistry II – 4 - 2
Practical
Total 30 6 30

Table-VI: Course of study for semester VI

Course No. of Credit


Name of the course Tutorial
code hours points
BP601T Medicinal Chemistry III – Theory 3 1 4
BP602T Pharmacology III – Theory 3 1 4
BP603T Herbal Drug Technology – Theory 3 1 4
Biopharmaceutics and Pharmacokinetics –
BP604T 3 1 4
Theory
BP605T Pharmaceutical Biotechnology – Theory 3 1 4
BP606T Quality Assurance –Theory 3 1 4
BP607T Eastern Himalayan Studies 3 1 4
BP608P Medicinal chemistry III – Practical 4 - 2
BP609P Pharmacology III – Practical 4 - 2
BP610P Herbal Drug Technology – Practical 4 - 2
Total 33 1 34
Table-VII: Course of study for semester VII

Course No. of Credit


Name of the course Tutorial
code hours points
BP701T Instrumental Methods of Analysis – Theory 3 1 4
BP702T Industrial PharmacyII – Theory 3 1 4
BP703T Pharmacy Practice – Theory 3 1 4
BP704T Novel Drug Delivery System – Theory 3 1 4
BP705P Instrumental Methods of Analysis – Practical 4 - 2
BP706PS Practice School 12 - 6
Total 28 5 24

Table-VIII: Course of study for semester VIII

Course No. of Credit


Name of the course Tutorial
code hours points
BP801T Biostatistics and Research Methodology 3 1 4
BP802T Social and Preventive Pharmacy 3 1 4
BP803ET Pharma Marketing Management
BP804ET Pharmaceutical Regulatory Science
BP805ET Pharmacovigilance
BP806ET Quality Control and Standardization of Herbals
BP807ET Computer Aided Drug Design 3+3= 4+4=
1+1=2
BP808ET Cell and Molecular Biology 6 8
BP809ET Cosmetic Science
BP810ET Experimental Pharmacology
BP811ET Advanced Instrumentation Techniques
BP812ET Dietary Supplements and Nutraceuticals
BP813PW Project Work 12 - 6
Total 24 4 22
Table-IX: Semester wise credits distribution

Semester Credit Points


I 27
II 26
III 24
IV 32
V 30
VI 34
VII 24
VIII 22
Extracurricular/ Co curricular activities 01*
Total credit points for the program 220

* The credit points assigned for extracurricular and or co-curricular activities shall be given by the
Principals of the colleges and the same shall be submitted to the University. The criteria to acquire this
credit point shall be defined by the colleges from time to time.
Tables-X: Schemes for internal assessments and end semester examinations semester wise
Semester I
Internal Assessment End Semester Exams
Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Human Anatomy and
BP101T 10 15 1 Hr 25 75 3 Hrs 100
Physiology I– Theory
Pharmaceutical Analysis I –
BP102T 10 15 1 Hr 25 75 3 Hrs 100
Theory
BP103T Pharmaceutics I – Theory 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical Inorganic
BP104T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry – Theory
BP105RBT Remedial Biology/
5/ 10/ 1 Hr 15/ 35/ 1.5 Hrs/ 50/
BP105RMT Mathematics – Theory
5 10 15 60 2.5 Hrs 75
Human Anatomy and
BP106P 5 10 4 Hrs 15 35 4 Hrs 50
Physiology – Practical
Pharmaceutical Analysis I –
BP107P 5 10 4 Hrs 15 35 4 Hrs 50
Practical
BP108P Pharmaceutics I – Practical 5 10 4 Hrs 15 35 4 Hrs 50
Pharmaceutical Inorganic
BP109P 5 10 4 Hrs 15 35 4 Hrs 50
Chemistry – Practical
Remedial Biology –
BP110RBP 5 5 2 Hrs 10 15 2 Hrs 25
Practical
# $ # $ # $ # $ # $
Total 70 /65 115 /110 23 Hrs 185 /175 490 /500 31.5 /30.5 Hrs 675

#
Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB)course.
$
Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics (RM)course.
Semester II

Internal Assessment End Semester Exams


Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Human Anatomy and Physiology
BP201T 10 15 1 Hr 25 75 3 Hrs 100
II – Theory
Pharmaceutical Organic
BP202T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry I – Theory
BP203T Biochemistry – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP204T Pathophysiology – Theory 10 15 1 Hr 25 75 3 Hrs 100
Computer Applications in
BP205T 10 15 1 Hr 25 50 2 Hrs 75
Pharmacy – Theory
Human Anatomy and Physiology
BP206P 5 10 4 Hrs 15 35 4 Hrs 50
II –Practical
Pharmaceutical Organic
BP207P 5 10 4 Hrs 15 35 4 Hrs 50
Chemistry I– Practical
BP208P Biochemistry – Practical 5 10 4 Hrs 15 35 4 Hrs 50
BP209P Computer Applications in
5 5 2 Hrs 10 15 2 Hrs 25
Pharmacy – Practical
Total 70 110 19 Hrs 180 470 28 Hrs 650
Semester III

Internal Assessment End Semester Exams


Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Pharmaceutical Organic
BP301T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry II – Theory
BP302T Physical Pharmaceutics I –Theory 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical Microbiology –
BP303T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutical Engineering –
BP304T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Pharmaceutical Organic
BP305P 5 10 4 Hr 15 35 4 Hrs 50
Chemistry II – Practical
BP306P Physical Pharmaceutics I –
5 10 4 Hr 15 35 4 Hrs 50
Practical
Pharmaceutical Microbiology –
BP307P 5 10 4 Hr 15 35 4 Hrs 50
Practical
Pharmaceutical Engineering –
BP308P 5 10 4 Hr 15 35 4 Hrs 50
Practical
Total 60 100 20 160 440 28Hrs 600
Semester IV

Internal Assessment End Semester Exams


Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Pharmaceutical Organic
BP401T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry III– Theory
BP402T Medicinal Chemistry I – Theory 10 15 1 Hr 25 75 3 Hrs 100
Physical Pharmaceutics II –
BP403T 10 15 1 Hr 25 75 3 Hrs 100
Theory
BP404T Pharmacology I – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP405T Pharmacognosy & Phytochemistry I 10 15 1 Hr 25 75 3 Hrs 100
– Theory
BP406T Communicative English 25 25 1 Hr 50 50 2 Hrs 100
BP407P Medicinal Chemistry I – Practical 5 10 4 Hr 15 35 4 Hrs 50
BP408P Physical Pharmaceutics II –
5 10 4 Hrs 15 35 4 Hrs 50
Practical
BP409P Pharmacology I – Practical 5 10 4 Hrs 15 35 4 Hrs 50
BP410P Pharmacognosy & Phytochemistry I 5 10 4 Hrs 15 35 4 Hrs 50
– Practical
Total 95 140 22 Hrs 235 565 33 Hrs 800
Semester V

Internal Assessment End Semester Exams


Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
BP501T Medicinal Chemistry II – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP502T Industrial Pharmacy I– Theory 10 15 1 Hr 25 75 3 Hrs 100
BP503T Pharmacology II – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP504T Pharmacognosy & Phytochemistry 10 15 1 Hr 25 75 3 Hrs 100
II – Theory
Pharmaceutical Jurisprudence –
BP505T 10 15 1 Hr 25 75 3 Hrs 100
Theory
BP506T Environmental Studies 25 25 1 Hr 50 50 2 Hrs 100
BP507P Industrial Pharmacy I– Practical 5 10 4 Hr 15 35 4 Hrs 50
BP508P Pharmacology II – Practical 5 10 4 Hr 15 35 4 Hrs 50
BP509P Pharmacognosy & Phytochemistry 5 10 4 Hr 15 35 4 Hrs 50
II – Practical
Total 90 120 18 Hr 220 530 29 Hrs 750
Semester VI

Internal Assessment End Semester Exams


Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
BP601T Medicinal Chemistry III – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP602T Pharmacology III – Theory 10 15 1 Hr 25 75 3 Hrs 100
Herbal Drug Technology –
BP603T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Biopharmaceutics and
BP604T 10 15 1 Hr 25 75 3 Hrs 100
Pharmacokinetics – Theory
Pharmaceutical Biotechnology–
BP605T 10 15 1 Hr 25 75 3 Hrs 100
Theory
BP606T Quality Assurance– Theory 10 15 1 Hr 25 75 3 Hrs 100
BP607T Eastern Himalayan Studies 25 25 1 Hr 50 50 2 Hrs 100
BP608P Medicinal chemistry III –
5 10 4 Hrs 15 35 4 Hrs 50
Practical
BP609P Pharmacology III – Practical 5 10 4 Hrs 15 35 4 Hrs 50
BP610P Herbal Drug Technology –
5 10 4 Hrs 15 35 4 Hrs 50
Practical
Total 10 145 19 Hrs 245 505 32 Hrs 900
00
Semester VII

End Semester
Internal Assessment
Course Exams Total
Name of the course
code Continuous Sessional Exams Marks
Total Marks Duration
Mode Marks Duration
Instrumental Methods of Analysis
BP701T 10 15 1 Hr 25 75 3 Hrs 100
– Theory
BP702T Industrial Pharmacy II – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP703T Pharmacy Practice – Theory 10 15 1 Hr 25 75 3 Hrs 100
Novel Drug Delivery System –
BP704T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Instrumental Methods of Analysis
BP705 P 5 10 4 Hrs 15 35 4 Hrs 50
– Practical
BP706 PS Practice School* 25 - - 25 125 5 Hrs 150
Total 70 70 8Hrs 140 460 21 Hrs 600
Semester VIII
Internal Assessment End Semester Exams
Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Biostatistics and Research
BP801T 10 15 1 Hr 25 75 3 Hrs 100
Methodology – Theory
Social and Preventive Pharmacy
BP802T 10 15 1 Hr 25 75 3 Hrs 100
– Theory
Pharmaceutical Marketing –
BP803ET
Theory
Pharmaceutical Regulatory
BP804ET
Science – Theory
BP805ET Pharmacovigilance – Theory
Quality Control and
BP806ET Standardization of Herbals –
Theory 10 + 10 15 + 15 = 1+1= 25 + 25 = 75 + 75 3+3=6 100 +
= 20 30 2 Hrs 50 = 150 Hrs 100 =
Computer Aided Drug Design –
BP807ET 200
Theory
Cell and Molecular Biology –
BP808ET
Theory
BP809ET Cosmetic Science – Theory
Experimental Pharmacology –
BP810ET
Theory
Advanced Instrumentation
BP811ET
Techniques – Theory
Dietary Supplements &
BP812ET
Neutraceuticals
BP813ET Pharmaceutical Product
Development
BP814PW Project Work - - - - 150 4 Hrs 150
Total 40 60 4 Hrs 100 450 16 Hrs 550
Internal assessment: Continuous mode
The marks allocated for Continuous mode of Internal Assessment shall be awarded as
per the scheme given below.

Table-XI: Scheme for awarding internal assessment: Continuous mode


Theory
Criteria Maximum
Marks
Attendance (Refer Table – XII) 4 2
Academic activities (Average of any 3 activities e.g. quiz, assignment,
3 1.5
open book test, field work, group discussion and seminar)
Student – Teacher interaction 3 1.5
Total 10 5
Practical
Attendance (Refer Table – XII) 2
Based on Practical Records, Regular viva voce, etc. 3
Total 5

Table- XII: Guidelines for the allotment of marks for attendance


Percentage of Attendance Theory Practical
95 – 100 4 2
90 – 94 3 1.5
85 – 89 2 1
80 – 84 1 0.5
Less than 80 0 0

Sessional Exams
Two Sessional exams shall be conducted for each theory / practical course as per the
schedule fixed by the college(s). The scheme of question paper for theory and practical
Sessional examinations is given below. The average marks of two Sessional exams shall
be computed for internal assessment as per the requirements given in tables – X.
Sessional exam shall be conducted for 30 marks for theory and shall be computed
for 15 marks. Similarly Sessional exam for practical shall be conducted for 40 marks and
shall be computed for 10 marks.

Question paper pattern for theory Sessional examinations

For subjects having University examination


I. Multiple Choice Questions (MCQs) = 10 x 1 = 10
OR OR
Objective Type Questions (5 x 2) = 05 x 2 = 10
(Answer all the questions)
I. Long Answers (Answer 1 out of 2) = 1 x 10 = 10
II. Short Answers (Answer 2 out of 3) = 2 x 5 = 10
-----------------
Total = 30 marks
For subjects having Non University Examination
I. Long Answers (Answer 1 out of 2) = 1 x 10 = 10
II. Short Answers (Answer 4 out of 6) = 4 x 5 = 20
------------------
Total = 30 marks
-----------------
Question paper pattern for practical sessional examinations
I. Synopsis = 10
II. Experiments = 25
III. Viva voce = 05
------------------
Total = 40 marks
------------------
Table-XIII: Tentative schedule of end semester examinations
Semester For Regular Candidates For Failed Candidates
I, III, V and VII November / December May / June
II, IV, VI and VIII May / June November / December

Question paper pattern for end semester theory examinations


For 75 marks paper
I. Multiple Choice Questions(MCQs) = 20 x 1 = 20
OR OR
Objective Type Questions (10 x 2) = 10 x 2 = 20
(Answer all the questions)
II. Long Answers (Answer 2 out of 3) = 2 x 10 = 20
III. Short Answers (Answer 7 out of 9) = 7 x 5 = 35
------------------
Total = 75 marks
------------------
For 50 marks paper
I. Long Answers (Answer 2 out of 3) = 2 x 10 = 20
II. Short Answers (Answer 6 out of 8) = 6 x 5 = 30
------------------
Total = 50 marks
------------------
For 35 marks paper
I. Long Answers (Answer 1 out of 2) = 1 x 10 =10
II. Short Answers (Answer 5 out of 7) = 5 x 5 = 25
------------------
Total = 35 marks
------------------
Question paper pattern for end semester practical examinations
I. Synopsis = 5
II. Experiments = 25
III. Viva voce = 5
------------------
Total = 35 marks
------------------
Letter grades and grade points allocations:
Based on the performances, each student shall be awarded a final letter grade at the end
of the semester for each course. The letter grades and their corresponding grade points are
given in Table – XIV.
Table – XIV: Letter grades and grade points equivalent to
Percentage of marks and performances
Percentage of
Marks Obtained Letter Grade Grade Point Performance
90.00 – 100 O 10 Outstanding
80.00 – 89.99 A 9 Excellent
70.00 – 79.99 B 8 Good
60.00 – 69.99 C 7 Fair
50.00 – 59.99 D 6 Average
Less than 50 F 0 Fail
Absent AB 0 Fail
A learner who remains absent for any end semester examination shall be assigned a letter
grade of ABand a corresponding grade point of zero. He/she should reappear for the said
evaluation/examination in due course.
The Semester grade point average (SGPA)
The performance of a student in a semester is indicated by a number called ‘Semester
Grade Point Average’ (SGPA). The SGPA is the weighted average of the grade points
obtainedin all the courses by the student during the semester. For example, if a student
takes five courses(Theory/Practical) in a semester with credits C1, C2, C3, C4 and C5
and the student’s grade pointsin these courses are G1, G2, G3, G4 and G5, respectively,
and then students’ SGPA is equal to:
C1G1 + C2G2 + C3G3 + C4G4+ C5 G5
SGPA = --------------------------------------------------
C1 + C2 + C3 + C4+ C5
The SGPA is calculated to two decimal points.It should be noted that, the SGPA for any
semester shall take into consideration the F and ABSgrade awarded in that semester. For
example if a learner has a F or ABS grade in course 4, theSGPA shall then be computed
as:
C1G1 + C2G2 + C3G3 + C4* ZERO + C5G5
SGPA = ------------------------------------------------------
C1 + C2 + C3 + C4+ C5
Cumulative Grade Point Average (CGPA)
The CGPA is calculated with the SGPA of all the VIII semesters to two decimal points
and is indicated in final grade report card/final transcript showing the grades of all VIII
semesters and their courses. The CGPA shall reflect the failed statusin case of F
grade(s),till the course(s) is/are passed. When the course(s)is/are passedby obtaining a
pass grade on subsequent examination(s) theCGPA shall only reflect the new grade and
not the fail grades earned earlier.The CGPA is calculated as:
C1S1 + C2S2 + C3S3 + C4S4+ C5S5 + C6S6+ C7S7+ C8S8
CGPA = -------------------------------------------------------------------------
C1 + C2 + C3 + C4+ C5+ C6+ C7+ C8
where C1, C2, C3,…. is the total number of credits for semester I,II,III,…. and S 1,S2, S3,….is
the SGPA of semester I,II,III,…. .

Declaration of class
The class shall be awarded on the basis of CGPA as follows:
First Class with Distinction = CGPA of. 7.50 and above
First Class = CGPA of 6.00 to 7.49
Second Class = CGPA of 5.00 to 5.99
Project work
All the students shall undertake a project under the supervision of a teacher and submit a
report. The area of the project shall directly relate any one of the elective subject opted by
the student in semester VIII. The project shall be carried out in group not exceeding 5 in
number. The project report shall be submitted in triplicate (typed & bound copy not less
than 25 pages).
The internal and external examiner appointed by the University shall evaluate the project
at the time of the Practical examinations of other semester(s). Students shall be evaluated
in groups for four hours (i.e., about half an hour for a group of five students). The
projects shall be evaluated as per the criteria given below.

Evaluation of Dissertation Book:

Objective(s) of the work done 15 Marks


Methodology adopted 20 Marks
Results and Discussions 20 Marks
Conclusions and Outcomes 20 Marks
Total 75 Marks
Evaluation of Presentation:
Presentation of work 25 Marks
Communication skills 20 Marks
Question and answer skills 30 Marks
Total 75 Marks
Semester I
BP101T. HUMAN ANATOMY AND PHYSIOLOGY-I (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure and
functions of the various systems of the human body. It also helps in understanding both
homeostatic mechanisms. The subject provides the basic knowledge required to
understand the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to
1. Explain the gross morphology, structure and functions of various organs of the human
body.
2. Describe the various homeostatic mechanisms and their imbalances.
3. Identify the various tissues and organs of different systems of human body.
4. Perform the various experiments related to special senses and nervous system.
5. Appreciate coordinated working pattern of different organs of each system

Course Content:
Unit I 10 hours
 Introduction to human body
Definition and scope of anatomy and physiology, levels of structural
organization and body systems, basic life processes, homeostasis, basic
anatomical terminology.
 Cellular level of organization
Structure and functions of cell, transport across cell membrane, cell
division, cell junctions. General principles of cell communication,
intracellular signaling pathway activation by extracellular signal
molecule, Forms of intracellular signaling: a) Contact-dependent b)
Paracrine c) Synaptic d) Endocrine
 Tissue level of organization
Classification of tissues, structure, location and functions of epithelial,
muscular and nervous and connective tissues.

Unit II 10 hours
 Integumentary system
Structure and functions of skin

 Skeletal system
Divisions of skeletal system, types of bone, salient features and functions
of bones of axial and appendicular skeletal system
Organization of skeletal muscle, physiology of muscle contraction,
neuromuscular junction
 Joints
Structural and functional classification, types of joints movements and its
articulation

Unit III 10 hours


 Body fluids and blood
 Body fluids, composition and functions of blood, hemopoeisis, formation of
hemoglobin, anemia, mechanisms of coagulation, blood grouping, Rh factors,
transfusion, its significance and disorders of blood, Reticulo endothelial system.
 Lymphatic system
Lymphatic organs and tissues, lymphatic vessels, lymph circulation and functions of
lymphatic system

Unit IV 08 hours
Peripheral nervous system:
Classification of peripheral nervous system: Structure and functions of
sympathetic and parasympathetic nervous system.
Origin and functions of spinal and cranial nerves.
 Special senses
Structure and functions of eye, ear, nose and tongue and their disorders.

Unit V 07 hours
 Cardiovascular system
Heart – anatomy of heart, blood circulation, blood vessels, structure and functions of
artery, vein and capillaries, elements of conduction system of heart and heart beat, its
regulation by autonomic nervous system, cardiac output, cardiac cycle. Regulation of
blood pressure, pulse, electrocardiogram and disorders of heart.
BP106P. HUMAN ANATOMY AND PHYSIOLOGY (Practical)
4 Hours/week
Practical physiology is complimentary to the theoretical discussions in
physiology. Practicals allow the verification of physiological processes discussed
in theory classes through experiments on living tissue, intact animals or normal
human beings. This is helpful for developing an insight on the subject.

1. Study of compound microscope.


2. Microscopic study of epithelial and connective tissue
3. Microscopic study of muscular and nervous tissue
4. Identification of axial bones
5. Identification of appendicular bones
6. Introduction to hemocytometry.
7. Enumeration of white blood cell (WBC) count
8. Enumeration of total red blood corpuscles (RBC) count
9. Determination of bleeding time
10. Determination of clotting time
11. Estimation of hemoglobin content
12. Determination of blood group.
13. Determination of erythrocyte sedimentation rate (ESR).
14. Determination of heart rate and pulse rate.
15. Recording of blood pressure.

Recommended Books (Latest Editions)


1. K. Sembulingam and P. Sembulingam, Essentials of Medical Physiology J aypee
brothers medical publishers, New Delhi.
2. Kathleen J.W. Wilson, Anatomy and Physiology in Health and Illness Churchill
Livingstone, New York
3. Best and Tailor. Williams & Wilkins, Physiological basis of Medical Practice-
Co, Riverview,MI, USA
4. C ,Guyton and John. E. Hall, Text book of Medical Physiology- Arthur. Miamisburg,
OH, U.S.A.
5. Tortora Grabowski, Principles of Anatomy and Physiology Palmetto, GA, U.S.A.
6. Inderbir Singh, Textbook of Human Histology, Jaypee brother’s medical publishers, New
Delhi.
7. C.L. Ghai ,Textbook of Practical Physiology, Jaypee brother’s medical publishers,
New Delhi.
8. K. Srinageswari and Rajeev Sharma, Practical workbook of Human Physiology by,
Jaypee brother’s medical publishers, New Delhi.
Reference Books (Latest Editions)
1. Best and Tailor. Physiological basis of Medical Practice- Williams & Wilkins Co,
Riverview, MI, USA
2. C, Guyton and John. E. Hall ,Text book of Medical Physiology- Arthur. Miamisburg, OH,
U.S.A.
3. Dr. C.C. Chatterrje , Human Physiology (vol 1 and 2) , Academic Publishers Kolkata
BP102T. PHARMACEUTICAL ANALYSIS (Theory)
45 Hours
Scope: This course deals with the fundamentals of analytical chemistry and principles of
electrochemical analysis of drugs

Objectives: Upon completion of the course student shall be able to


 understand the principles of volumetric and electro chemical analysis
 carryout various volumetric and electrochemical titrations
 develop analytical skills

Course Content:
UNIT-I 10 Hours
(a) Pharmaceutical analysis- Definition and scope
i) Different techniques of analysis
ii) Methods of expressing concentration
iii) Primary and secondary standards.
iv) Preparation and standardization of various molar and normal solutions-
Oxalic acid, sodium hydroxide, hydrochloric acid, sodium thiosulphate,
sulphuric acid, potassium permanganate and ceric ammonium sulphate
(b)Errors: Sources of errors, types of errors, methods of minimizing errors,
accuracy, precision and significant figures
(c)Pharmacopoeia, Sources of impurities in medicinal agents,limit tests.
UNIT-II 10 Hours
 Acid base titration: Theories of acid base indicators, classification of
acid base titrations and theory involved in titrations of strong, weak, and
very weak acids and bases, neutralization curves
 Non aqueous titration: Solvents, acidimetry and alkalimetry titration and
estimation of Sodium benzoate and Ephedrine HCl
UNIT-III 10 Hours
 Precipitation titrations: Mohr’s method, Volhard’s, Modified
Volhard’s, Fajans method, estimation of sodium chloride.
 Complexometric titration: Classification, metal ion indicators, masking
and demasking reagents, estimation of Magnesium sulphate, and calcium
gluconate.
 Gravimetry: Principle and steps involved in gravimetric analysis. Purity
of the precipitate: co-precipitation and post precipitation, Estimation of
barium sulphate.

 Basic Principles,methods and application of diazotisation titration.


UNIT-IV 08 Hours
Redox titrations
(a) Concepts of oxidation and reduction
(b) Types of redox titrations (Principles and applications)
Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry, Titration with
potassium iodate
UNIT-V 07 Hours
 Electrochemical methods of analysis
 Conductometry- Introduction, Conductivity cell, Conductometric
titrations, applications.
 Potentiometry - Electrochemical cell, construction and working
of reference (Standard hydrogen, silver chloride electrode and
calomel electrode) and indicator electrodes (metal electrodes and
glass electrode), methods to determine end point of potentiometric
titration and applications.
 Polarography - Principle, Ilkovic equation, construction and
working of dropping mercury electrode and rotating platinum
electrode, applications
BP107P. PHARMACEUTICAL ANALYSIS (Practical)
4 Hours / Week
I Limit Test of the following
(1) Chloride
(2) Sulphate
(3) Iron
(4) Arsenic

II Preparation and standardization of


(1) Sodium hydroxide
(2) Sulphuric acid
(3) Sodium thiosulfate
(4) Potassium permanganate
(5) Ceric ammonium sulphate
III Assay of the following compounds along with Standardization of Titrant
(1) Ammonium chloride by acid base titration
(2) Ferrous sulphate by Cerimetry
(3) Copper sulphate by Iodometry
(4) Calcium gluconate by complexometry
(5) Hydrogen peroxide by Permanganometry
(6) Sodium benzoate by non-aqueous titration
(7) Sodium Chloride by precipitation titration
IV Determination of Normality by electro-analytical methods
(1) Conductometric titration of strong acid against strong base
(2) Conductometric titration of strong acid and weak acid against strong base
(3) Potentiometric titration of strong acid against strong base

Recommended Books: (Latest Editions)

1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II, Stahlone
Press of University of London
2. A.I. Vogel, Text Book of Quantitative Inorganic analysis
3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry
4. Bentley and Driver's Textbook of Pharmaceutical Chemistry
5. John H. Kennedy, Analytical chemistry principles
6. Indian Pharmacopoeia, GOI, 2007.
7. P C Kamboj, Pharm. Analysis, Vol-I.
8. G. Vidya Sagar, Basics of Drug Analysis.
9. Ashutosh Kar, Pharmaceutical Drug Analysis.
10. Siddiqui & Siddiqui, Experimental Pharmaceutical Chemistry, 2nd edition.
BP103T. PHARMACEUTICS- I (Theory)
45 Hours
Scope: This course is designed to impart a fundamental knowledge on the preparatory
pharmacy with arts and science of preparing the different conventional dosage forms.
Objectives: Upon completion of this course the student should be able to:
 Know the history of profession of pharmacy
 Understand the basics of different dosage forms, pharmaceutical incompatibilities and
pharmaceutical calculations
 Understand the professional way of handling the prescription
 Preparation of various conventional dosage forms

Course Content:
UNIT – I 10 Hours
 Historical background and development of profession of pharmacy: History
of profession of Pharmacy in India in relation to pharmacy education, industry
and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP,
USP and Extra Pharmacopoeia.
 Dosage forms: Introduction to dosage forms, classification and definitions
 Prescription: Definition, Parts of prescription, handling of Prescription and
Errors in prescription.
 Posology: Definition, Factors affecting posology. Pediatric dose calculations
based on age, body weight and body surface area.
UNIT – II 10 Hours
 Pharmaceutical calculations: Weights and measures – Imperial & Metric
system, Calculations involving percentage solutions, alligation, proof spirit and
isotonic solutions based on freezing point and molecular weight.

 Powders: Definition, classification, advantages and disadvantages,Simple &


compound powders – official preparations, dusting powders, effervescent,
efflorescent and hygroscopic powders, eutectic mixtures. Geometric dilutions.

 Liquid dosage forms: Advantages and disadvantages of liquid dosage forms.


Excipients used in formulation of liquid dosage forms. Solubility enhancement
techniques
UNIT – III 08 Hours
 Monophasic liquids: Definitions and preparations of Gargles, Mouthwashes,
Throat Paint, Eardrops, Nasal drops, Enemas, Syrups, Elixirs, Liniments and
Lotions.
 Biphasic liquids:
 Suspensions: Definition, advantages and disadvantages, classifications,
Preparation of suspensions; Flocculated and Deflocculated suspension & stability
problems and methods to overcome.
 Emulsions: Definition, classification, emulsifying agent, test for the identification
of type ofEmulsion, Methods of preparation & stability problems and methods to
overcome.

UNIT – IV 08 Hours
 Suppositories: Definition, types, advantages and disadvantages, types of bases,
methods of preparations. Displacement value & its calculations, evaluation of
suppositories.
 Pharmaceutical incompatibilities: Definition, classification, physical, chemical
and therapeutic incompatibilities with examples.

UNIV – V 07 Hours
 Semisolid dosage forms: Definitions, classification, mechanisms and factors
influencing dermal penetration of drugs. Preparation of ointments, pastes, creams
and gels. Excipients used in semi solid dosage forms. Evaluation of semi solid
dosages forms
BP108P. PHARMACEUTICSI (Practical)
3 Hours / week

1 . Syrups a) Syrup IP’66


b) Compound syrup of Ferrous Phosphate BPC’68
2. Elixirs a) Piperazine citrate elixir
b) Paracetamol pediatric elixir
3.Linctus a) Terpin Hydrate Linctus IP’66
b) Iodine Throat Paint (Mandles Paint)
4. Solutions a) Strong solution of ammonium acetate b) Cresol with soap solution
c) Lugol’s solution
5. Suspensions
a) Calamine lotion
b) Magnesium Hydroxide mixture
c) Aluminimum Hydroxide gel
6. Emulsions a) Turpentine Liniment
b) Liquid paraffin emulsion
7. Powders and Granules
a) ORS powder (WHO)
b) Effervescent granules
c)Dusting powder
d)Divded powders
8. Suppositories
a) Glycero gelatin suppository
b) Coca butter suppository
c) Zinc Oxide suppository
8. Semisolids a) Sulphur ointment
b) Non staining-iodine ointment with methyl salicylate
c) Carbopal gel
9. Gargles and Mouthwashes
a) Iodine gargle
b) Chlorhexidine mouthwash

Recommended Books: (Latest Editions)


1. H.C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott
Williams and Walkins, New Delhi.
2. S J Carter, Cooper & Gunn’s-Dispensing for Pharmaceutical Students, CBS publishers, New
Delhi.
3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone,
Edinburgh.
4. Indian pharmacopoeia, GOI, 2007.
5. British pharmacopoeia, 1993
6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The
University of Michigan.
7. Alfonso R. Gennaro, Remington: The Science and Practice of Pharmacy, Lippincott
Williams, New Delhi.
8. S J Carter., Cooper and Gunn’s. Tutorial Pharmacy, CBS Publications, New Delhi.
9. E.A. Rawlins, Bentley’s Text Book of Pharmaceutics, English Language Book Society,
Elsevier Health Sciences, USA.
10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, INC, New
York.
BP104T. PHARMACEUTICAL INORGANIC CHEMISTRY (Theory)
45 Hours
Scope: This subject deals with the monographs of inorganic drugs and pharmaceuticals.
Objectives: Upon completion of course student shall be able to
 know the sources of impurities and methods to determine the impurities in inorganic
drugs and pharmaceuticals
 understand the medicinal and pharmaceutical importance of inorganic compounds
Course Content:
UNIT I 10 Hours
 Impurities in pharmaceutical substances: History of Pharmacopoeia,
Sources and types of impurities, principle involved in the limit test for
Chloride, Sulphate, Iron, Arsenic, Lead and Heavy metals, modified limit test
for Chloride and Sulphate
General methods of preparation, assay for the compounds superscripted
with asterisk (*), properties and medicinal uses of inorganic compounds
belonging to the following classes
UNIT II 10 Hours
 Acids, Bases and Buffers: Buffer equations and buffer capacity in general,
buffers in pharmaceutical systems, preparation, stability, buffered isotonic
solutions, measurements of tonicity, calculations and methods of adjusting
isotonicity.
 Major extra and intracellular electrolytes: Functions of major
physiological ions, Electrolytes used in the replacement therapy: Sodium
chloride*, Potassium chloride, Calcium gluconate* and Oral Rehydration Salt
(ORS), Physiological acid base balance.
 Dental products: Dentifrices, role of fluoride in the treatment of dental
caries, Desensitizing agents, Calcium carbonate, Sodium fluoride, and Zinc
eugenol cement.
UNIT III 10 Hours
 Gastrointestinal agents
Acidifiers: Ammonium chloride* and Dil. Cl
Antacid: Ideal properties of antacids, combinations of antacids, Sodium
Bicarbonate*, Aluminum hydroxide gel, Magnesium hydroxide mixture
Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin and Bentonite
Antimicrobials: Mechanism, classification, Potassium permanganate, Boric
acid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its preparations
UNIT IV 08 Hours
 Miscellaneous compounds
Expectorants: Potassium iodide, Ammonium chloride*.
Emetics: Copper sulphate*, Sodium potassium tartarate
Haematinics: Ferrous sulphate*, Ferrous gluconate
Poison and Antidote: Sodium thiosulphate*, Activated charcoal, Sodium nitrite333
Astringents: Zinc Sulphate, Potash Alum
UNIT V 07 Hours
 Radiopharmaceuticals: Radio activity, Measurement of radioactivity,
Properties of α, β, γ radiations, Half life, radio isotopes and study of radio
isotopes - Sodium iodide I131, Storage conditions, precautions &
pharmaceutical application of radioactive substances.
BP109P. PHARMACEUTICAL INORGANIC CHEMISTRY (Practical)
4 Hours / Week
I Limit tests for following ions
Limit test for Chlorides and Sulphates
Modified limit test for Chlorides and Sulphates
Limit test for Iron
Limit test for Heavy metals
Limit test for Lead
Limit test for Arsenic
II Identification test
Magnesium hydroxide
Ferrous sulphate
Sodium bicarbonate
Calcium gluconate
Copper sulphate
III Test for purity
Swelling power of Bentonite
Neutralizing capacity of aluminum hydroxide gel
Determination of potassium iodate and iodine in potassium Iodide
IV Preparation of inorganic pharmaceuticals
Boric acid
Potash alum
Ferrous sulphate

Recommended Books (Latest Editions)


1.A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,
Stahlone Press of University of London, 4th edition.
2.A.I. Vogel, Text Book of Quantitative Inorganic analysis
3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry, 3rd Edition
4. M.L Schroff, Inorganic Pharmaceutical Chemistry
5. Bentley and Driver's Textbook of Pharmaceutical Chemistry
6. Anand & Chatwal, Inorganic Pharmaceutical Chemistry
7. Indian Pharmacopoeia, GOI, 2007
8. Siddiqui & Siddiqui, Experimental Pharmaceutical Chemistry, 2nd edition.
9. Block Roche, Soine & Wilson, Inorganic Medicinal & Pharm. Chemistry.
10. KG Bothara, Inorganic Pharmceutical Chemistry.
11. B Subba Rao & Algarsamy, Practical Pharm. Inorganic Chemistry.
BP 105RBT. REMEDIAL BIOLOGY (Theory) 30 Hours

Scope: To learn and understand the components of living world, structure and functional
system of plant and animal kingdom.

Objectives: Upon completion of the course, the student shall be able to


 know the classification and salient features of five kingdoms of life
 understand the basic components of anatomy & physiology of plant
 know understand the basic components of anatomy & physiology animal with
special reference to human

UNIT I 07 Hours
Living world:
 Definition and characters of living organisms
 Diversity in the living world
 Binomial nomenclature
 Five kingdoms of life and basis of classification. Salient features of Monera,
Potista, Fungi, Animalia and Plantae, Virus,
Morphology of Flowering plants
 Morphology of different parts of flowering plants – Root, stem, inflorescence,
flower, leaf, fruit, seed.
 General Anatomy of Root, stem, leaf of monocotyledons & Dicotylidones.

UNIT II 07 Hours
Body fluids and circulation
 Composition of blood, blood groups, coagulation of blood
 Composition and functions of lymph
 Human circulatory system
 Structure of human heart and blood vessels
 Cardiac cycle, cardiac output and ECG
Digestion and Absorption
 Human alimentary canal and digestive glands
 Role of digestive enzymes
 Digestion, absorption and assimilation of digested food
Breathing and respiration
 Human respiratory system
 Mechanism of breathing and its regulation
 Exchange of gases, transport of gases and regulation of respiration
 Respiratory volumes
UNIT III 07 Hours
Excretory products and their elimination
 Modes of excretion
 Human excretory system- structure and function
 Urine formation
 Rennin angiotensin system
Neural control and coordination
 Definition and classification of nervous system
 Structure of a neuron
 Generation and conduction of nerve impulse
 Structure of brain and spinal cord
 Functions of cerebrum, cerebellum, hypothalamus and medulla oblongata
Chemical coordination and regulation
 Endocrine glands and their secretions
 Functions of hormones secreted by endocrine glands
Human reproduction
 Parts of female reproductive system
 Parts of male reproductive system
 Spermatogenesis and Oogenesis
 Menstrual cycle

UNIT IV 05 Hours
Plants and mineral nutrition:
 Essential mineral, macro and micronutrients
 Nitrogen metabolism, Nitrogen cycle, biological nitrogen fixation
Photosynthesis
 Autotrophic nutrition, photosynthesis, Photosynthetic pigments, Factors affecting
photosynthesis.

UNIT V 04 Hours
Plant respiration:Respiration, glycolysis, fermentation (anaerobic).
Plant growth and development
 Phases and rate of plant growth, Condition of growth,Introduction to plant growth
regulators
Cell - The unit of life
 Structure and functions of cell and cell organelles.Cell division
Tissues
 Definition, types of tissues, location and functions.

Recommended Books: a. S. B. Gokhale, Text book of Biology


b. Dr. Thulajappa and Dr. Seetaram ,A Text book of Biology.
Reference Books
a. B.V. Sreenivasa Naidu A Text book of Biology
b. Naidu and Murthy A Text book of Biology
c. A.C.Dutta, Botany for Degree students.
d. M. Ekambaranatha Ayyer and T. N. Ananthakrishnan, Outlines of Zoology.
e. S.B. Gokhale and C. K. Kokate, A manual for pharmaceutical biology practical
BP110RBP. REMEDIAL BIOLOGY (Practical)
30 Hours
1. Introduction to experiments in biology
a) Study of Microscope
b) Section cutting techniques
c) Mounting and staining
d) Permanent slide preparation
2. Study of cell and its inclusions
3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications
4. Detailed study of frog by using computer models
5. Microscopic study and identification of tissues pertinent to Stem, Root
Leaf, seed, fruit and flower
6. Identification of bones
7. Determination of blood group
8. Determination of blood pressure
9. Determination of tidal volume

Reference Books
1. S.R.Kale and R.R.Kale, Practical human anatomy and physiology.
2. S.B.Gokhale, C.K.Kokate and S.P.Shriwastava. A Manual of pharmaceutical biology
practical.
3. Prof .M.J.H.Shafi Biology practical manual according to National core curriculum
.Biology forum of Karnataka.
4. Cambell Biology, 11th edition.
5. Richa Bhatt. Modern Methods of Teaching Biology.
6. Singh, Pande & Jain. Text Book of Botany.
7. Dr. Punam Singh. Remedial Biology.
8. Shrishat, Singvi, Usman & Diwedi.Practical hand book of Remedial Biology.
BP 105RMT. REMEDIAL MATHEMATICS (Theory)

30 Hours

Scope: This is an introductory course in mathematics. This subject deals with the
introduction to Partial fraction, Logarithm, matrices and Determinant, Analytical
geometry, Calculus, differential equation and Laplace transform.

Objectives:Upon completion of the course the student shall be able to:-


1. Know the theory and their application in Pharmacy
2. Solve the different types of problems by applying theory
3. Appreciate the important application of mathematics in Pharmacy

Course Content:

UNIT – I 06 Hours
 Partial fraction
Introduction, Polynomial, Rational fractions, Proper and Improper fractions,
Partial fraction , Resolving into Partial fraction, Application of Partial
Fraction in Chemical Kinetics and Pharmacokinetics

 Logarithms
Introduction, Definition, Theorems/Properties of logarithms, Common
logarithms, Characteristic and Mantissa, worked examples, application of
logarithm to solve pharmaceutical problems.

 Function:
Real Valued function, Classification of real valued functions,

 Limits and continuity :


Introduction , Limit of a function, Definition of limit of a function ( - 
x n a n sin  
definition) , lim  na n1 , lim  1,
xa x  a  0 

UNIT –II 06 Hours


 Matrices and Determinant:
Introduction matrices, Types of matrices, Operation on matrices,
Transpose of a matrix, Matrix Multiplication, Determinants, Properties of
determinants , Product of determinants, Minors and co-Factors, Adjoint
or adjugate of a square matrix , Singular and non-singular matrices,
Inverse of a matrix, Solution of system of linear of equations using matrix
method, Cramer’s rule, Characteristic equation and roots of a square
matrix, Cayley–Hamilton theorem,Applicationof Matrices in solving
Pharmacokinetic equations
UNIT – III 06 Hours
 Calculus
Differentiation : Introductions, Derivative of a function, Derivative of a
constant, Derivative of a product of a constant and a function , Derivative of
the sum or difference of two functions, Derivative of the product of two
functions (product formula), Derivative of the quotient of two functions
(Quotient formula) – Without Proof, Derivative of xn w.r.tx,where n is any
rational number, Derivative of ex,, Derivative of loge x , Derivative of
ax,Derivative of trigonometric functions from first principles (without
Proof), Successive Differentiation, Conditions for a function to be a
maximum or a minimum at a point. Application

UNIT – IV 06 Hours
 Analytical Geometry
Introduction: Signs of the Coordinates, Distance formula,
Straight Line : Slope or gradient of a straight line, Conditions for
parallelism and perpendicularity of two lines, Slope of a line joining two
points, Slope – intercept form of a straight line
Integration:
Introduction, Definition, Standard formulae, Rules of integration , Method of
substitution, Method of Partial fractions, Integration by parts, definite
integrals, application
UNIT-V 06 Hours
 Differential Equations : Some basic definitions, Order and degree, Equations
in separable form , Homogeneous equations, Linear Differential equations,
Exact equations, Application in solving Pharmacokinetic equations
 Laplace Transform : Introduction, Definition, Properties of Laplace transform,
Laplace Transforms of elementary functions, Inverse Laplace transforms, Laplace
transform of derivatives, Application to solve Linear differential equations,
Application in solving Chemical kinetics and Pharmacokinetics equations

Recommended Books (Latest Edition)


1. Shanthinarayan. Differential Calculus.
2. Panchaksharappa Gowda D.H. Pharmaceutical Mathematics with application to
Pharmacy.
3. Shanthinarayan, Integral Calculus.
4. Dr.B.S.Grewal. Higher Engineering Mathematics.
5. Kapoor & Saxena. Mathematical Statistics.
6. CBSC. Text book of Mathematics,
7. Sreenivasa Rao & Nagraj.Text book of Mathematics.
8. A R Vasistha. Differential Equations.
9. J P Chouhan. Mathematical Foundation.
10. Vasistha & Agarwal, Advanced Mathematics for Pharmacist.
Semester II
BP 201T. HUMAN ANATOMY AND PHYSIOLOGY-II (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure and
functions of the various systems of the human body. It also helps in understanding both
homeostatic mechanisms. The subject provides the basic knowledge required to
understand the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to:
1. Explain the gross morphology, structure and functions of various organs of the
human body.
2. Describe the various homeostatic mechanisms and their imbalances.
3. Identify the various tissues and organs of different systems of human body.
4. Perform the hematological tests like blood cell counts, haemoglobin estimation,
bleeding/clotting time etc and also record blood pressure, heart rate, pulse and
respiratory volume.
5. Appreciate coordinated working pattern of different organs of each system
6. Appreciate the interlinked mechanisms in the maintenance of normal functioning
(homeostasis) of human body.
Course Content:
Unit I 10 hours

 Nervous system
Organization of nervous system, neuron, neuroglia, classification and
properties of nerve fibre, electrophysiology, action potential,
nerve impulse, receptors, synapse, neurotransmitters.
Central nervous system: Meninges, ventricles of brain and
cerebrospinal fluid.structure and functions of brain (cerebrum, brain
stem, cerebellum), spinal cord (gross structure, functions of afferent
and efferent nerve tracts,reflex activity)

Unit II 06 hours

 Digestive system
Anatomy of GI Tract with special reference to anatomy and functions of stomach,
( Acid production in the stomach, regulation of acid production through
parasympathetic nervous system, pepsin role in protein digestion) small intestine
and large intestine, anatomy and functions of salivary glands, pancreas and liver,
movements of GIT, digestion and absorption of nutrients and disorders of GIT.
 Energetics

Formation and role of ATP, Creatinine Phosphate and BMR.

Unit III
 Respiratory system 10 hours

Anatomy of respiratory system with special reference to anatomy of lungs,


mechanism of respiration, regulation of respiration

Lung Volumes and capacities transport of respiratory gases, artificial respiration,


and resuscitation methods.

 Urinary system
Anatomy of urinary tract with special reference to anatomy of kidney and
nephrons, functions of kidney and urinary tract, physiology of urine formation,
micturition reflex and role of kidneys in acid base balance, role of RAS in kidney
and disorders of kidney.

Unit IV 10 hours

 Endocrine system
Classification of hormones, mechanism of hormone action, structure
and functions of pituitary gland, thyroid gland, parathyroid gland,
adrenal
gland, pancreas, pineal gland, thymus and their disorders.

Unit V 09 hours
 Reproductive system
Anatomy of male and female reproductive system, Functions of male and female
reproductive system, sex hormones, physiology of menstruation, fertilization,
spermatogenesis, oogenesis, pregnancy and parturition
 Introduction to genetics
Chromosomes, genes and DNA, protein synthesis, genetic pattern of inheritance
BP 206 P. HUMAN ANATOMY AND PHYSIOLOGY (Practical)
4 Hours/week
Practical physiology is complimentary to the theoretical discussions in physiology. Practicals
allow the verification of physiological processes discussed in theory classes through experiments on
living tissue, intact animals or normal human beings. This is helpful for developing an insight on the
subject.

1. To study the integumentary and special senses using specimen, models, etc.,
2. To study the nervous system using specimen, models, etc.,
3. To study the endocrine system using specimen, models, etc
4. To demonstrate the general neurological examination
5. To demonstrate the function of olfactory nerve
6. To examine the different types of taste.
7. To demonstrate the visual acuity
8. To demonstrate the reflex activity
9. Recording of body temperature
10. To demonstrate positive and negative feedback mechanism.
11. Determination of tidal volume and vital capacity.
12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive
systems with the help of models, charts and specimens.
13. Recording of basal mass index .
14. Study of family planning devices and pregnancy diagnosis test.
15. Demonstration of total blood count by cell analyser
16. Permanent slides of vital organs and gonads.
Recommended Books (Latest Editions)
1. K. Sembulingam and P. Sembulingam. Essentials of Medical Physiology. Jaypee brothers
medical publishers, New Delhi.
2. Kathleen J.W. Wilson Anatomy and Physiology in Health and Illness, Churchill
Livingstone, New York
3. Best and Tailor. Physiological basis of Medical Practice. Williams & Wilkins
Co,Riverview,MI USA
4. C,Guyton and John.E. Hall, Text book of Medical Physiology. Miamisburg, OH, U.S.A.
5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.
6. Inderbir Singh. Textbook of Human Histology, Jaypee brothers medical publishers, New
Delhi.
7. C.L. Ghai. Textbook of Practical Physiology, Jaypee brothers medical publishers, New
Delhi.
8. K. Srinageswari and Rajeev Sharma, Practical workbook of Human Physiology. Jaypee
brother’s medical publishers, New Delhi.
Reference Books:
1. Best and Tailor. Physiological basis of Medical Practice Williams & Wilkins Co,
Riverview, MI USA
2. C, Guyton and John. E. Hall .Text book of Medical Physiology- Arthur. Miamisburg, OH,
U.S.A.
3. Dr. C.C. Chatterrje , Human Physiology (vol 1 and 2) by,Academic Publishers Kolkata
BP202T. PHARMACEUTICAL ORGANIC CHEMISTRY –I (Theory)
45 Hours
Scope: This subject deals with classification and nomenclature of simple organic compounds,
structural isomerism, intermediates forming in reactions, important physical properties, reactions
and methods of preparation of these compounds. The syllabus also emphasizes on mechanisms and
orientation of reactions.
Objectives: Upon completion of the course the student shall be able to
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. identify/confirm the identification of organic compound
Course Content:

General methods of preparation and reactions of compounds superscripted with asterisk (*) to be
explained
To emphasize on definition, types, classification, principles/mechanisms, applications, examples
and differences

UNIT-I 07 Hours
 Classification, nomenclature and isomerism
Classification of Organic Compounds
Common and IUPAC systems of nomenclature of organic compounds
(up to 10 Carbons open chain and carbocyclic compounds)
Structural isomerisms in organic compounds
UNIT-II 10 Hours
 Alkanes*, Alkenes* and Conjugated dienes*
SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins.
Stabilities of alkenes, SP2 hybridization in alkenes
E1 and E2 reactions – kinetics, order of reactivity of alkyl halides, rearrangement of
carbocations, Saytzeffs orientation and evidences. E1 verses E2 reactions, Factors affecting E1
and E2 reactions. Ozonolysis, electrophilic addition reactions of alkenes, Markownikoff’s
orientation, free radical addition reactions of alkenes, Anti Markownikoff’s orientation.
Stability of conjugated dienes, Diel-Alder, electrophilic addition, free radical addition
reactions of conjugated dienes, allylic rearrangement

UNIT-III 10 Hours
Alkyl halides*
SN1 and SN2 reactions - kinetics, order of reactivity of alkyl halides, stereochemistry and
rearrangement of carbocations.
SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions
Structure and uses of ethylchloride, Chloroform, trichloroethylene, tetrachloroethylene,
dichloromethane, tetrachloromethane and iodoform.
 Alcohols*- Qualitative tests, Structure and uses of Ethyl alcohol, Methyl alcohol,
chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol, Propylene glycol
UNIT-IV 10 Hours
 Carbonyl compounds* (Aldehydes and ketones)
Nucleophilic addition, Electromeric effect, aldol condensation, Crossed Aldol condensation,
Cannizzaro reaction, Crossed Cannizzaro reaction, Benzoin condensation, Perkin
condensation, qualitative tests, Structure and uses of Formaldehyde, Paraldehyde, Acetone,
Chloral hydrate, Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde.
UNIT-V 08 Hours
 Carboxylic acids*
Acidity of carbox ylic acids, effect of substituents on acidity, inductive effect and qualitative
tests for carboxylic acids ,amide and ester
Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid, Succinic acid. Oxalic
acid, Salicylic acid, Benzoic acid, Benzyl benzoate, Dimethyl phthalate, Methyl salicylate and
Acetyl salicylic acid
 Aliphatic amines* - Basicity, effect of substituent on Basicity. Qualitative test, Structure and
uses of Ethanolamine, Ethylenediamine, Amphetamine
BP207P. PHARMACEUTICAL ORGANIC CHEMISTRY -I (Practical)
4 Hours / week

1. Systematic qualitative analysis of unknown organic compounds like


1. Preliminary test: Color, odour, aliphatic/aromatic compounds, saturation
and unsaturation, etc.
2. Detection of elements like Nitrogen, Sulphur and Halogen by
Lassaigne’s test
3. Solubility test
4. Functional group test like Phenols, Amides/ Urea, Carbohydrates,
Amines, Carboxylic acids, Aldehydes and Ketones, Alcohols, Esters,
Aromatic and Halogenated Hydrocarbons, Nitro compounds and
Anilides.
5. Melting point/Boiling point of organic compounds
6. Identification of the unknown compound from the literature using
melting point/ boiling point.
7. Preparation of the derivatives and confirmation of the unknown
compound by melting point/ boiling point.
8. Minimum 5 unknown organic compounds to be analysed systematically.

2. Preparation of suitable solid derivatives from organic compounds

3. Construction of molecular models

Recommended Books (Latest Editions)


1. Morrison and Boyd, Organic Chemistry.
2. I.L. Finar, Organic Chemistry Volume-I
3. B.S. Bahl & Arun Bahl. Textbook of Organic Chemistry.
4. P.L.Soni. Organic Chemistry
5. Mann and Saunders. Practical Organic Chemistry.
6. Vogel’s text book of Practical Organic Chemistry
7. N.K.Vishnoi, Advanced Practical organic chemistry.
8. Pavia, Lampman and Kriz. Introduction to Organic Laboratory techniques.
9. Ahluwaliah/Chatwal. Reaction and reaction mechanism.
10. E L Ernest. Sterio chemistry of organic compounds.
BP203 T. BIOCHEMISTRY (Theory)
45 Hours
Scope: Biochemistry deals with complete understanding of the molecular levels of the chemical
process associated with living cells. The scope of the subject is providing biochemical facts and
the principles to understand metabolism of nutrient molecules in physiological and pathological
conditions. It is also emphasizing on genetic organization of mammalian genome and hetero &
autocatalytic functions of DNA.
Objectives: Upon completion of course student shell able to
1. Understand the catalytic role of enzymes, importance of enzyme inhibitors in design of new
drugs, therapeutic and diagnostic applications of enzymes.
2. Understand the metabolism of nutrient molecules in physiological and pathological
conditions.
3. Understand the genetic organization of mammalian genome and functions of
DNA in the synthesis of RNAs and proteins.

Course Content:

UNIT I 08 Hours
 Biomolecules
Introduction, classification, chemical nature and biological role of
carbohydrate, lipids, nucleic acids, amino acids and proteins.
 Bioenergetics
Concept of free energy, endergonic and exergonic reaction, Relationship between
free energy, enthalpy and entropy; Redox potential.
Energy rich compounds; classification; biological significances of ATP & cyclic AMP

UNIT II 10 Hours
 Carbohydrate metabolism
Glycolysis – Pathway, energetics and significance, Citric acid cycle- Pathway, energetics and
significance
HMP shunt and its significance; Glucose-6-Phosphate dehydrogenase (G6PD) deficiency
Glycogen metabolism Pathways and glycogen storage diseases (GSD)
Gluconeogenesis- Pathway and its significance
Hormonal regulation of blood glucose level and Diabetes mellitus
 Biological oxidation
Electron transport chain (ETC) and its mechanism.
Oxidative phosphorylation & its mechanism and substrate level phosphorylation
Inhibitors ETC and oxidative phosphorylation/Uncouplers
UNIT III 10 Hours

 Lipid metabolism
β-Oxidation of saturated fatty acid (Palmitic acid), Formation and utilization of ketone bodies;
ketoacidosis, De novo synthesis of fatty acids (Palmitic acid)
Biological significance of cholesterol and conversion of cholesterol into bile
acids, steroid hormone and vitamin D
Disorders of lipid metabolism: Hypercholesterolemia, atherosclerosis, fatty
liver and obesity.

 Amino acid metabolism


General reactions of amino acid metabolism: Transamination, deamination &
decarboxylation, urea cycle and its disorders
Catabolism of phenylalanine and tyrosine and their metabolic disorders (Phenyketonuria,
Albinism, alkeptonuria, tyrosinemia)
Synthesis and significance of biological substances; 5-HT, melatonin, dopamine,
noradrenaline, adrenaline
Catabolism of heme; hyperbilirubinemia and jaundice

UNIT IV 10 Hours
 Nucleic acid metabolism and genetic information transfer
Biosynthesis of purine and pyrimidine nucleotides
Catabolism of purine nucleotides and Hyperuricemia and Gout disease
Organization of mammalian genome
Structure of DNA and RNA and their functions DNA
replication (semi conservative model) Transcription or
RNA synthesis
Genetic code, Translation or Protein synthesis and inhibitors

UNIT V 07 Hours
 Enzymes
Introduction, properties, nomenclature and IUB classification of enzymes
Enzyme kinetics (Michaelis plot, Line Weaver Burke plot)
Enzyme inhibitors with examples
Regulation of enzymes: enzyme induction and repression, allosteric
enzymes regulation
Therapeutic and diagnostic applications of enzymes and isoenzymes
Coenzymes –Structure and biochemical functions
BP 208 P. BIOCHEMISTRY (Practical)
4 Hours / Week

1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose,


Sucrose and starch)
2. Identification tests for Proteins (albumin and Casein)
3. Quantitative analysis of reducing sugars (DNSA method) and Proteins
(Biuret method)
4. Qualitative analysis of urine for abnormal constituents
5. Determination of blood creatinine
6. Determination of blood sugar
7. Determination of serum total cholesterol
8. Preparation of buffer solution and measurement of pH
9. Study of enzymatic hydrolysis of starch
10. Determination of Salivary amylase activity
11. Study the effect of Temperature on Salivary amylase activity.
12. Study the effect of substrate concentration on salivary amylase activity.

Recommended Books (Latest Editions)


1. Lehninger. Principles of Biochemistry.
2. Robert K. Murry, Daryl K. Granner and Victor W. Harper’s Biochemistry. Rodwell.
3. Stryer. Biochemistry.
4. D. Satyanarayan and U.Chakrapani. Biochemistry.
5. Rama Rao. Textbook of Biochemistry.
6. K C Deb.Textbook of Biochemistry.
7. Conn and Stumpf. Outlines of Biochemistry.
8. R.C. Gupta and S. Bhargavan. Practical Biochemistry.
9. David T. Plummer. Introduction of Practical Biochemistry. (3rd Edition).
10. Rajagopal and Ramakrishna. Practical Biochemistry for Medical students.
11. Harold Varley. Practical Biochemistry.
BP 204T. PATHOPHYSIOLOGY (THEORY)
45Hours

Scope: Pathophysiology is the study of causes of diseases and reactions of the body to
such disease producing causes.This course is designed to impart a thorough knowledge of
the relevant aspects of pathology of various conditions with reference to its
pharmacological applications, and understanding of basic pathophysiological
mechanisms. Hence it will not only help to study the syllabus of pathology, but also to
get baseline knowledge required to practice medicine safely, confidently, rationally and
effectively.

Objectives: Upon completion of the subject student shall be able to –


1. Describe the etiology and pathogenesis of the selected disease states;
2. Name the signs and symptoms of the diseases; and
3. Mention the complications of the diseases.

Course content:
Unit I 10Hours
 Basic principles of Cell injury and Adaptation:
Introduction, definitions, Homeostasis, Components and Types of Feedback systems, Causes of cellular
injury,Pathogenesis (Cell membrane damage, Mitochondrial damage, Ribosome damage, Nuclear
damage),Morphology of cell injury – Adaptive changes (Atrophy, Hypertrophy, hyperplasia, Metaplasia,
Dysplasia),Cell swelling, Intra cellular accumulation, Calcification, Enzyme leakage and
Cell Death Acidosis
&Alkalosis,Electrolyte imbalance
 Basic mechanism involved in the process of inflammation and repair:
Introduction, Clinical signs of inflammation, Different types of Inflammation,Mechanism of
Inflammation – Alteration in vascular permeability and blood flow, migration of WBC’s,Mediators
of inflammation,Basic principles of wound healing in the skin,Pathophysiology of Atherosclerosis
Unit II 10Hours
 Cardiovascular System:
Hypertension, congestive heart failure, ischemic heart disease (angina,myocardial infarction,
atherosclerosis and arteriosclerosis)
 Respiratory system:Asthma, Chronic obstructive airways diseases.
 Renal system:Acute and chronic renal failure .

Unit III 10Hours


 Haematological Diseases:
Iron deficiency, megaloblastic anemia (Vit B12 and folic acid), sickle cell anemia,
thalasemia, hereditary acquired anemia, hemophilia
 Endocrine system: Diabetes, thyroid diseases, disorders of sex hormones
 Nervous system: Epilepsy, Parkinson’s disease, stroke, psychiatric disorders:
depression, schizophrenia and Alzheimer’s disease.
 Gastrointestinal system: Peptic Ulcer
Unit IV 8 Hours
 Inflammatory bowel diseases, jaundice, hepatitis (A,B,C,D,E,F) alcoholic liver
disease.
 Disease of bones and joints: Rheumatoid arthritis, osteoporosis and gout
 Principles of cancer: classification, etiology and pathogenesis of cancer
 Diseases of bones and joints:Rheumatoid Arthritis, Osteoporosis,Gout
 Principles of Cancer: Classification, etiology and pathogenesis of Cancer

Unit V 7 Hours
 Infectious diseases:Meningitis,Typhoid, Leprosy, Tuberculosis, Urinary tract infections
 Sexually transmitted diseases:AIDS, Syphilis, Gonorrhea

Recommended Books (Latest Editions)

1. Vinay Kumar, Abul K. Abas, Jon C. Aster; Robbins &Cotran Pathologic Basis of
Disease; South Asia edition; India; Elsevier; 2014.
2. Harsh Mohan; Text book of Pathology; 6th edition; India; Jaypee Publications; 2010.
3. Laurence B, Bruce C, Bjorn K. ; Goodman Gilman’s The Pharmacological Basis of
Therapeutics; 12th edition; New York; McGraw-Hill; 2011.
4. Best, Charles Herbert 1899-1978; Taylor, Norman Burke 1885-1972; West, John B
(John Burnard); Best and Taylor’s Physiological basis of medical practice; 12th ed;
united states;
5. William and Wilkins, Baltimore;1991 [1990 printing].
6. Nicki R. Colledge, Brian R. Walker, Stuart H. Ralston;Davidson’s Principles and Practice
of Medicine; 21st edition; London; ELBS/Churchill Livingstone; 2010.
7. Guyton A, John .E Hall; Textbook of Medical Physiology; 12 th edition; WB Saunders
Company; 2010.
8. Joseph DiPiro, Robert L. Talbert, Gary Yee, Barbara Wells, L. Michael Posey;
Pharmacotherapy: A Pathophysiological Approach; 9th edition; London; McGraw-Hill
Medical; 2014.
9. V. Kumar, R. S. Cotran and S. L. Robbins; Basic Pathology; 6th edition; Philadelphia;
WB Saunders Company; 1997.
rd
10. Roger Walker, Clive Edwards; Clinical Pharmacy and Therapeutics; 3 edition; London;
Churchill Livingstone publication; 2003.

Recommended Journals
1. The Journal of Pathology. ISSN: 1096-9896 (Online)
2. The American Journal of Pathology. ISSN: 0002-9440
3. Pathology. 1465-3931 (Online)
4. International Journal of Physiology, Pathophysiology and Pharmacology. ISSN: 1944-8171
(Online)
5. Indian Journal of Pathology and Microbiology. ISSN-0377-4929.
BP205 T. COMPUTER APPLICATIONS IN PHARMACY (Theory)

30 Hrs (2 Hrs/Week)

Scope: This subject deals with the introduction Database, Database Management system,
computer application in clinical studies and use of databases.
Objectives: Upon completion of the course the student shall be able to
1. know the various types of application of computers in pharmacy
2. know the various types of databases
3. know the various applications of databases in pharmacy

Course content:
UNIT – I 06 hours
Number system: Binary number system, Decimal number system, Octal number
system, Hexadecimal number systems, conversion decimal to binary, binary to
decimal, octal to binary etc, binary addition, binary subtraction – One’s
complement ,Two’s complement method, binary multiplication, binary division
Concept of Information Systems and Software : Information gathering,
requirement and feasibility analysis, data flow diagrams, process specifications,
input/output design, process life cycle, planning and managing the project
UNIT –II 06 hours

Web technologies:Introduction to HTML, XML,CSS and Programming


languages, introduction to web servers and Server Products
Introduction to databases, MYSQL, MS ACCESS, Pharmacy Drug database
UNIT – III 06 hours
Application of computers in Pharmacy – Drug information storage and retrieval,
Pharmacokinetics, Mathematical model in Drug design, Hospital and Clinical
Pharmacy, Electronic Prescribing and discharge (EP) systems, barcode medicine
identification and automated dispensing of drugs, mobile technology and adherence
monitoring

Diagnostic System, Lab-diagnostic System, Patient Monitoring System, Pharma


Information System
UNIT – IV 06 hours

Bioinformatics: Introduction, Objective of Bioinformatics, Bioinformatics Databases,


Concept of Bioinformatics, Impact of Bioinformatics in Vaccine Discovery

UNIT-V 06 hours

Computers as data analysis in Preclinical development:


Chromatographic dada analysis(CDS), Laboratory Information management
System (LIMS) and Text Information Management System(TIMS)
BP209P. COMPUTER APPLICATIONS IN PHARMACY (Practical)

1. Design a questionnaire using a word processing package to gather information


about a particular disease.
2. Create a HTML web page to show personal information.
3 Retrieve the information of a drug and its adverse effects using online tools
4 Creating mailing labels Using Label Wizard , generating label in MS WORD
5 Create a database in MS Access to store the patient information with the required
fields Using access
6. Design a form in MS Access to view, add, delete and modify the patient record in
the database
7. Generating report and printing the report from patient database
8. Creating invoice table using – MS Access
9. Drug information storage and retrieval using MS Access
10. Creating and working with queries in MS Access
11. Exporting Tables, Queries, Forms and Reports to web pages
12. Exporting Tables, Queries, Forms and Reports to XML pages

Recommended books (Latest edition):

1. William E.Fassett. Computer Application in Pharmacy ,Lea and Febiger, 600


South Washington Square, USA, (215) 922-1330.
2. Sean Ekins, Computer Application in Pharmaceutical Research and Development,
Wiley-Interscience, A John Willey and Sons, INC., Publication, USA
3. S.C.Rastogi Bioinformatics (Concept, Skills and Applications), CBS Publishers and
Distributors, 4596/1- A, 11 Darya Gani, New Delhi – 110 002(INDIA)
4. Cary N.Prague. Microsoft office Access - 2003, Application Development Using
VBA, SQL Server, DAP and Infopath, Wiley Dreamtech India (P) Ltd., 4435/7,
Ansari Road, Daryagani, New Delhi – 110002
5. E. Balaguruswamy. Progamming in ANSIC, Tata McGraw Hill, 1997.
6. C. Nellai Kannan. Microsoft Office.
7. N Hunt & J Shelly. Computer and Comminsence.
8. Tanen Baum. Computer Networks.
9. P Perrum. Computer Aided Drug design, Academic Press, New York.
10. P K Sinha & P Sinha. Computer Fundamentals.
SEMESTER III
BP301T. PHARMACEUTICAL ORGANIC CHEMISTRY –II (Theory)
45 Hours
Scope: This subject deals with general methods of preparation and reactions of some organic
compounds. Reactivity of organic compounds are also studied here. The syllabus emphasizes on
mechanisms and orientation of reactions. Chemistry of fats and oils are also included in the
syllabus.
Objectives: Upon completion of the course the student shall be able to
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. prepare organic compounds
Course Content:
General methods of preparation and reactions of compounds superscripted with asterisk (*) to be explained
To emphasize on definition, types, classification, principles/mechanisms, applications, examples & differences
UNIT I 10 Hours
 Benzene and its derivatives
A. Analytical, synthetic and other evidences in the derivation of structure ofbenzene,
Orbital picture, resonance in benzene, aromatic characters, Huckel’s rule
B. Reactions of benzene - nitration, sulphonation, halogenation- reactivity,
Friedelcrafts alkylation- reactivity, limitations, Friedelcrafts acylation.
C. Substituents, effect of substituents on reactivity and orientation of mono
substituted benzene compounds towards electrophilic substitution reaction
D. Structure and uses of DDT, Saccharin, BHC and Chloramine
UNIT II 10 Hours
 Phenols* - Acidity of phenols, effect of substituents on acidity, qualitative
tests, Structure and uses of phenol, cresols, resorcinol, naphthols
 Aromatic Amines* - Basicity of amines, effect of substituents on basicity, and
synthetic uses of aryl diazonium salts
 Aromatic Acids* –Acidity, effect of substituents on acidit y and im
portant reactions of benzoic acid.
UNIT III 10 Hours
 Fats and Oils
a. Fatty acids – reactions.
b. Hydrolysis, Hydrogenation, Saponification and Rancidity of oils, Drying oils.
c. Analytical constants – Acid value, Saponification value, Ester value, Iodine
value, Acetyl value, Reichert Meissl (RM) value – significance and principle
involved in their determination.
UNIT IV 08 Hours
 Polynuclear hydrocarbons:
a. Synthesis, reactions
b. Structure and medicinal uses of Naphthalene, Phenanthrene, Anthracene,
Diphenylmethane, Triphenylmethane and their derivatives
UNIT V 07 Hours
 Cyclo alkanes*
Stabilities – Baeyer’s strain theory, limitation of Baeyer’s strain theory, Coulson and Moffitt’s
modification, Sachse Mohr’s theory (Theory of strainless rings), reactions of cyclopropane and
cyclobutane only
BP305P. PHARMACEUTICAL ORGANIC CHEMISTRY-II (Practical)
4 Hrs/week

I Experiments involving laboratory techniques


 Recrystallization
 Steam distillation
II Determination o f following o i l values ( including standardization of
reagents)
 Acid value
 Saponification value
 Iodine value
III Preparation of compounds
 Benzanilide/Phenyl benzoate/Acetanilide from Aniline/ Phenol
/Aniline by acylation reaction.
 2,4,6-Tribromo aniline/Para bromo acetanilide from Aniline/
 Acetanilide by halogenation (Bromination) reaction.
 5-Nitro salicylic acid/Meta di nitro benzene from Salicylic acid /
Nitro benzene by nitration reaction.
 Benzoic acid from Benzyl chloride by oxidation reaction.
 Benzoic acid/ Salicylic acid from alkyl benzoate/ alkyl salicylate by
hydrolysis reaction.
 1-Phenyl azo-2-napthol from Aniline by diazotization and coupling
reactions.
 Benzil from Benzoin by oxidation reaction.
 Dibenzal acetone from Benzaldehyde by Claison Schmidt reaction
 Cinnammic acid from Benzaldehyde by Perkin reaction
 P-Iodo benzoic acid from P-amino benzoic acid

Recommended Books (Latest Editions)


1. Morrison and Boyd. Organic Chemistry.
2. I.L. Finar. Organic Chemistry, Volume-I
3. B.S. Bahl & Arun Bahl. Textbook of Organic Chemistry.
4. P.L.Soni. Organic Chemistry
5. Mann and Saunders. Practical Organic Chemistry.
6. Vogel’s text book of Practical Organic Chemistry
7. N.K.Vishnoi. Advanced Practical organic chemistry.
8. Pavia, Lampman and Kriz.Introduction to Organic Laboratory techniques.
9. OP Agarwal, Organic chemistry reactions & Reagents.
10. Beckett & Stenlake, Practical Pramaceutical Chemistry, Vol I & II.
BP302T. PHYSICAL PHARMACEUTICS-I (Theory)
45Hours

Scope: The course deals with the various physical and physicochemical properties, and principles
involved in dosage forms/formulations. Theory and practical components of the subject
help the student to get a better insight into various areas of formulation research and
development, and stability studies of pharmaceutical dosage forms.

Objectives: Upon the completion of the course student shall be able to


1. Understand various physicochemical properties of drug molecules in the designing
the dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing and
determination of expiry date of formulations
3. Demonstrate use of physicochemical properties in the formulation development and
evaluation of dosage forms.
Course Content:
UNIT-I 10 Hours
Solubility of drugs: Solubility expressions, mechanisms of solute solvent interactions, ideal
solubility parameters, solvation & association, quantitative approach to the factors influencing
solubility of drugs, diffusion principles in biological systems. Solubility of gas in liquids,
solubility of liquids in liquids, (Binary solutions, ideal solutions) Raoult’s law, real solutions.
Partially miscible liquids, Critical solution temperature and applications. Distribution law, its
limitations and applications

UNIT-II 10Hours
States of Matter and properties of matter :State of matter, changes in the state of matter, latent
heats, vapour pressure, sublimation critical point, eutectic mixtures, gases, aerosols
– inhalers, relative humidity, liquid complexes, liquid crystals, glassy states, solid-
crystalline, amorphous & polymorphism.
Physicochemical properties of drug molecules: Refractive index, optical rotation,
dielectric constant, dipole moment, dissociation constant, determinations and applications

UNIT-III 08 Hours
Surface and interfacial phenomenon: Liquid interface, surface & interfacial tensions,
surface free energy, measurement of surface & interfacial tensions, spreading coefficient,
adsorption at liquid interfaces, surface active agents, HLB Scale, solubilisation,
detergency, adsorption at solid interface.

UNIT-IV 08Hours
Complexation and protein binding: Introduction, Classification of Complexation, Applications,
methods of analysis, protein binding, Complexation and drug action, crystalline structures of
complexes and thermodynamic treatment of stability constants.

UNIT-V 07 Hours
pH, buffers and Isotonic solutions: Sorensen’s pH scale, pH determination
(electrometric and calorimetric), applications of buffers, buffer equation, buffer capacity, buffers
in pharmaceutical and biological systems, buffered isotonic solutions.
BP306P. PHYSICAL PHARMACEUTICS – I (Practical)
4 Hrs/week
1. Determination the solubility of drug at room temperature

2. Determination of pKa value by Half Neutralization/ Henderson Hasselbalch


equation.
3. Determination of Partition co- efficient of benzoic acid in benzene and water
4. Determination of Partition co- efficient of Iodine in CCl4 and water
5. Determination of % composition of NaCl in a solution using phenol-water system by
CST method
6. Determination of surface tension of given liquids by drop count and drop weight
method
7. Determination of HLB number of a surfactant by saponification method
8. Determination of Freundlich and Langmuir constants using activated char coal
9. Determination of critical micellar concentration of surfactants
10. Determination of stability constant and donor acceptor ratio of PABA-Caffeine
complex by solubility method
11. Determination of stability constant and donor acceptor ratio of Cupric-Glycine
complex by pH titration method

Recommended Books: (Latest Editions)

1. Alfred Martin. Physical Pharmacy.


2. Eugene, Parott. Experimental Pharmaceutics.
3. Cooper and Gunn. Tutorial Pharmacy.
4. J Stocklosam. Pharmaceutical Calculations, Lea & Febiger, Philadelphia.
5. H A Liberman, C Lachman., Pharmaceutical Dosage forms, Tablets, Volume-1 to
3, MarcelDekkar Inc.
6. H A Liberman, C Lachman, Pharmaceutical Dosage forms.
Disperse systems, volume 1, 2, 3. Marcel Dekkar Inc.
7. C Ramasamy and R Manavalan. Physical Pharmaceutics.
8. C.V.S. Subramanyam, J. Thimma settee. Laboratory Manual of Physical
Pharmaceutics.
9. C.V.S. Subramanyam. Physical Pharmaceutics.
10. Gaurav Jain & Roop K. Khar. Text book of Physical Phramacy.
BP 303 T. PHARMACEUTICAL MICROBIOLOGY (Theory)

45Hours
Scope:
 Study of all categories of microorganisims especially for the production of alchol
antibiotics, vaccines, vitamins enzymes etc.
Objectives: Upon completion of the subject student shall be able to;
1. Understand methods of identification, cultivation and preservation of various microorganisms
2. To understand the importance and implementation of sterlization in pharmaceutical processing
and industry
3. Learn sterility testing of pharmaceutical products.
4. Carried out microbiological standardization of Pharmaceuticals.
5. Understand the cell culture technology and its applications in pharmaceutical industries.

Course content:

Unit I 10 Hours
Introduction, history of microbiology, its branches, scope and its
importance.
Introduction to Prokaryotes and Eukaryotes
Study of ultra-structure and morphological classification of bacteria,
nutritional requirements, raw materials used for culture media and physical
parameters for growth, growth curve, isolation and preservation methods
for pure cultures, cultivation of anaerobes, quantitative measurement of
bacterial growth (total & viable count).
Study of different types of phase constrast microscopy, dark field
microscopy and electron microscopy.
Unit II 10 Hours

Identification of bacteria using staining techniques (simple, Gram’s &Acid


fast staining) and biochemical tests (IMViC).
Study of principle, procedure, merits, demerits and applications of physical,
chemical gaseous,radiation and mechanical method of sterilization.
Evaluation of the efficiency of sterilization methods.
Equipments employed in large scale sterilization.
Sterility indicators
Unit III 10 Hours

Study of morphology, classification, reproduction/replication and


cultivation of Fungi and Viruses.
Classification and mode of action of disinfectants
Factors influencing disinfection, antiseptics and their evaluation. For
bacteriostatic and bactericidal actions
Evaluation of bactericidal & Bacteriostatic.
Sterility testing of products (solids, liquids, ophthalmic and other sterile
products) according to IP, BP and USP.

Unit IV 08 Hours
Designing of aseptic area, laminar flow equipments; study of different
sources of contamination in an aseptic area and methods of prevention,
clean area classification.
Principles and methods of different microbiological assay. Methods for
standardization of antibiotics, vitamins and amino acids.
Assessment of a new antibiotic.
Unit V 07Hours

Types of spoilage, factors affecting the microbial spoilage of


pharmaceutical products, sources and types of microbial contaminants,
assessment of microbial contamination and spoilage.
Preservation of pharmaceutical products using antimicrobial agents,
evaluation of microbial stability of formulations.
Growth of animal cells in culture, general procedure for cell culture,
Primary, established and transformed cell cultures.
Application of cell cultures in pharmaceutical industry and research.
BP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical)
4 Hrs/week

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator,
laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator,
microscopes used in experimental microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.
4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with
practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other
techniques.
6. Microbiological assay of antibiotics by cup plate method and other methods
7. Motility determination by Hanging drop method.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test.

Recommended Books (Latest edition)

1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific


publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
13. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly company
BP 304 T. PHARMACEUTICAL ENGINEERING (Theory)
45 Hours
Scope: This course is designed to impart a fundamental knowledge on the art and science of
various unit operations used in pharmaceutical industry.
Objectives: Upon completion of the course student shall be able:
1. To know various unit operations used in Pharmaceutical industries.
2. To understand the material handling techniques.
3. To perform various processes involved in pharmaceutical manufacturing process.
4. To carry out various test to prevent environmental pollution.
5. To appreciate and comprehend significance of plant lay out design for optimum use of resources.
6. To appreciate the various preventive methods used for corrosion control in
Pharmaceutical industries.

Course content:
UNIT-I 10 Hours
 Flow of fluids: Types of manometers, Reynolds number and its significance, Bernoulli’s
theorem and its applications, Energy losses, Orifice meter, Venturimeter, Pitot tube and
Rotometer.
 Size Reduction: Objectives, Mechanisms & Laws governing size reduction, factors
affecting size reduction, principles, construction, working, uses, merits and demerits of Hammer
mill, ball mill, fluid energy mill, Edge runner mill & end runner mill.
 Size Separation: Objectives, applications & mechanism of size separation, official
standards of powders, sieves, size separation Principles, construction, working, uses, merits and
demerits of Sieve shaker, cyclone separator, Air separator, Bag filter & elutriation tank.

UNIT-II 10 Hours

 Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier’s law, Heat
transfer by conduction, convection & radiation. Heat interchangers & heat exchangers.
 Evaporation: Objectives, applications and factors influencing evaporation, differences
between evaporation and other heat process. principles, construction, working, uses, merits and
demerits of Steam jacketed kettle, horizontal tube evaporator, climbing film evaporator,
forced circulation evaporator, multiple effect evaporator& Economy of multiple effect
evaporator.
 Distillation: Basic Principles and methodology of simple distillation,flash distillation,
fractional distillation, distillation under reduced pressure, steam distillation & molecular
distillation

UNIT- III 08 Hours


 Drying: Objectives, applications & mechanism of drying process, measurements & applications
of Equilibrium Moisture content, rate of drying curve. principles, construction, working, uses,
merits and demerits of Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer,
freeze dryer.
 Mixing: Objectives, applications & factors affecting mixing, Difference between solid and
liquid mixing, mechanism of solid mixing, liquids mixing and semisolids mixing.
Principles, Construction, Working, uses, Merits and Demerits of Double cone blender, twin
shell blender, ribbon blender, Sigma blade mixer, planetary mixers, Propellers, Turbines, Paddles
& Silverson Emulsifier,

UNIT-IV 08 Hours
 Filtration: Objectives, applications, Theories & Factors influencing filtration, filter aids,
filter medias. Principle, Construction, Working, Uses, Merits and demerits of plate & frame
filter, filter leaf, rotary drum filter, Meta filter & Cartridge filter, membrane filters and
Seidtz filter.
 Centrifugation: Objectives, principle & applications of Centrifugation, principles,
construction, working, uses, merits and demerits of Perforated basket centrifuge, Non-perforated
basket centrifuge, semi continuous centrifuge & super centrifuge.
UNIT- V 07 Hours

 Materials of pharmaceutical plant construction, Corrosion and its prevention:


Factors affecting during materials selected for Pharmaceutical plant construction, Theories of
corrosion, types of corrosion and there prevention. Ferrous and nonferrous metals,
inorganic and organic non-metals, basic of material handling systems.

Recommended Books: (Latest Editions)


1. Walter L Badger & Julius Banchero. Introduction to chemical engineering, Latest
edition.
2. Nigel J.K. Simpson. Solid phase extraction, Principles, techniques and applications -
Latest edition.
3. Mcabe Smith. Unit operation of chemical engineering , Latest edition.
4. C.V.S Subrahmanyam et al., Pharmaceutical engineering principles and practices –Latest
edition.
5. Remington practice of pharmacy- Martin, Latest edition.
6. Lachmann. Theory and practice of industrial pharmacy, Latest edition.
7. C.V.S Subrahmanyam et al. Physical pharmaceutics- Latest edition.
8. S.J. Carter. Cooper and Gunn’s Tutorial pharmacy, Latest edition.
9. Manavalan & Ramasamy. Physical Pharmaceutics.
10. KH Joseph & Boka Hadzija. Basic Physical Pharmacy.
BP308P - PHARMACEUTICAL ENGINEERING (Practical)

4 Hours/week

I. Determination of radiation constant of brass, iron, unpainted and painted glass.


II. Steam distillation – To calculate the efficiency of steam distillation.
III. To determine the overall heat transfer coefficient by heat exchanger.
IV. Construction of drying curves (for calcium carbonate and starch).
V. Determination of moisture content and loss on drying.
VI. Determination of humidity of air – i) From wet and dry bulb temperatures –use of
Dew point method.
VII. Description of Construction working and application of Pharmaceutical
Machinery such as rotary tablet machine, fluidized bed coater, fluid energy mill,
de humidifier.
VIII. Size analysis by sieving – To evaluate size distribution of tablet granulations –
Construction of various size frequency curves including arithmetic
andlogarithmic probability plots.
IX. Size reduction: To verify the laws of size reduction using ball mill and
determining Kicks, Rittinger’s, Bond’s coefficients, power requirement and
critical speed of Ball Mill.
X. Demonstration of colloid mill, planetary mixer, fluidized bed dryer, freeze dryer
and such othermajor equipment.
XI. Factors affecting Rate of Filtration and Evaporation (Surface area, Concentration
and Thickness/ viscosity
XII. To study the effect of time on the Rate of Crystallization.
XIII. To calculate the uniformity Index for given sample by using Double Cone
Blender.
SEMESTER IV
BP401T. PHARMACEUTICAL ORGANIC CHEMISTRY –III (Theory)
45 Hours
Scope: This subject imparts knowledge on stereo-chemical aspects of organic compounds and
organic reactions, important named reactions, chemistry of important hetero cyclic compounds.
It also emphasizes on medicinal and other uses of organic compounds.
Objectives: At the end of the course, the student shall be able to
1. understand the methods of preparation and properties of organic compounds
2. explain the stereo chemical aspects of organic compounds and stereo chemical reactions
3. know the medicinal uses and other applications of organic compounds
Course Content:
Note: To emphasize on definition, types, mechanisms, examples, uses/applications
UNIT-I 10 Hours
Stereo isomerism
Optical isomerism – Optical activity, enantiomerism, diastereoisomerism, meso compounds
Elements of symmetry, chiral and achiral molecules, DL system of nomenclature of optical
isomers, sequence rules, RS system of nomenclature of optical isomers, Reactions of chiral
molecules, Racemic modification and resolution of racemic mixture. Asymmetric synthesis: partial
and absolute
UNIT-II 10 Hours
Geometrical isomerism- Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)
Methods of determination of configuration of geometrical isomers. Conformational isomerism in
Ethane, n-Butane and Cyclohexane. Stereo isomerism in biphenyl compounds (Atropisomerism)
and conditions for optical activity. Stereospecific and stereoselective reactions
UNIT-III 10 Hours
Heterocyclic compounds: Nomenclature and classification, Synthesis, reactions and medicinal uses
of following compounds/derivatives, Pyrrole, Furan, and Thiophene, Relative aromaticity and
reactivity of Pyrrole, Furan and Thiophene
UNIT-IV 0 8 Hours
Synthesis, reactions and medicinal uses of following compounds/derivatives, Pyrazole, Imidazole,
Oxazole and Thiazole., Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine,
Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their derivatives
UNIT-V 07 Hours
Reactions of synthetic importance
Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, Birch reduction,
Wolff Kishner reduction. Oppenauer-oxidation and Dakin reaction. Beckmanns rearrangement and
Schmidt rearrangement. Claisen-Schmidt condensation
Recommended Books (Latest Editions)
1. I.L. Finar. Organic chemistry, Volume-I & II.
2. Arun Bahl, B.S. Bahl. A text book of organic chemistry.
3. Raj K. Bansal. Heterocyclic Chemistry.
4. Morrison and Boyd. Organic Chemistry.
5. T.L. Gilchrist. Heterocyclic Chemistry.
6. OP Agarwal, Organic chemistry Reactions & Reagents.
7. EL Ernest, Sterio chemistry of Organic compounds.
8. Beckett & Stenlake, Pharmaceutival Chemistry.
9. Indian Pharmacopoeia, GOI, 2007.
10. Remington, The Science & Practice of Pharmacy.
BP402T. MEDICINAL CHEMISTRY – I (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and
therapeutic value of drugs. The subject emphasizes on structure activity relationships of drugs,
importance of physicochemical properties and metabolism of drugs. The syllabus also
emphasizes on chemical synthesis of important drugs under each class.
Objectives: Upon completion of the course the student shall be able to
1. understand the chemistry of drugs with respect to their pharmacological activity
2. understand the drug metabolic pathways, adverse effect and therapeutic value of drugs
3. know the Structural Activity Relationship (SAR) of different class of drugs
4. write the chemical synthesis of some drugs
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism of action, uses
of drugs mentioned in the course, Structure activity relationship of selective class of drugs as
specified in the course and synthesis of drugs superscripted (*)

UNIT- I 10 Hours
Introduction to Medicinal Chemistry, History and development of medicinal chemistry
Physicochemical properties in relation to biological action, Ionization, Solubility, Partition Coefficient,
Hydrogen bonding, Protein binding, Chelation, Bioisosterism, Optical and Geometrical isomerism.
Drug metabolism- Drug metabolism principles- Phase I and Phase II.
Factors affecting drug metabolism including stereo chemical aspects.

UNIT- II 10 Hours
Drugs acting on Autonomic Nervous System
Adrenergic Neurotransmitters: Biosynthesis and catabolism of catecholamine. Adrenergic receptors
(Alpha & Beta) and their distribution.
Sympathomimetic agents: SAR of Sympathomimetic agents, Direct acting: Nor-epinephrine,
Epinephrine, Phenylephrine*, Dopamine, Methyldopa, Clonidine, Dobutamine, Isoproterenol,
Terbutaline, Salbutamol*, Bitolterol, Naphazoline, Oxymetazoline and Xylometazoline. Indirect acting
agents: Hydroxyamphetamine, Pseudoephedrine, Propylhexedrine.
Agents with mixed mechanism: Ephedrine, Metaraminol.
Adrenergic Antagonists:
Alpha adrenergic blockers: Tolazoline*, Phentolamine, Phenoxybenzamine, Prazosin,
Dihydroergotamine, Methysergide.
Beta adrenergic blockers: SAR of beta blockers, Propranolol*, Metibranolol, Atenolol,
Betazolol, Bisoprolol, Esmolol, Metoprolol, Labetolol, Carvedilol.

UNIT-III 10 Hours
Cholinergic neurotransmitters: Biosynthesis and catabolism of acetylcholine. Cholinergic receptors
(Muscarinic & Nicotinic) and their distribution.
Parasympathomimetic agents: SAR of Parasympathomimetic agents, Direct acting agents:
Acetylcholine, Carbachol*, Bethanechol, Methacholine, Pilocarpine. Indirect acting/ Cholinesterase
inhibitors (Reversible & Irreversible): Physostigmine, Neostigmine*, Pyridostigmine, Edrophonium
chloride, Tacrine hydrochloride, Ambenonium chloride, Isofluorphate, Echothiophate iodide,
Parathione, Malathion.
Cholinesterase reactivator: Pralidoxime chloride.
Cholinergic Blocking agents: SAR of cholinolytic agents
Solanaceous alkaloids and analogues: Atropine sulphate, Hyoscyamine sulphate,
Scopolamine hydrobromide, Homatropine hydrobromide, Ipratropium bromide*.
Synthetic cholinergic blocking agents: Tropicamide, Cyclopentolate hydrochloride, Clidinium bromide,
Dicyclomine hydrochloride*, Glycopyrrolate, Methantheline bromide, Propantheline bromide,
Benztropine mesylate, Orphenadrine citrate, Biperidine hydrochloride, Procyclidine hydrochloride*,
Tridihexethyl chloride, Isopropamide iodide, Ethopropazine hydrochloride.
A.Sedatives and Hypnotics:
Benzodiazepines: SAR of Benzodiazepines, Chlordiazepoxide, Diazepam*, Oxazepam, Chlorazepate,
Lorazepam, Alprazolam, Zolpidem
Barbiturtes: SAR of barbiturates, Barbital*, Phenobarbital, Mephobarbital, Amobarbital, Butabarbital,
Pentobarbital, Secobarbital
Miscelleneous: Amides & imides: Glutethmide., Alcohol & their carbamate derivatives: Meprobomate,
Ethchlorvynol. Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.
B. Antipsychotics
Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride, Chlorpromazine hydrochloride*,
Triflupromazine, Thioridazine hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,
Trifluoperazine hydrochloride.
Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene, Loxapine succinate, Clozapine.
Fluro buterophenones: Haloperidol, Droperidol, Risperidone.
Beta amino ketones: Molindone hydrochloride.
Benzamides: Sulpieride.

C. Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant action


Barbiturates: Phenobarbitone, Methabarbital.
Hydantoins: Phenytoin*, Mephenytoin, Ethotoin
Oxazolidine diones: Trimethadione, Paramethadione
Succinimides: Phensuximide, Methsuximide, Ethosuximide*
Urea and monoacylureas: Phenacemide, Carbamazepine*
Benzodiazepines: Clonazepam
Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate

UNIT – V 07 Hours
Drugs acting on Central Nervous System
General anesthetics: Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane, Sevoflurane,
Isoflurane, Desflurane.
Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal sodium, Thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride.*
Narcotic and non-narcotic analgesics
Morphine and related drugs: SAR of Morphine analogues, Morphine sulphate, Codeine, Meperidine
hydrochloride, Anilerdine hydrochloride, Diphenoxylate hydrochloride, Loperamide hydrochloride,
Fentanyl citrate*, Methadone hydrochloride*, Propoxyphene hydrochloride, Pentazocine, Levorphanol
tartarate.
Narcotic antagonists: Nalorphine hydrochloride, Levallorphan tartarate, Naloxone hydrochloride.
Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*, Meclofenamate,
Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac, Ketorolac, Ibuprofen*, Naproxen,
Piroxicam, Phenacetin, Acetaminophen, Antipyrine, Phenylbutazone.
BP407P. MEDICINAL CHEMISTRY – I (Practical)
4 Hours/Week

I Preparation of drugs/ intermediates

1 1,3-pyrazole
2 1,3-oxazole
3 Benzimidazole
4 Benztriazole
5 2,3- diphenyl quinoxaline
6 Benzocaine
7 Phenytoin
8 Phenothiazine
9 Barbiturate

II Assay of drugs

1 Chlorpromazine
2 Phenobarbitone
3 Atropine
4 Ibuprofen
5 Aspirin
6 Furosemide

III Determination of Partition coefficient for any two drugs

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Smith and Williams. Introduction to principles of drug design.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. I.L. Finar. Organic Chemistry, Vol. II.
8. Lednicer. The Organic Chemistry of Drug Synthesis, Vol. 1-5.
9. Indian Pharmacopoeia, GOI, 2007.
10. A.I.Vogel. Text book of practical organic chemistry.
BP 403 T. PHYSICAL PHARMACEUTICS-II (Theory)
45Hours
Scope: The course deals with the various physical and physicochemical properties, and principles
involved in dosage forms/formulations. Theory and practical components of the subject help
the student to get a better insight into various areas of formulation research and
development, and stability studies of pharmaceutical dosage forms.

Objectives: Upon the completion of the course student shall be able to


1. Understand v a r i o u s physicochemical properties of drug molecules in the designing
the dosage forms.
2. Know the principles of chemical kinetics & to use them for stability testing and determination of
expiry date of formulations.
3. Demonstrate use of physicochemical properties in the formulation development and evaluation of
dosage forms.
Course Content:
UNIT-I 07 Hours
Colloidal dispersions: Classification of dispersed systems & their general characteristics,
size & shapes of colloidal particles, classification of colloids & comparative account of
their general properties. Optical, kinetic & electrical properties. Effect of electrolytes, coacervation,
peptization& protective action.
UNIT-II 10 Hours
Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of temperature, non-
Newtonian systems, pseudoplastic, dilatant, plastic, thixotropy, thixotropy in formulation,
determination of viscosity, capillary, falling Sphere, rotational viscometers.
Deformation of solids: Plastic & elastic deformation, Heckel equation, Stress, Strain, Elastic Modulus.

UNIT-III 10 Hours
Coarse dispersion: Suspension, interfacial properties of suspended particles, settling in suspensions,
formulation of flocculated and deflocculated suspensions. Emulsions and theories of emulsification,
microemulsion and multiple emulsions; Stability of emulsions, preservation of emulsions,
rheological properties of emulsions and emulsion formulation by HLB method.

UNIT-IV 10Hours
Micromeretics: Particle size and distribution, mean particle size, number and weight distribution,
particle number, methods for determining particle size by different methods, counting and
separation method, particle shape, specific surface, methods for determining surface area,
permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities,
bulkiness & flow properties.
UNIT-V 10 Hours
Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order, units of basic rate
constants, determination of reaction order. Physical and chemical factors influencing the chemical
degradation of pharmaceutical product: temperature, solvent, ionic strength, dielectric constant,
specific & general acid base catalysis, Simple numerical problems. Stabilization of medicinal
agents against common reactions like hydrolysis & oxidation. Accelerated stability testing in
expiration dating of pharmaceutical dosage forms. Photolytic degradation and its prevention.
BP 408P. PHYSICAL PHARMACEUTICS- II (Practical)
3 Hrs/week

1. Determination of particle size, particle size distribution using sieving method


2. Determination of particle size, particle size distribution using Microscopic method
3. Determination of bulk density, true density and porosity
4. Determine the angle of repose and influence of lubricant on angle of repose

5. Determination of viscosity of liquid using Ostwald’s viscometer


6. Determination sedimentation volume with effect of different suspending agent
7. Determination sedimentation volume with effect of different concentration of
single suspending agent
8. Determination of viscosity of semisolid by using Brookfield viscometer
9. Determination of reaction rate constant first order.
10. Determination of reaction rate constant second order
11. Accelerated stability studies

Recommended Books: (Latest Editions)


1. Alfred Martin. Physical Pharmacy, Sixth edition.
2. Eugene & Parott. Experimental pharmaceutics.
3. Cooper and Gunn. Tutorial pharmacy.
4. J Stocklosam. Pharmaceutical calculations, Lea & Febiger, Philadelphia.
5. H A Liberman, C Lachman, Pharmaceutical Dosage forms, Tablets, Volume-1 to 3,
Marcel Dekkar Inc.
6. Aulton. Pharmaceutics: Science & Design of dosage forms.
7. C Ramasamy and R Manavalan.Physical Pharmaceutics.
8. C.V.S Subrahmanyam et al., Physical pharmaceutics- Latest edition.
9. G Jain. Theory & Practice of Physical Pharmacy.
10. KH Joseph & Boka Hadzija. Basic Physical Pharmacy.
BP 404 T. PHARMACOLOGY-I (Theory)
45 Hrs
Scope: The main purpose of the subject is to understand what drugs do to the living
organisms and how their effects can be applied to therapeutics. The subject covers the
information about the drugs like, mechanism of action, physiological and biochemical
effects (pharmacodynamics) as well as absorption, distribution, metabolism and excretion
(pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses,
contraindications and routes of administration of different classes of drugs.
Objectives: Upon completion of this course the student should be able to
1. Understand the pharmacological actions of different categories of drugs
2. Explain the mechanism of drug action at organ system/sub cellular/
macromolecular levels.
3. Apply the basic pharmacological knowledge in the prevention and treatment of
various diseases.
4. Observe the effect of drugs on animals by simulated experiments
5. Appreciate correlation of pharmacology with other bio medical sciences
Course Content:
UNIT-I 08 hours
1. General Pharmacology
a. Introduction to Pharmacology- Definition, historical landmarks and scope of
pharmacology, nature and source of drugs, essential drugs concept and routes of
drug administration, Agonists, antagonists( competitive and non competitive), spare
receptors, addiction, tolerance, dependence, tachyphylaxis, idiosyncrasy, allergy.
b. Pharmacokinetics- Membrane transport, absorption, distribution, metabolism and
excretion of drugs .Enzyme induction, enzyme inhibition, kinetics of elimination
UNIT-II 12 Hours

General Pharmacology
a. Pharmacodynamics- Principles and mechanisms of drug action. Receptor theories
and classification of receptors, regulation of receptors. drug receptors interactions
signal transduction mechanisms, G-protein–coupled receptors, ion channel receptor,
transmembrane enzyme linked receptors, transmembrane JAK-STAT binding
receptor and receptors that regulate transcription factors, dose response
relationship, therapeutic index, combined effects of drugs and factors modifying
drug action.
b. Adverse drug reactions.
c. Drug interactions (pharmacokinetic and pharmacodynamic)
d. Drug discovery and clinical evaluation of new drugs -Drug discovery phase,
preclinical evaluation phase, clinical trial phase, phases of clinical trials and
pharmacovigilance.
UNIT-III 10 Hours
2. Pharmacology of drugs acting on peripheral nervous system
a. Organization and function of ANS.
b.Neurohumoral transmission,co-transmission and classification of neurotransmitters.
c. Parasympathomimetics, Parasympatholytics, Sympathomimetics, sympatholytics.
d. Neuromuscular blocking agents and skeletal muscle relaxants (peripheral).
e. Local anesthetic agents.
f. Drugs used in myasthenia gravis and glaucoma

UNIT-IV 08 Hours
3. Pharmacology of drugs acting on central nervous system
a. Neurohumoral transmission in the C.N.S.special emphasis on importance of various
neurotransmitters like with GABA, Glutamate, Glycine, serotonin, dopamine.
b. General anesthetics and pre-anesthetics.
c. Sedatives, hypnotics and centrally acting muscle relaxants.
d. Anti-epileptics
e. Alcohols and disulfiram

UNIT-V 07 Hours
3. Pharmacology of drugs acting on central nervous system
a. Psychopharmacological agents: Antipsychotics, antidepressants, anti-anxiety agents,
anti-manics and hallucinogens.
b. Drugs used in Parkinsons disease and Alzheimer’s disease.
c. CNS stimulants and nootropics.
d. Opioid analgesics and antagonists
e. Drug addiction, drug abuse, tolerance and dependence.
BP 409P.PHARMACOLOGY-I (Practical)
4Hrs/Week
1. Introduction to experimental pharmacology.
2. Commonly used instruments in experimental pharmacology.
3. Study of common laboratory animals.
4. Maintenance of laboratory animals as per CPCSEA guidelines.
5. Common laboratory techniques. Blood withdrawal, serum and plasma separation,
anesthetics and euthanasia used for animal studies.
6. Study of different routes of drugs administration in mice/rats.
7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping
time in mice.
8. Effect of drugs on ciliary motility of frog oesophagus
9. Effect of drugs on rabbit eye.
10. Effects of skeletal muscle relaxants using rota-rod apparatus.
11. Effect of drugs on locomotor activity using actophotometer.
12. Anticonvulsant effect of drugs by MES and PTZ method.
13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.
14. Study of anxiolytic activity of drugs using rats/mice.
15. Study of local anesthetics by different methods
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos

Recommended Books (Latest Editions)


1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s Pharmacology,.Churchil
Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata McGraw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A.
K., Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers (P) Ltd,
New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company,
Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
BP 405 T.PHARMACOGNOSY AND PHYTOCHEMISTRY I (Theory)
45 Hours
Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of
crude drugs, their identification and evaluation, phytochemicals present in them and their
medicinal properties.

Objectives: Upon completion of the course, the student shall be able


1. to know the techniques in the cultivation and production of crude drugs
2. to know the crude drugs, their uses and chemical nature
3. know the evaluation techniques for the herbal drugs
4. to carry out the microscopic and morphological evaluation of crude drugs

Course Content:

UNIT-I 10 Hours
Introduction to Pharmacognosy:
(a) Definition, history, scope and development of Pharmacognosy
(b) Sources of Drugs – Plants, Animals, Marine & Tissue culture
(c) Organized drugs, unorganized drugs (dried latex, dried juices, dried extracts, gums and
mucilages, oleoresins and oleo- gum -resins).

Classification of drugs:
Alphabetical, morphological, taxonomical, chemical, pharmacological, chemo and sero
taxonomical classification of drugs

Quality control of Drugs of Natural Origin:


Adulteration of drugs of natural origin. Evaluation by organoleptic, microscopic, physical,
chemical and biological methods and properties.

Quantitative microscopy of crude drugs including lycopodium spore method, leafconstants,


camera lucida and diagrams of microscopic objects to scale with camera lucida.

UNIT-II 10 Hours
Cultivation, Collection, Processing and storage of drugs of natural origin:
Cultivation and Collection of drugs of natural origin
Factors influencing cultivation of medicinal plants.
Plant hormones and their applications.
Polyploidy, mutation and hybridization with reference to medicinal plants

Conservation of medicinal plants

UNIT-III 07 Hours
Plant tissue culture:
Historical development of plant tissue culture, types of cultures, Nutritional requirements,
growth and their maintenance.
Applications of plant tissue culture in pharmacognosy.
Edible vaccines
UNIT IV 10 Hours
Pharmacognosy in various systems of medicine:
Role of Pharmacognosy in allopathy and traditional systems of medicine namely, Ayurveda,
Unani, Siddha, Homeopathy and Chinese systems of medicine.

Introduction to secondary metabolites:


Definition, classification, properties and test for identification of Alkaloids, Glycosides,
Flavonoids, Tannins, Volatile oil and Resins

UNIT V 08 Hours
Study of biological source, chemical nature and uses of drugs of natural origin containing
following drugs
Plant Products:
Fibers - Cotton, Jute, Hemp
Hallucinogens, Teratogens, Natural allergens

Primary metabolites:
General introduction, detailed study with respect to chemistry, sources, preparation,
evaluation, preservation, storage, therapeutic used and commercial utility as Pharmaceutical
Aids and/or Medicines for the following Primary metabolites:
Carbohydrates: Acacia, Agar, Tragacanth, Honey
Proteins and Enzymes : Gelatin, casein, proteolytic enzymes (Papain, bromelain,
serratiopeptidase, urokinase, streptokinase, pepsin).
Lipids(Waxes, fats, fixed oils) : Castor oil, Chaulmoogra oil, Wool Fat, Bees Wax
Marine Drugs:
Novel medicinal agents from marine sources
BP410 P. PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)
4 Hours/Week
1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv)
Gelatin (v) starch (vi) Honey (vii) Castor oil
2. Determination of stomatal number and index
3. Determination of vein islet number, vein islet termination and paliside ratio.
4. Determination of size of starch grains, calcium oxalate crystals by eye piece
micrometer
5. Determination of Fiber length and width
6. Determination of number of starch grains by Lycopodium spore method
7. Determination of Ash value
8. Determination of Extractive values of crude drugs
9. Determination of moisture content of crude drugs
10. Determination of swelling index and foaming

Recommended Books: (Latest Editions)


1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. V E Tyler, L R Brady, and J E Robbers, Pharmacognosy, 9th Edn., Lea and
Febiger, Philadelphia, 1988.
3. T.E. Wallis .Text Book of Pharmacognosy.
4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers &
Distribution, New Delhi.
5. C.K. Kokate, Purohit, Gokhlae. Text book of Pharmacognosy (2007), 37th Edition,
Nirali Prakashan, New Delhi.
6. R.D. Choudhary. Herbal drug industry (1996), Ist Edn, Eastern Publisher, New
Delhi.
7. Dr.SH.Ansari. Essentials of Pharmacognosy, IInd edition, Birla publications, New
Delhi, 2007.
8. C.K. Kokate, Purohit, Gokhlae. Practical Pharmacognosy.
9. M.A. Iyengar. Anatomy of Crude Drugs.
10. V D Rangari. Pharmacognosy and Phytochemistry vol-I and II.
BP 406 T. COMMUNICATION ENGLISH

100 MARKS CREDIT-4

UNIT I.
Tense and Concord
Basic Transformations: Positive and Negative Sentences
Simple, Complex and Compound Sentences
Change of Voice

UNIT II.
Change of Narration
Question Tag and Short Responses
Preposition and Determiners
Some Common Errors in English

UNIT III.
Reading Comprehension and Writing Skill
Reading Comprehension (Practice of Unseen
Passages) Essay on Literal, Cultural and Legal
Topics
Formal and Informal Correspondence

UNIT IV.
Précis Writing
Report Writing: Status and Policy Reports
Writing Proposals

Reading List:
1. Bolton, David and Noel Goodey (2005) English Grammar in Steps. Orient Blackswan; New
Delhi.
2. Eastwood, John. (1999) Oxford Practice Grammar.Oxford University Press; New Delhi.
3. Hewings, Martin. (2007) Advanced Grammar in Use. Cambridge University Press; New Delhi.
4. Murphy, Raymond. (2000) Essential Grammar in Use. Cambridge University Press; New Delhi.
5. Quirk, Randolph and Greenbaum, (1985) A University Grammar of English. Essex; ELBS.
Longman.
6. Swan, Michael and Walter, Catherine. (2006) The Good English Grammar Book.Oxford
University
Press; New Delhi.
7. Swan,
SEMESTER V
BP501T. MEDICINAL CHEMISTRY – II (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and
therapeutic value of drugs. The subject emphasizes on structure activity relationships of drugs,
importance of physicochemical properties and metabolism of drugs. The syllabus also
emphasizes on chemical synthesis of important drugs under each class.
Objectives: Upon completion of the course the student shall be able to
1. Understand the chemistry of drugs with respect to their pharmacological activity
2. Understand the drug metabolic pathways, adverse effect and therapeutic value of drugs
3. Know the Structural Activity Relationship of different class of drugs
4. Study the chemical synthesis of selected drugs
Course Content:

Study of the development of the following classes of drugs, Classification,


mechanism of action, uses of drugs mentioned in the course, Structure activity
relationship of selective class of drugs as specified in the course and synthesis of drugs
superscripted (*)

UNIT- I 10 Hours
Antihistaminic agents: Histamine, receptors and their distribution in the human body
H1–antagonists:Diphenhydramine hydrochloride*, Dimenhydrinate, Doxylamines cuccinate,
Clemastine fumarate, Diphenylphyraline hydrochloride, Tripelenamine hydrochloride,
Chlorcyclizine hydrochloride, Meclizine hydrochloride, Buclizine hydrochloride,
Chlorpheniramine maleate, Triprolidine hydrochloride*, Phenidamine tartarate, Promethazine
hydrochloride*, Trimeprazine tartrate, Cyproheptadine hydrochloride, Azatidine maleate,
Astemizole, Loratadine, Cetirizine, Levocetrazine Cromolyn sodium. H2-antagonists: Cimetidine*,
Famotidine, Ranitidin. Gastric Proton pump inhibitors:Omeprazole, Lansoprazole,
Rabeprazole, Pantoprazole
Anti-neoplastic agents: Alkylating agents: Meclorethamine*, Cyclophosphamide, Melphalan,
Chlorambucil, Busulfan, Thiotepa. Antimetabolites: Mercaptopurine*, Thioguanine, Fluorouracil,
Floxuridine, Cytarabine, Methotrexate*, Azathioprine. Antibiotics: Dactinomycin, Daunorubicin,
Doxorubicin, Bleomycin . Plant products: Etoposide, Vinblastin sulphate, Vincristin sulphate
Miscellaneous: Cisplatin, Mitotane.
UNIT – II 10 Hours
Anti-anginal:
Vasodilators: Amyl nitrite, Nitroglycerin*, Pentaerythritol tetranitrate, Isosorbide dinitrite*,
Dipyridamole.. Calcium channel blockers: Verapamil, Bepridil hydrochloride, Diltiazem
hydrochloride, Nifedipine, Amlodipine, Felodipine, Nicardipine, Nimodipine.
Diuretics: Carbonic anhydrase inhibitors: Acetazolamide*, Methazolamide,
Dichlorphenamide. Thiazides: Chlorthiazide*, Hydrochlorothiazide, Hydroflumethiazide, Cyclothiazide,
Loop diuretics: Furosemide*, Bumetanide, Ethacrynic acid. Potassium sparing Diuretics:
Spironolactone, Triamterene, Amiloride. Osmotic Diuretics: Mannitol
Anti-hypertensive Agents: Timolol, Captopril, Lisinopril, Enalapril, Benazepril hydrochloride,
Quinapril hydrochloride, Methyldopate hydrochloride,* Clonidine hydrochloride, Guanethidine
monosulphate, Guanabenz acetate, Sodium nitroprusside, Diazoxide, Minoxidil, Reserpine,
Hydralazine hydrochloride.
UNIT- III 10 Hours

Anti-arrhythmic Drugs: Quinidine sulphate, Procainamide hydrochloride, Disopyramide


phosphate*, Phenytoin sodium, Lidocaine hydrochloride, Tocainide hydrochloride, Mexiletine
hydrochloride, Lorcainide hydrochloride, Amiodarone, Sotalol.
Anti-hyperlipidemic agents: Clofibrate, Lovastatin, Cholesteramine and Cholestipol
Coagulant & Anticoagulants: Menadione, Acetomenadione, Warfarin*, Anisindione,
clopidogrel
Drugs used in Congestive Heart Failure: Digoxin, Digitoxin, Nesiritide, Bosentan, Tezosentan

UNIT- IV 08 Hours

Drugs acting on Endocrine system: Nomenclature, Stereochemistry and metabolism of steroids


Sex hormones: Testosterone, Nandralone, Progestrones, Oestriol, Oestradiol, Oestrione,
Diethyl stilbestrol.
Drugs for erectile dysfunction: Sildenafil, Tadalafil.
Oral contraceptives: Mifepristone, Norgestril, Levonorgestrol
Corticosteroids: Cortisone, Hydrocortisone, Prednisolone, Betamethasone, Dexamethasone
Thyroid and antithyroid drugs: L-Thyroxine, L-Thyronine, Propylthiouracil, Methimazole.

UNIT – V 07 Hours
Antidiabetic agents: Insulin and its preparations, Sulfonyl ureas: Tolbutamide*, Chlorpropamide,
Glipizide, Glimepiride. Biguanides: metformin. Thiazolidinediones: Pioglitazone, Rosiglitazone.
Meglitinides: Repaglinide, Nateglinide. Glucosidase inhibitors: Acrabose, Voglibose.
Local Anesthetics: SAR of Local anesthetics, Benzoic Acid derivatives; Cocaine, Hexylcaine,
Meprylcaine, Cyclomethycaine, Piperocaine., Amino Benzoic acid derivatives: Benzocaine*,
Butamben, Procaine*, Butacaine, Propoxycaine, Tetracaine, Benoxinate. Lidocaine/Anilide
derivatives: Lignocaine, Mepivacaine, Prilocaine, Etidocaine.
Miscellaneous: Phenacaine, Diperodon, Dibucaine.*

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. I.L. Finar. Organic Chemistry, Vol. II.
8. Lednicer. The Organic Chemistry of Drug Synthesis, Vol. 1to 5.
9. Indian Pharmacopoeia, GOI, 2007.
10. A.I.Vogel. Text book of practical organic chemistry-
BP 502 T. Industrial Pharmacy- I (Theory)
45 Hours
Scope: Course enables the student to understand and appreciate the influence of
pharmaceutical additives and various pharmaceutical dosage forms on the performance of
the drug product.

Objectives: Upon completion of the course the student shall be able to


1. Know the various pharmaceutical dosage forms and their manufacturing
techniques.
2. Know various considerations in development of pharmaceutical dosage forms.
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their
quality.

Course content:
3 hours/ week
UNIT-I 07 Hours
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant.
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.

UNIT-II 10 Hours
Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients,
Formulation of tablets, granulation methods, compression and processing problems.
Equipments and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests.

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs


suspensions and emulsions; Filling and packaging; evaluation of liquid orals
official in pharmacopoeia.
UNIT-III 08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. size
of capsules, Filling, finishing and special techniques of formulation of hard gelatin
capsules, manufacturing defects. In process and final product quality control tests
for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of
capsules,,importance of base adsorption and minim/gram factors, production, in
process and final product quality control tests. Packing, storage and stability testing
of soft gelatin capsules and their applications.
Pellets: Introduction, formulation requirements, pelletization process, equipments for
manufacture of pellets.

UNIT-IV 10 Hours
Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls, aseptic processing
c. Formulation of injections, sterile powders, large volume parenterals and
lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion
fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye
drops, eye ointments and eye lotions; methods of preparation; labeling, containers;
evaluation of ophthalmic preparations
UNIT-V 10 Hours
Cosmetics: Formulation and preparation of the following cosmetic preparations:
lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and
sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol
systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality
control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products,
factors influencing choice of containers, legal and official requirements for containers,
stability aspects of packaging materials, quality control tests.
BP 507P. Industrial Pharmacy- I (Practical)
4 Hours/week
1. Preformulation studies on paracetamol/aspirin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Quality control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold / vanishing cream)
11. Evaluation of Glass containers (as per IP)

Recommended Books: (Latest Editions)


1. H.A. Liberman, Leon Lachman & J.B.Schwartz. Pharmaceutical dosage forms - Tablets,
volume 1 -3.
2. Liberman & Lachman. Pharmaceutical dosage form - Parenteral medication vol-
1 & 2.
3. Liberman & Lachman. Pharmaceutical dosage form disperse system VOL-1.
4. Gilbert S. Banker & C.T. Rhodes. Modern Pharmaceutics, 3rd Edition.
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical
Science (RPS)
6. Liberman & Lachman. Theory and Practice of Industrial Pharmacy.
7. M.E Aulton. Pharmaceutics- The science of dosage form design, Churchill
livingstone, Latest edition.
8. H. C Ansel. Introduction to Pharmaceutical Dosage Forms, Lea & Febiger,
Philadelphia, 5thedition, 2005
9. Cartensen & C.J. Rhodes. Drug stability - Principles and practice, 3rd Edition,
Marcel Dekker Series, Vol 107.
10. Leon Shargel. Comprehensive Pharmacy Review.
BP503.T. PHARMACOLOGY-II (Theory)
45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on different systems of body and in addition,emphasis
on the basic concepts of bioassay.

Objectives: Upon completion of this course the student should be able to


1. Understand the mechanism of drug action and its relevance in the treatment of
different diseases
2. Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
3. Demonstrate the various receptor actions using isolated tissue preparation
4. Appreciate correlation of pharmacology with related medical sciences
Course Content:
UNIT-I 10hours
Pharmacology of drugs acting on cardio vascular system
a. Introduction to hemodynamic and electrophysiology of heart.
b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.

UNIT-II 10hours
Pharmacology of drugs acting on cardio vascular system
a. Drug used in the therapy of shock.
b. Hematinics, coagulants and anticoagulants.
c. Fibrinolytics and anti-platelet drugs
d. Plasma volume expanders
Pharmacology of drugs acting on urinary system
a. Diuretics
b. Anti-diuretics.

UNIT-III 10hours
Autocoids and related drugs
a. Introduction to autacoids and classification
b. Histamine, 5-HT and their antagonists.
c. Prostaglandins, Thromboxanes and Leukotrienes.
d. Angiotensin, Bradykinin and Substance P.
e. Non-steroidal anti-inflammatory agents
f. Anti-gout drugs
g. Antirheumatic drugs
UNIT-IV 08hours
Pharmacology of drugs acting on endocrine system
a. Basic concepts in endocrine pharmacology.
b. Anterior Pituitary hormones- analogues and their inhibitors.
c. Thyroid hormones- analogues and their inhibitors.
d. Hormones regulating plasma calcium level- Parathormone, Calcitonin and
Vitamin-D.
d. Insulin, Oral Hypoglycemic agents and glucagon.
e. ACTH and corticosteroids.

UNIT-V 07hours
Pharmacology of drugs acting on endocrine system
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
Bioassay
a. Principles and applications of bioassay.
b.Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH,d-tubocurarine,digitalis, histamine
and 5-HT
BP 508 P. PHARMACOLOGY-II (Practical)
4Hrs/Week

1. Introduction to in-vitro pharmacology and physiological salt solutions.


2. Effect of drugs on isolated frog heart.
3. Effect of drugs on blood pressure and heart rate of dog.
4. Study of diuretic activity of drugs using rats/mice.
5. DRC of acetylcholine using frog rectus abdominis muscle.
6. Effect of physostigmine and atropine on DRC of acetylcholine using frog rectus
abdominis muscle and rat ileum respectively.
7. Bioassay of histamine using guinea pig ileum by matching method.
8. Bioassay of oxytocin using rat uterine horn by interpolation method.
9. Bioassay of serotonin using rat fundus strip by three point bioassay.
10. Bioassay of acetylcholine using rat ileum/colon by four point bioassay.
11. Determination of PA2 value of prazosin using rat anococcygeus muscle (by
Schilds plot method).
12. Determination of PD2 value using guinea pig ileum.
13. Effect of spasmogens and spasmolytics using rabbit jejunum.
14. Anti-inflammatory activity of drugs using carrageenan induced paw-edema
model.
15. Analgesic activity of drug using central and peripheral methods

Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos

Recommended Books (Latest Editions)


1. H P Rang , M M Dale, J M Ritter, R J Flower, Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier.
2. B G Katzung, S B Masters, A J Trevor, Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics.
4. K. K Marry Anne, Y Lloyd Yee, K. A Brian, L.C Robbin, G. B Joseph, A Wayne.
Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott Williams &
Wilkins.
5. M J Mycek, S B Gelnet and M M Perper. Lippincott’s Illustrated Reviews-
Pharmacology.
6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. H L Sharma, K K Sharma, Principles of Pharmacology, Paras medical publisher.
8. R Charles. Craig & Robert Modern Pharmacology with clinical Applications.
9. M N Ghosh. Fundamentals of Experimental Pharmacology. Hilton &
Company, Kolkata.
10. S K Kulkarni. Handbook of experimental pharmacology. Vallabh Prakashan.
BP504 T. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)
45Hours
Scope: The main purpose of subject is to impart the students the knowledge of how the
secondary metabolites are produced in the crude drugs, how to isolate and identify and
produce them industrially. Also this subject involves the study of producing the plants and
phytochemicals through plant tissue culture, drug interactions and basic principles of
traditional system of medicine
Objectives: Upon completion of the course, the student shall be able
1. to know the modern extraction techniques, characterization and identification of the
herbal drugs and phytoconstituents
2. to understand the preparation and development of herbal formulation.
3. to understand the herbal drug interactions
4. to carryout isolation and identification of phytoconstituents

Course Content:
UNIT-I 7 Hours
Metabolic pathways in higher plants and their determination
a) Brief study of basic metabolic pathways and formation of different secondary metabolites
through these pathways- Shikimic acid pathway, Acetate pathways and Amino acid pathway.
b) Study of utilization of radioactive isotopes in the investigation of Biogenetic studies.

UNIT-II 14 Hours
General introduction, composition, chemistry & chemical classes, biosources, therapeutic
uses and commercial applications of following
secondary metabolites:

Alkaloids: Vinca, Rauwolfia, Belladonna, Opium,


Phenylpropanoids and Flavonoids: Lignans, Tea, Ruta
Steroids, Cardiac Glycosides & Triterpenoids: Liquorice, Dioscorea, Digitalis
Volatile oils: Mentha, Clove, Cinnamon, Fennel, Coriander,
Tannins: Catechu, Pterocarpus
Resins: Benzoin, Guggul, Ginger, Asafoetida, Myrrh, Colophony
Glycosides: Senna, Aloes, Bitter Almond
Iridoids, Other terpenoids & Naphthaquinones: Gentian, Artemisia, taxus, carotenoids
UNIT-III 06 Hours
Isolation, Identification and Analysis of Phytoconstituents
a) Terpenoids: Menthol, Citral, Artemisin
b) Glycosides: Glycyrhetinic acid & Rutin
c) Alkaloids: Atropine,Quinine,Reserpine,Caffeine
d) Resins: Podophyllotoxin, Curcumin

UNIT-IV 10 Hours
Industrial production, estimation and utilization of the following phytoconstituents:
Forskolin, Sennoside, Artemisinin, Diosgenin, Digoxin, Atropine, Podophyllotoxin, Caffeine,
Taxol, Vincristine and Vinblastine

UNIT V 8 Hours
Basics of Phytochemistry
Modern methods of extraction, application of latest techniques like Spectroscopy,
chromatography and electrophoresis in the isolation, purification and identification of crude
BP 509 P. PHARMACOGNOSY AND PHYTOCHEMISTRY II (Practical)
4 Hours/Week

1. Morphology, histology and powder characteristics & extraction & detection of:
Cinchona, Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
2. Exercise involving isolation & detection of active principles
a. Caffeine - from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents by TLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii)
Colophony (iv) Aloes (v) Myrrh

Recommended Books: (Latest Editions)


1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers &
Distribution, New Delhi.
3. C.K. Kokate, Purohit, Gokhlae. Text book of Pharmacognosy (2007), 37th Edition,
Nirali Prakashan, New Delhi.
4. R.D. Choudhary. Herbal drug industry (1996), Ist Edn, Eastern Publisher, New
Delhi.
5. Dr.SH.Ansari. Essentials of Pharmacognosy, , IInd edition, Birla publications, New
Delhi, 2007
6. H.Pande. Herbal Cosmetics, Asia Pacific Business press, Inc, New Delhi.
7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi,
2005.
8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.
9. James Bobbers, Marilyn KS, VE Tylor Pharmacognosy & Pharmacobiotechnology.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington’s Pharmaceutical sciences.
12. Vyas and Dixit. Text Book of Biotechnology.
13. R.C. Dubey. Text Book of Biotechnology.
BP 505 T. PHARMACEUTICAL JURISPRUDENCE (Theory)

45 Hours
Scope: This course is designed to impart basic knowledge on important
legislations related to the profession of pharmacy in India.
Objectives: Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and
marketing of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws.
3. The regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals.
4. The code of ethics during the pharmaceutical practice.
Course Content:
UNIT-I 10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945:
Objectives, Definitions, Legal definitions of schedules to the Act and Rules
Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under
license or permit. Offences and penalties.
Manufacture of drugs – Prohibition of manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs,
Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license.

UNIT-II 10 Hours
Drugs and Cosmetics Act, 1940 and its rules 1945.
Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA)
Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for
drugs and cosmetics, List of permitted colors. Offences and penalties.
Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs
Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing
authorities, controlling authorities, Drugs Inspectors

UNIT-III 10 Hours
 Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its
constitution and functions, Education Regulations, State and Joint state pharmacy
councils; constitution and functions, Registration of Pharmacists, Offences and
penalties
 Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing,
Manufacture Inbond and Outside bond, Export of alcoholic preparations,
Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary Preparations.
Offences and Penalties.
 Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives,
Definitions, Authorities and Officers, Constitution and Functions of narcotic &
Psychotropic Consultative Committee, National Fund for Controlling the Drug
Abuse, Prohibition, Control and Regulation, opium poppy cultivation and production
of poppy straw, manufacture, sale and export of opium, Offences and Penalties

UNIT-IV 08 Hours
 Study of Salient Features of Drugs and Magic Remedies Act and its
rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of
Exempted advertisements, Offences and Penalties.
 Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional
Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of
Animals, Performance of Experiments, Transfer and acquisition of animals for
experiment, Records, Power to suspend or revoke registration, Offences and Penalties
 National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)-
2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations,
Retail price and ceiling price of scheduled formulations, National List of Essential
Medicines (NLEM)

UNIT-V 07 Hours
 Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry
committee, Health survey and development committee, Hathi committee and
Mudaliar committee
 Code of Pharmaceutical ethics: Definition, Pharmacist in relation to his job, trade,
medical profession and his profession, Pharmacist’s oath
 Medical Termination of Pregnancy Act
 Right to Information Act
 Introduction to Intellectual Property Rights (IPR)

Recommended books: (Latest Edition)


1. B. Suresh. Forensic Pharmacy.
2. B.M. Mithal. Text book of Forensic Pharmacy.
3. M.L. Mehra. Hand book of drug law.
4. N.K. Jain. A text book of Forensic Pharmacy.
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
8. Drugs and Magic Remedies act by Govt. of India publication
9. Bare Acts of the said laws published by Government. Reference books (Theory)
10. B S Kuchekar. Pharmaceutical Jurisprudence.
BP 506 T. ENVIRNOMENTAL STUDIES (THEORY)

100 MARKS CREDIT-4

Unit I: Environment and Ecosystem


Introduction, Importanceand Scope of Environmental Studies
Components of Environment; Atmosphere, Hydrosphere, Lithosphere and Biosphere
Ecosystems: Concept, Structure and Function of an Ecosystem; Energy Flow, Food Chains, Food
Webs, Ecological Pyramids, Ecological Niche and Keystone Species.

Unit II: Resources and Conservation


Introduction and Classification of Resources
ProblemsAssociated with Resources and Conservation; Forest resources, Water Resources, Energy
Resources, Land Resources
Biodiversity: Introduction, Issues and Conservation

Unit III: Environmental Pollutionand Issues


Introduction to Environmental Pollution
Causes, Effects and Control Measures of: Air Pollution, Water Pollution, Soil Pollution, Noise
Pollution, Nuclear Pollution
Environmental Issues; Climate Change, Global Warming, Acid Rain, Ozone Layer
Depletion etc. Firecracker and Associated Issues

Unit IV: Human and Environment


Human-Environment Relationship, Sustainable Development: Concept and Issues
Role of Information Technology in Environmental Management
Solid Waste Management
Environmental Refugees
Environmental Ethics: Issues and possible solutions
SEMESTER VI
BP601T. MEDICINAL CHEMISTRY – III (Theory)
45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure,
chemistry and therapeutic value of drugs. The subject emphasis on modern techniques of
rational drug design like quantitative structure activity relationship (QSAR), Prodrug
concept, combinatorial chemistry and Computer aided drug design (CADD). The subject
also emphasizes on the chemistry, mechanism of action, metabolism, adverse effects,
Structure Activity Relationships (SAR), therapeutic uses and synthesis of important
drugs.

Objectives: Upon completion of the course student shall be able to


1. Understand the importance of drug design and different techniques of drug
design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
Course Content:

Study of the development of the following classes of drugs, Classification, mechanism of


action, uses of drugs mentioned in the course, Structure activity relationship of selective
class of drugs as specified in the course and synthesis of drugs superscripted by (*)

UNIT – I 10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship,
Chemical degradation classification and important products of the following
classes.
β-Lactam antibiotics: Penicillin, Cepholosporins, β- Lactamase inhibitors,
Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline,Oxytetracycline, Chlortetracycline, Minocycline,
Doxycycline

UNIT – II 10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship,
Chemical degradation classification and important products of the following classes.
Macrolide: Erythromycin Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol*, Clindamycin.
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarials: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine,
Primaquine phosphate, Pamaquine*, Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunete, Artemether, Atovoquone
UNIT – III 10 Hours
Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniozid*, Ethionamide, Ethambutol,
Pyrazinamide, Para amino salicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine
Streptomycine, Capreomycin sulphate.
Urinary tract anti-infective agents
Quinolones: SAR of quinolones, Nalidixic Acid,Norfloxacin, Enoxacin,
Ciprofloxacin*, Ofloxacin, Lomefloxacin, Sparfloxacin, Gatifloxacin,
Moxifloxacin
Miscellaneous: Furazolidine, Nitrofurantoin*, Methanamine.
Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride,
Acyclovir*, Gancyclovir, Zidovudine, Didanosine, Zalcitabine, Lamivudine,
Loviride, Delavirding, Ribavirin, Saquinavir, Indinavir, Ritonavir.

UNIT – IV 08 Hours
Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole, Oxiconazole
Tioconozole, Miconazole*, Ketoconazole, Terconazole, Itraconazole, Fluconazole,
Naftifine hydrochloride, Tolnaftate*.
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide,
Iodoquinol, Pentamidine Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*,
Albendazole, Niclosamide, Oxamniquine, Praziquantal, Ivermectin.
Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethizine, Sulfacetamide*, Sulphapyridine,
Sulfamethoxaole*, Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.

UNIT – V 07 Hours
Introduction to Drug Design
Various approaches used in drug design.
Physicochemical parameters used in quantitative structure activity
relationship (QSAR) such as partition coefficient, Hammet’s electronic
parameter, Tafts steric parameter and Hansch analysis.
Pharmacophore modeling and docking techniques.

Combinatorial Chemistry: Concept and applications of combinatorial


chemistry: solid phase and solution phase synthesis.
BP 608 P. MEDICINAL CHEMISTRY- III (Practical)
4 Hours / week

I Preparation of drugs and intermediates


1 Sulphanilamide
2 7-Hydroxy, 4-methyl coumarin
3 Chlorobutanol
4 Triphenyl imidazole
5 Tolbutamide
6 Hexamine

II Assay of drugs
1 Isonicotinic acid hydrazide
2 Chloroquine
3 Metronidazole
4 Dapsone
5 Chlorpheniramine maleate
6 Benzyl penicillin

III Preparation of medicinally important compounds or intermediates by Microwave


irradiation technique

IV Drawing structures and reactions using chem draw®

V Determination of physicochemical properties such as logP, clogP, MR, Molecular


weight, Hydrogen bond donors and acceptors for class of drugs course content
using drug design software Drug likeliness screening (Lipinskies RO5)

Recommended Books (Latest Editions)


1. Wilson and Giswold’s Organic medicinal and Pharmaceutical Chemistry.
2. Foye’s Principles of Medicinal Chemistry.
3. Burger’s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington’s Pharmaceutical Sciences.
6. Martindale’s extra pharmacopoeia.
7. I.L. Finar. Organic Chemistry, Vol. II.
8. Lednicer. The Organic Chemistry of Drug Synthesis, Vol. 1-5.
9. Indian Pharmacopoeia, GOI, 2007.
10. A.I.Vogel. Text book of practical organic chemistry.
BP602 T. PHARMACOLOGY-III (Theory)
45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects
(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system, infectious diseases,
immuno-pharmacology and in addition,emphasis on the principles of toxicology and
chronopharmacology.

Objectives: Upon completion of this course the student should be able to:
1. understand the mechanism of drug action and its relevance in the treatment of different infectious
diseases
2. comprehend the principles of toxicology and treatment of various poisoningsand
3. appreciate correlation of pharmacology with related medical sciences.
Course Content:

UNIT-I 10hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
d. Nasal decongestants
e. Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract


a. Antiulcer agents.
b. Drugs for constipation and diarrhoea.
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.

UNIT-II 10hours
3. Chemotherapy
a. General principles of chemotherapy.
b. Sulfonamides and cotrimoxazole.
c. Antibiotics- Penicillins, cephalosporins, chloramphenicol, macrolides, quinolones and
fluoroquinolins, tetracycline and aminoglycosides
UNIT-III 10hours
3. Chemotherapy
a. Antitubercular agents
b. Antileprotic agents
c. Antifungal agents d. Antiviral
drugs e.Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
UNIT-IV 08hours
3. Chemotherapy
l. Urinary tract infections and sexually transmitted diseases. m.
Chemotherapy of malignancy.
4. Immunopharmacology
a. Immunostimulants
b. Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

UNIT-V 07hours
5. Principles of toxicology

a. Definition and basic knowledge of acute, subacute and chronic toxicity.


b. Definition and basic knowledge of genotoxicity, carcinogenicity, teratogenicity and mutagenicit
y
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine, organophosphosphorus
compound and lead, mercury and arsenic poisoning.

6. Chronopharmacology
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy.
BP 609 P. PHARMACOLOGY-III (Practical)
4Hrs/Week

1. Dose calculation in pharmacological experiments


2. Antiallergic activity by mast cell stabilization assay
3. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and
NSAIDS induced ulcer model.
4. Study of effect of drugs on gastrointestinal motility
5. Effect of agonist and antagonists on guinea pig ileum
6. Estimation of serum biochemical parameters by using semi- autoanalyser
7. Effect of saline purgative on frog intestine
8. Insulin hypoglycemic effect in rabbit
9. Test for pyrogens ( rabbit method)
10. Determination of acute oral toxicity (LD50) of a drug from a given data
11. Determination of acute skin irritation / corrosion of a test substance
12. Determination of acute eye irritation / corrosion of a test substance
13. Calculation of pharmacokinetic parameters from a given data
14. Biostatistics methods in experimental pharmacology( student’s t test, ANOVA)
15. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon
Signed Rank test)

*Experiments are demonstrated by simulated experiments/videos

Recommended Books (Latest Editions)


1 . H P Rang , M M Dale, J M Ritter, R J Flower, Rang and Dale’s Pharmacology,
Churchil Livingstone Elsevier.
2. B G Katzung, S B Masters, A J Trevor, Basic and clinical pharmacology, Tata Mc
Graw-Hill.
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics.
4. K. K Marry Anne, Y Lloyd Yee, K. A Brian, L.C Robbin, G. B Joseph, A Wayne.
Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott Williams &
Wilkins.
5. M J Mycek, S B Gelnet and M M Perper. Lippincott’s Illustrated Reviews-
Pharmacology.
6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical
Publishers (P) Ltd, New Delhi.
7. H L Sharma, K K Sharma, Principles of Pharmacology, Paras medical publisher.
8. R Charles. Craig & Robert Modern Pharmacology with clinical Applications.
9. M N Ghosh. Fundamentals of Experimental Pharmacology. Hilton &
Company, Kolkata.
10. S K Kulkarni. Handbook of experimental pharmacology. Vallabh Prakashan.
BP 603 T. HERBAL DRUG TECHNOLOGY (Theory)
45 hours
Scope: This subject gives the student the knowledge of basic understanding of herbal drug
industry, the quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics,
natural sweeteners, nutraceutical etc. The subject also emphasizes on Good Manufacturing
Practices (GMP), patenting and regulatory issues of herbal drugs

Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug
product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .

Course content:
UNIT-I 11 Hours
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation
Source of Herbs
Selection, identification and authentication of herbal materials
Processing of herbal raw material

Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming.
Pest and Pest management in medicinal plants: Biopesticides/Bioinsecticides.

Indian Systems of Medicine


a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz Aristas and Asawas,
Ghutika,Churna, Lehya and Bhasma.

UNIT-II 7 Hours
Nutraceuticals
General aspects, Market, growth, scope and types of products available in the market. Health
benefits and role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable
bowel syndrome and various Gastro intestinal diseases.
Study of following herbs as health food: Alfaalfa, Chicory, Ginger, Fenugreek, Garlic,
Honey, Amla, Ginseng, Ashwagandha, Spirulina

Herbal-Drug and Herb-Food Interactions: General introduction to interaction and


classification. Study of following drugs and their possible side effects and interactions:
Hypercium, kava-kava, Ginkobiloba, Ginseng, Garlic, Pepper & Ephedra.

UNIT-III 10 Hours
Herbal Cosmetics
Sources and description of raw materials of herbal origin used via, fixed oils, waxes, gums
colours, perfumes, protective agents, bleaching agents, antioxidants in products such as skin
care, hair care and oral hygiene products.

Herbal excipients:
Herbal Excipients – Significance of substances of natural origin as excipients – colorants,
sweeteners, binders, diluents, viscosity builders, disintegrants, flavors & perfumes.

Herbal formulations :
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms
like phytosomes

UNIT- IV 10 Hours
Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal drugs
Stability testing of herbal drugs.

Patenting and Regulatory requirements of natural products:


a) Definition of the terms: Patent, IPR, Farmers right, Breeder’s right, Bioprospecting and
Biopiracy
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma
& Neem.

Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of


manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.

UNIT-V 07 Hours
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and
aromatic plants in India.

Schedule T – Good Manufacturing Practice of Indian systems of medicine


Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
BP 610 P. HERBAL DRUG TECHNOLOGY (Practical)
4 hours/ week

1. To perform preliminary phytochemical screening of crude drugs.


2. Determination of the alcohol content of Asava and Arista
3. Evaluation of excipients of natural origin
4. Incorporation of prepared and standardized extract in cosmetic formulations like creams,
lotions and shampoos and their evaluation.
5. Incorporation of prepared and standardized extract in formulations like syrups, mixtures
and tablets and their evaluation as per Pharmacopoeial requirements.
6. Monograph analysis of herbal drugs from recent Pharmacopoeias
7. Determination of Aldehyde content
8. Determination of Phenol content
9. Determination of total alkaloids

Recommended Books: (Latest Editions)

1. Trease & Evans. Textbook of Pharmacognosy.


2. Tyler, Brady & Robber. Textbook of Pharmacognosy.
3. Kokate, Purohit and Gokhale. Pharmacognosy.
4. Dr.S.H.Ansari. Essential of Pharmacognosy
5. V.D.Rangari. Pharmacognosy & Phytochemistry.
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in
Indian Medicine & Homeopathy)
7. P Mukherjee, Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
8. S S Agarwal and N Paridhabi. Herbal Drug Technology.

9. A N Kalia. Industrial Pharmacognosy.

10. R.D Choudary. 1996. Herbal Drugs Industry. New Delhi: Eastern Publisher.
BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS
(Theory)
45 Hours
Scope: This subject is designed to impart knowledge and skills of Biopharmaceutics
and pharmacokinetics and their applications in pharmaceutical development, design of
dose and dosage regimen and in solving the problems arised therein.
Objectives: Upon completion of the course student shall be able to:
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and
their significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic
parameters to describe the kinetics of drug absorption, distribution,
metabolism, excretion, elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug
products and their significance.
4. Understand various pharmacokinetic parameters, their significance & applications.

Course Content:
UNIT-I 10 Hours
Introduction to Biopharmaceutics
Absorption: Mechanisms of drug absorption through GIT, factors influencing drug
absorption though GIT, absorption of drug from Non per oral extra-vascular
routes.
Distribution: Tissue permeability of drugs, binding of drugs, apparent, volume of
drug distribution, plasma and tissue protein binding of drugs, factors affecting
protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs
UNIT- II 10 Hours
Elimination: Drug metabolism and basic understanding metabolic pathways renal
excretion of drugs, factors affecting renal excretion of drugs, renal clearance, Non renal
routes of drug excretion of drugs.
Bioavailability and Bioequivalence: Definition and Objectives of bioavailability,
absolute and relative bioavailability, measurement of bioavailability, in-vitro drug
dissolution models, in-vitro-in-vivo correlations, bioequivalence studies, methods to
enhance the dissolution rates and bioavailability of poorly soluble drugs.
UNIT- III 10 Hours
Pharmacokinetics: Definition and introduction to Pharmacokinetics, Compartment
models, Non compartment models, physiological models, One compartment open
model. (a). Intravenous Injection (Bolus) (b). Intravenous infusion and (c) Extra
vascular administrations. Pharmacokinetics parameters - KE ,t1/2,Vd,AUC,Ka, Clt and
CLR- definitions methods of eliminations, understanding of their significance and
application
UNIT- IV 08 Hours
Multi compartment models: Two compartment open model. IV bolus.
Kinetics of multiple dosing, steady state drug levels, calculation of loading and
maintenance doses and their significance in clinical settings.

UNIT- V 07 Hours
Nonlinear Pharmacokinetics: a. Introduction, b. Factors causing Non-linearity.
c. Michaelis-Menten method of estimating parameters, Explanation with example of
drugs.

Recommended Books: (Latest Editions)


1. Milo Gibaldi. Biopharmaceutics and Clinical Pharmacokinetics.
2. Robert F Notari. Biopharmaceutics and Pharmacokinetics.
3. Leon Shargel and B C Andrew Applied biopharmaceutics and pharmacokinetics,
.YU 4th edition,Prentice-Hall Inernational edition.USA
4. D. M. Brahmankar and Sunil B. Jaiswal Bio pharmaceutics and Pharmacokinetics-
A Treatise, ,Vallabh Prakashan Pitampura, Delhi
5. Milo Glbaldi Donald, R. Mercel Pharmacokinetics: Dekker Inc.
6. Milo Gibaldi and Laurie Prescott. Hand Book of Clinical Pharmacokinetics, by
ADIS Health Science Press.
7. Swarbrick Biopharmaceutics.
8. Malcolm Rowland. Clinical Pharmacokinetics, Concepts and Applications.
9. F Abdou, H.M Mack. Dissolution, Bioavailability and Bioequivalence, Publishing
Company, Pennsylvania 1989.
10. Rebort F Notari. Biopharmaceutics and Clinical Pharmacokinetics-An
introduction 4th edition Revised and expanded Marcel Dekker Inn, New York
and Basel, 1987.
11. Remington’s Pharmaceutical Sciences, By Mack Publishing Company,
Pennsylvnia.
BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory)
45 Hours
Scope:
 Biotechnology has a long promise to revolutionize the biological sciences and
technology.
 Scientific application of biotechnology in the field of genetic engineering,
medicine and fermentation technology makes the subject interesting.
 Biotechnology is leading to new biological revolutions in diagnosis, prevention
and cure of diseases, new and cheaper pharmaceutical drugs.
 Biotechnology has already produced transgenic crops and animals and the future
promises lot more.
 It is basically a research-based subject.
Objectives: Upon completion of the subject student shall be able to;
1. Understanding the importance of Immobilized enzymes in Pharmaceutical
Industries
2. Genetic engineering applications in relation to production of pharmaceuticals
3. Importance of Monoclonal antibodies in Industries
4. Appreciate the use of microorganisms in fermentation technology

Unit I 10 Hours
a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d) Brief introduction to Protein Engineering.
e) Use of microbes in industry. Production of Enzymes- General consideration -
Amylase, Catalase, Peroxidase, Lipase, Protease, Penicillinase.
f) Basic principles of genetic engineering.

Unit II 10 Hours
a) Study of cloning vectors, restriction endonucleases and DNA ligase.
b) Recombinant DNA technology. Application of genetic engineering in medicine.
c) Application of r DNA technology and genetic engineering in the production of:
i) Interferon ii) Vaccines- hepatitis- B iii) Hormones-Insulin.
d) Brief introduction to PCR
Unit III 10 Hours
Types of immunity- humoral immunity, cellular immunity
a) Structure of Immunoglobulins
b) Structure and Function of MHC
c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.
d) General method of the preparation of bacterial vaccines, toxoids, viral vaccine,
antitoxins, serum-immune blood derivatives and other products relative to immunity.
e) Storage conditions and stability of official vaccines
f) Hybridoma technology- Production, Purification and Applications
g) Blood products and Plasma Substituties.
Unit IV
08Hours

a) Immuno blotting techniques- ELISA, Western blotting, Southern


blotting. b) Genetic organization of Eukaryotes and Prokaryotes
c) Microbial genetics including transformation, transduction, conjugation,
plasmids and transposons.
d) Introduction to Microbial biotransformation and applications.
e) Mutation: Types of mutation/mutants.

Unit V 07
Hours
a) Fermentation methods and general requirements, study of media,
equipments, sterilization methods, aeration process, stirring.
b) Large scale production fermenter design and its various controls.
c) Study of the production of - penicillins, citric acid, Vitamin B12,
Glutamic acid, Griseofulvin,
d) Blood Products: Collection, Processing and Storage of whole human
blood, dried human plasma, plasma Substituties.

Recommended Books (Latest edition):


1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and
Applications of RecombinantDNA: ASM Press Washington D.C.
2. RA Goldshy et. al., : Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by
Royal Society of Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell
Scientific
Publication.
7. F P Stanbury, A Whitakar, and J S Hall, Principles of fermentation
technology,
2nd edition, Aditya books Ltd., New Delhi
8. A Sharma. Plant Chromosome analysis, manipulation and engineering. Harwood
Academic
Publishers.
9. S P Vyas,V K Dixit. Pharmaceutical biotechnology. CBS Publishers and
distributors, 2001
10. Murray Moo-Young, M.M. Comprehensive Biotechnology. Pergamon Press Ltd.
BP 606 T:PHARMACEUTICAL QUALITY ASSURANCE (Theory)
45 Hours
Scope: This course deals with the various aspects of quality control
and quality assurance aspects of pharmaceutical industries. It deals with the
important aspects like cGMP, QC tests, documentation, quality certifications
and regulatory affairs.
Objectives: Upon completion of the course student shall
be able to:
 understand the cGMP aspects in a pharmaceutical industry
 appreciate the importance of documentation
 understand the scope of quality certifications applicable to
pharmaceutical industries
 understand the responsibilities of QA & QC departments
Course content:
UNIT – I 10 Hours
Quality Assurance and Quality Management concepts: Definition and concept
of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview
of QSEM, with special emphasis on Q-series guidelines, ICH stability testing
guidelines
Quality by design (QbD): Definition, overview, elements of QbD
program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements,
steps for registration NABL accreditation : Principles and procedures

UNIT - II
10 Hours Organization and personnel: Personnel responsibilities, training, hygiene
and personal records. Premises: Design, construction and plant layout,
maintenance, sanitation, environmental control, utilities and maintenance of sterile
areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications,
maintenance, purchase specifications and maintenance of stores for raw materials.

UNIT – III
10 Hours
Quality Control: Quality control test for containers, rubber closures and secondary
packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel,
Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol
for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification
of Testing Facilities
UNIT – IV
08 Hours Complaints: Complaints and evaluation of complaints, Handling of
return good, recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record,
Master Formula Record, SOP, Quality audit, Quality Review and Quality
documentation, Reports and documents, distribution records.

UNIT – V
07 Hours Calibration and Validation: Introduction, definition and general
principles of calibration, qualification and validation, importance and scope of
validation, types of validation, validation master plan. Calibration of pH meter,
Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.
Warehousing: Good warehousing practice, materials management

Recommended Books: (Latest Edition)


1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines
and Related materials Vol I WHO Publications.
4. Kushik Maitra and Sedhan K Ghosh. A guide to Total Quality Management.
5. P P Sharma. How to Practice GMP’s.
6. Sadhank G Ghosh. ISO 9000 and Total Quality Management.
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods
of Analysis and Quality specification for Pharmaceutical Substances,
Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines
BP 607 T: EASTERN HIMALAYAN STUDIES (Theory)
100 MARKS CREDIT-4

Unit I: Geography and Environment of the Eastern Himalayas [Sikkim, Darjeeling,


Bhutan, Arunachal Pradesh]
Delineation of the Eastern Himalaya as a region
Physiography; Climate; Drainage; Biodiversity and overview of Natural Resources
Unit II: Historical background
Brief History of Sikkim and Darjeeling
Spatial relations (Trade and Religious linkages) of Sikkim with its Neighbours- Tibet, Bhutan and
Nepal.

Unit III: Society, Economy and Polity


Society and Culture in Sikkim;
Economy and Livelihood in Sikkim with emphasis on Agriculture, Industry and
Tourism; Social and Political dimensions of Sikkim and Darjeeling Himalaya

Unit IV: Critical Environmental Issues


Development Bottlenecks: Potentials, Prospects and Implications with special reference to
Hydro- resources, Communication and Industrial Development.
Climate Change, Natural Hazards and Disaster Management, Degradation of Bio-Resources

Essential Readings:
1. Bose, S.C (1968). Land and people of the Himalaya. Indian Publications, Calcutta.
2. Karan, P.P and Jenkins, W.M (1963). The Himalayan Kingdoms. Princeton
3.Risley, H.H., The Gazetteer of Sikhim(1989), B.R. Publishing Corporation
4. Rustumji, N (1971). Enchanted Frontiers: Sikkim, Bhutan and India’s North-Eastern
Borderland. Bombay: Oxford University Press.
5. Sarkar, RL and Mahendra P Lama (ed.1986). The Eastern Himalayas: Environment and
Economy, Atma Ram, New Delhi.
6.Waddell, L.A (1979). Among the Himalayas. New Delhi: Mittal Publication

Suggested Readings and Documentaries


1. Bulletin of Tibetology, Namgyal Institute of Tibetology
2. Denjongpa, Anna Balikci and Mckay, Alex (2011), Buddhist Himalaya: studies in
Religion, History and Culture, Volume II: The Sikkim Papers
3. Grazing on the Border: the Yak Herders of North Sikkim, (2017) ,Namgyal Institute of
Tibetology
4. Mullard, S.(2009) Opening of the Hidden, Land: State Formation and Construction of
Sikkimese History, University of Oxford
5. Pang Lhabsol: Sikkim’s national Ritual of the Land and its Guardian Deities, (2015),
Namgyal Institute of Tibetology
6. Satyajit(1971), Sikkim
7. Tingvong: A Lepcha Village, (2005), Namgyal Institute of Tibetology
SEMESTER VII
BP701T. INSTRUMENTAL METHODS OF ANALYSIS (Theory)
45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental
knowledge on the principles and instrumentation of spectroscopic and chromatographic
technique. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to


1. Understand the interaction of matter with electromagnetic radiations and its
applications in drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.
Course Content:
UNIT –I 10 Hours
UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on
absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-
Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component
analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external
conversions, factors affecting fluorescence, quenching, instrumentation and
applications

UNIT –II 10 Hours


IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample handling,
factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Flame Photometry-Principle, interferences, instrumentation and applications
Atomic absorption spectroscopy- Principle, interferences, instrumentation and
applications
Nepheloturbidometry- Principle, instrumentation and applications

UNIT –III 10 Hours


Introduction to chromatography
Adsorption and partition column chromatography-Methodology, advantages,
disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf values,
advantages, disadvantages and applications.
Paper chromatography-Introduction, methodology, development techniques,
advantages, disadvantages and applications
Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques
of paper, gel, capillary electrophoresis, applications

UNIT –IV 08 Hours

Gas chromatography - Introduction, theory, instrumentation, derivatization,


temperature programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC)-Introduction, theory,
instrumentation, advantages and applications.

UNIT –V 07 Hours

Ion exchange chromatography- Introduction, classification, ion exchange resins,


properties, mechanism of ion exchange process, factors affecting ion exchange,
methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications
BP705P. INSTRUMENTAL METHODS OF ANALYSIS (Practical)
4 Hours/Week
1 Determination of absorption maxima and effect of solvents on absorption
maxima of organic compounds
2 Estimation of dextrose by colorimetry
3 Estimation of sulfanilamide by colorimetry
4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5 Assay of paracetamol by UV- Spectrophotometry
6 Estimation of quinine sulfate by fluorimetry
7 Study of quenching of fluorescence
8 Determination of sodium by flame photometry
9 Determination of potassium by flame photometry
10 Determination of chlorides and sulphates by nephelo turbidometry
11 Separation of amino acids by paper chromatography
12 Separation of sugars by thin layer chromatography
13 Separation of plant pigments by column chromatography
14 Demonstration experiment on HPLC
15 Demonstration experiment on Gas Chromatography

Recommended Books (Latest Editions)


1. B.K Sharma. Instrumental Methods of Chemical Analysis.
2. Y.R Sharma. Organic spectroscopy.
3. Kenneth A. Connors. Text book of Pharmaceutical Analysis.
4. A.I. Vogel. Vogel’s Text book of Quantitative Chemical Analysis.
5. A.H. Beckett and J.B. Stenlake. Practical Pharmaceutical Chemistry.
6. I. L. Finar. Organic Chemistry.
7. William Kemp. Organic spectroscopy.
8. D. C. Garrett. Quantitative Analysis of Drugs.
9. P. D. Sethi. Quantitative Analysis of Drugs in Pharmaceutical Formulations.
10. Silverstein. Spectrophotometric identification of Organic Compounds.
BP 702 T. INDUSTRIAL PHARMACY -II (Theory)
45 Hours
Scope: This course is designed to impart fundamental knowledge on pharmaceutical
product development and translation from laboratory to market
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Content:

UNIT-I 10 Hours
Pilot plant scale up techniques: General considerations - including significance of
personnel requirements, space requirements, raw materials, Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC
guidelines, Introduction to platform technology

UNIT-II 10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer(TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from R
& D to production (Process, packaging and cleaning), Granularit y of TT Process (API,
excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, Commercialization - practical aspects and
problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs,
legal issues

UNIT-III 10 Hours
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulator y
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical
Drug Development, Pharmacology, Drug Metabolism and Toxicology, General
considerations of Investigational New Drug (IND) Application, Investigator’s Brochure
(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for
FDA Submissions, Management of Clinical Studies.
UNIT-IV 08 Hours
Quality management systems: Quality management & Certifications: Concept of
Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out
of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality
systems standards, ISO 14000, NABL, GLP
UNIT-V 07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization
(CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of
Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for
New Drugs.

Recommended Books: (Latest Editions)


1. H.A. Liberman, Leon Lachman & J.B.Schwartz. Pharmaceutical dosage forms - Tablets,
volume 1 -3.
2. Liberman & Lachman Pharmaceutical dosage form - Parenteral medication vol- 1
& 2.
3. Liberman & Lachman Pharmaceutical dosage form disperse system VOL-1.
4. Gilbert S. Banker & C.T. Rhodes. Modern Pharmaceutics, 3rd Edition.
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical
Science (RPS)
6. Liberman & Lachman. Theory and Practice of Industrial Pharmacy.
7. M.E. Aulton. Pharmaceutics- The science of dosage form design, Churchill
livingstone, Latest edition.
8. H. C. Ansel. Introduction to Pharmaceutical Dosage Forms, Lea &Febiger,
Philadelphia, 5thedition, 2005
9. Cartensen & C.J. Rhodes. Drug stability - Principles and practice, 3rd Edition,
Marcel Dekker Series, Vol 107.
10. Leon Shargel. Comprehensive Pharmacy Review.
BP 703T. PHARMACY PRACTICE (Theory)

45 Hours

Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In
community pharmacy, students will be learning various skills such as dispensing of
drugs, responding to minor ailments by providing suitable safe medication, patient
counselling for improved patient care in the community set up.

Objectives: Upon completion of the course, the student shall be able to

1. know various drug distribution methods in a hospital


2. appreciate the pharmacy stores management and inventory control
3. monitor drug therapy of patient through medication chart review and clinical
review
4. obtain medication history interview and counsel the patients
5. identify drug related problems
6. detect and assess adverse drug reactions
7. interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. know pharmaceutical care services
9. do patient counseling in community pharmacy;
10. appreciate the concept of Rational drug therapy.

Unit I: 10 Hours
a) Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a
Hospital, and Medical staffs involved in the hospital and their functions.

b) Hospital pharmacy and its organization

Definition, functions of hospital pharmacy, Organization structure, Location, Layout


and staff requirements, and Responsibilities and functions of hospital pharmacists.

c) Adverse drug reaction


Classifications - Excessive pharmacological effects, secondary pharmacological
effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity
following sudden withdrawal of drugs, Drug interaction- beneficial interactions,
adverse interactions, and pharmacokinetic drug interactions, Methods for detecting
drug interactions, spontaneous case reports and record linkage studies, and Adverse
drug reaction reporting and management.

d) Community Pharmacy
Organization and structure of retail and wholesale drug store, t ypes and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of
proprietary products, maintenance of records of retail and wholesale drug store.

Unit II: 10 Hours


a) Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy
and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs.

b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from hospital
formulary.

c) Therapeutic drug monitoring


Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.

d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.

e) Patient medication history interview


Need for the patient medication history interview, medication interview forms.

f) Community pharmacy management


Financial, materials, staff, and infrastructure requirements.

Unit III: 10 Hours


a) Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in
including drugs into formulary, inpatient and outpatient prescription, automatic stop
order, and emergency drug list preparation.

b) Drug information services


Drug and Poison information centre, Sources of drug information, Computerised
services, and storage and retrieval of information.

c) Patient
counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist

d) Education and training program in the hospital


Role of pharmacist in the education and training program, Internal and external
training program, Services to the nursing homes/clinics, Code of ethics for community
pharmacy, and Role of pharmacist in the interdepartmental communication and
community health education.

e) Prescribed medication order and communication skills


Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.

Unit IV 8 Hours
a) Budget preparation and implementation
Budget preparation and implementation

b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review, pharmacist intervention, Ward round participation, Medication
history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.

c) Over the counter (OTC) sales


Introduction and sale of over the counter, and Rational use of common over the
counter medications.

Unit V 7 Hours
a) Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase
and inventory control: principles, purchase procedure, purchase order, procurement
and stocking, Economic order quantity, Reorder quantity level, and Methods used for
the analysis of the drug expenditure

b) Investigational use of drugs


Description, principles involved, classification, control, identification, role of hospital
pharmacist, advisory committee.

c) Interpretation of Clinical Laboratory Tests


Blood chemistry, hematology, and urinalysis

Recommended Books (Latest Edition):

1. S H Merchant and J.S.Quadry. A textbook of hospital pharmacy, 4th ed.


Ahmadabad: B.S. Shah Prakakshan; 2001.
2. G Parthasarathi, Karin Nyfort-Hansen, Milap C Nahata. A textbook of Clinical
Pharmacy Practice- essential concepts and skills, 1st ed. Chennai: Orient
Longman Private Limited; 2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger;
1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
5. L T Scott. Basic skills in interpreting laboratory data, 4thed. American Society
of Health System Pharmacists Inc; 2009.
6. N S Parmar. Health Education and Community Pharmacy, 18th ed. India:
CBS Publishers & Distributers; 2008.

Journals:

1. Therapeutic drug monitoring. ISSN: 0163-4356


2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900 (online)
4. Pharmacy times (Monthly magazine)
BP 704T: NOVEL DRUG DELIVERY SYSTEMS (Theory)
45 Hours
Scope: This subject is designed to impart basic knowledge on the area of novel drug
delivery systems.
Objectives: Upon completion of the course student shall be able
1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development of
Novel drug delivery systems, their formulation and evaluation
Course content:
Unit-I 10 Hours
Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug candidates.Approaches to design controlled
release formulations based on diffusion, dissolution and ion exchange principles.
Physicochemical and biological properties of drugs relevant to controlled release
formulations
Polymers: Introduction, classification, properties, advantages and application of
polymers in formulation of controlled release drug delivery systems.
Unit-II 10 Hours
Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion /
mucoadhesion, concepts, advantages and disadvantages, transmucosal permeability and
formulation considerations of buccal delivery systems
Implantable Drug Delivery Systems:Introduction, advantages and disadvantages,
concept of implantsand osmotic pump
Unit-III 10 Hours
Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors
affecting permeation, permeation enhancers, basic components of TDDS, formulation
approaches
Gastroretentive drug delivery systems: Introduction, advantages, disadvantages,
approaches for GRDDS – Floating, high density systems, inflatable and gastroadhesive
systems and their applications
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of
drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays,
nebulizers
Unit-IV 08 Hours
Targeted drug Delivery: Concepts and approaches advantages and disadvantages,
introduction to liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications

Unit-V 07 Hours
Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to
overcome –Preliminary study, ocular formulations and ocuserts
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages,
development of intra uterine devices (IUDs) and applications

Recommended Books: (Latest Editions)


1. Y W. Chien, Novel Drug Delivery Systems, 2nd edition, revised and expanded, Marcel
Dekker, Inc., New York, 1992.
2. J R Robinson, V H I Lee, Controlled Drug Delivery Systems, Marcel Dekker, Inc., New
York, 1992.
3. Encyclopedia of Controlled Delivery. Edith Mathiowitz, Published by Wiley
Interscience Publication, John Wiley and Sons, Inc, New York. Chichester/Weinheim
4. N.K. Jain, Controlled and Novel Drug Delivery, CBS Publishers & Distributors, New
Delhi, First edition 1997 (reprint in 2001).
5. S.P. Vyas and R.K. Khar, Controlled Drug Delivery -concepts and advances,
Vallabh Prakashan, New Delhi, First edition 2002.
Journals
1. Indian Journal of Pharmaceutical Sciences (IPA)
2. Indian Drugs (IDMA)
3. Journal of Controlled Release (Elsevier Sciences)
4. Drug Development and Industrial Pharmacy (Marcel & Decker)
5. International Journal of Pharmaceutics (Elsevier Sciences)
BP 706PS: PRACTICE SCHOOL

6 Credit

In the VII semester, every candidate shall undergo practice school for a period of 150
hours evenly distributed throughout the semester. The student shall opt any one of the
domains for practice school declared by the program committee from time to time.
At the end of the practice school, every student shall submit a printed report (in triplicate)
on the practice school he/she attended (not more than 25 pages). Along with the exams of
semester VII, the report submitted by the student, knowledge and skills acquired by the
student through practice school shall be evaluated by the subject experts at college
leveland grade point shall be awarded.
SEMESTER VIII
BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

45 Hours

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability
theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA,
Introduction to Design of Experiments, Phases of Clinical trials and Observational and
Experimental studies, SPSS, R and MINITAB statistical software’s, analyzing the
statistical data using Excel.

Objectives: Upon completion of the course the student shall be able to


• Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of
Experiment)
• Know the various statistical techniques to solve statistical problems
• Appreciate statistical techniques in solving the problems.

Course content:
Unit-I 10 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical
problems
Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation -
Pharmaceuticals examples

Unit-II 10 Hours
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x
= a + by, Multiple regression, standard error of regression– Pharmaceutical Examples
Probability:Definition of probability, Binomial distribution, Normal distribution,
Poisson’s distribution, properties - problems
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis,
sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard
error of mean (SEM) - Pharmaceutical examples
Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way
and Two way), Least Significance difference

Unit-III 10 Hours
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis
test, Friedman Test
Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph
Designing the methodology: Sample size determination and Power of a study, Report
writing and presentation of data, Protocol, Cohorts studies, Observational studies,
Experimental studies, Designing clinical trial, various phases.

Unit-IV 8 Hours
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels
Introduction to Practical components of Industrial and Clinical Trials Problems:
Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R -
Online Statistical Software’s to Industrial and Clinical trial approach

Unit-V 7Hours
Design and Analysis of experiments:
Factorial Design: Definition, 22, 23design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design,
Optimization Techniques

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,


publisher Marcel Dekker Inc. NewYork.
2. S.C.Guptha. Fundamental of Statistics – Himalaya Publishing House.
3. R. Pannerselvam. Design and Analysis of Experiments –PHI Learning
Private Limited,
4. Douglas and C. Montgomery. Design and Analysis of Experiments – Wiley
Students Edition.
BP 802T SOCIAL AND PREVENTIVE PHARMACY

Hours: 45

Scope:
The purpose of this course is to introduce to students a number of health issues and their
challenges. This course also introduced a number of national health programmes. The
roles of the pharmacist in these contexts are also discussed.

Objectives:
After the successful completion of this course, the student shall be able to:
 Acquire high consciousness/realization of current issuesrelated to health and
pharmaceutical problems within the country and worldwide.
 Have a critical way of thinking based on current healthcare development.
 Evaluate alternative ways of solving problems related tohealth and
pharmaceutical issues
Course content:

Unit I: 10 Hours
Concept of health and disease: Definition, concepts and evaluation of public health.
Understanding the concept of prevention and control of disease, social causes of diseases
and social problems of the sick.

Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.

Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health

Hygiene and health: personal hygiene and health care; avoidable habits

Unit II: 10 Hours


Preventive medicine: General principles of prevention and control of diseases such as
cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken
guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse

Unit III: 10 Hours


National health programs, its objectives, functioning and outcome of the following:
HIV AND AIDS control programme, TB, Integrated disease surveillance program
(IDSP), National leprosy control programme, National mental health program, National
programme for prevention and control of deafness, Universal immunization programme,
National programme for control of blindness, Pulse polio programme.

Unit IV: 08 Hours


National health intervention programme for mother and child, National family welfare
programme, National tobacco control programme, National Malaria Prevention Program,
National programme for the health care for the elderly, Social health programme; role of
WHO in Indian national program

Unit V: 07 Hours
Community services in rural, urban and school health: Functions of PHC, Improvement
in rural sanitation, national urban health mission, Health promotion and education in
school.

Recommended Books (Latest edition):

1. G N Prabhakara. Short Textbook of Preventive and Social Medicine, 2 nd Edition,


2010, ISBN: 9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta), Edited by Ro y
Rabindra Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE
Publications
3. V i v e k Jain. Review of Preventive and Social Medicine (Including Biostatistics),
6 th Edition, 2014, ISBN: 9789351522331, JAYPEE Publications
4. L D Hiremath, D A Hiremath, Essentials of Community Medicine—A
nd
Practical Approach, 2 Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
5. K Park. Park Textbook of Preventive and Social Medicine, 21 st Edition, 2011,
ISBN-14: 9788190128285, BANARSIDAS BHANOT PUBLISHERS.
6. Ramesh Adepu. Community Pharmacy Practice, BSP publishers, Hyderabad.

Recommended Journals:

1. Research in Social and Administrative Pharmacy, Elsevier, Ireland


BP803ET. PHARMA MARKETING MANAGEMENT (Theory)

45 Hours
Scope:
The pharmaceutical industry not onl y needs highly qualified researchers, chemists and,
technical people, but also requires skilled managers who can take the industry forward
by managing and taking the complex decisions which are imperative for the growth of the
industry. The Knowledge and Know-how of marketing management groom the people
for taking a challenging role in Sales and Product management.

Course Objective: The course aims to provide an understanding of marketing concepts


and techniques and their applications in the pharmaceutical industry.

Unit I 10 Hours
Marketing:
Definition, general concepts and scope of marketing; Distinction between marketing &
selling; Marketing environment; Industry and competitive analysis; Analyzing consumer
buying behavior; industrial buying behavior.

Pharmaceutical market:
Quantitative and qualitative aspects; size and composition of the market; demographic
descriptions and socio-psychological characteristics of the consumer; market
segmentation& targeting.Consumer profile; Motivation and prescribing habits of the
physician; patients' choice of physician and retail pharmacist.Analyzing the Market;Role
of market research.

Unit II 10 Hours
Product decision:
Classification, product line and product mix decisions, product life
cycle,product portfolio analysis; product positioning; New product decisions; Product
branding, packaging and labeling decisions, Product management in pharmaceutical
industry.

Unit III 10 Hours


Promotion:
Methods, determinants of promotional mix, promotional budget; An overview of
personal selling, advertising, direct mail, journals, sampling, retailing, medical
exhibition, public relations, online promotional techniques for OTC Products.
Unit IV 10 Hours
Pharmaceutical marketing channels:
Designing channel, channel members, selecting the appropriate channel, conflict in
channels, physical distribution management: Strategic importance, tasks in physical
distribution management.

Professional sales representative (PSR):


Duties of PSR, purpose of detailing, selection and training, supervising, norms for
customer calls, motivating, evaluating, compensation and future prospects of the PSR.

Unit V 10 Hours
Pricing:
Meaning, importance, objectives, determinants of price; pricing methods and strategies,
issues in price management in pharmaceutical industry. An overview of DPCO
(Drug Price Control Order)and NPPA (National Pharmaceutical Pricing Authority).

Emerging concepts in marketing:


Vertical & Horizontal Marketing; RuralMarketing; Consumerism; Industrial Marketing;
Global Marketing.

Recommended Books: (Latest Editions)


1. Philip Kotler and Kevin Lane Keller: Marketing Management, Prentice Hall of India,
New Delhi
2. Walker, Boyd and Larreche : Marketing Strategy- Planning and Implementation, Tata
MC GrawHill, New Delhi.
3. Dhruv Grewal and Michael Levy: Marketing, Tata MC Graw Hill
4. Arun Kumar and N Menakshi: Marketing Management, Vikas Publishing, India
5. Rajan Saxena: Marketing Management; Tata MC Graw-Hill (India Edition)
6. Ramaswamy, U.S & Nanakamari, S: Marketing Managemnt:Global Perspective,
IndianContext,Macmilan India, New Delhi.
7. Shanker, Ravi: Service Marketing, Excell Books, New Delhi
8. Subba Rao Changanti, Pharmaceutical Marketing in India (GIFT – Excel series) Excel
Publications.
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)

45Hours

Scope: This course is designed to impart the fundamental knowledge on the regulator y
requirements for approval of new drugs, and drug products in regulated markets of
India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students
to learn in detail on the regulatory requirements, documentation requirements, and
registration procedures for marketing the drug products.

Objectives: Upon completion of the subject student shall be able to;


1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale
of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and
international markets
Course content:

Unit I 10Hours

New Drug Discovery and development


Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.

Unit II 10Hours

Regulatory Approval Process


Approval processes and timelines involved in Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an
approved NDA / ANDA.
Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)

Unit III 10Hours

Registration of Indian drug product in overseas market


Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical
Document (eCTD), ASEAN Common Technical Document (ACTD)research.

Unit IV 08Hours

Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and
procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and
Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials

Unit V 07Hours

Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

Recommended books (Latest edition):


1. Sachin Itkar, Dr. N.S. Vyawahare. Drug Regulatory Affairs, Nirali Prakashan.
2. Ira R. Berry and Robert P. Martin. The Pharmaceutical Regulatory Process, Second
Edition Edited, Drugs and the Pharmaceutical Sciences,Vol.185. Informa Health
care Publishers.
3. Richard A Guarino, New Drug Approval Process: Accelerating Global
Registrations MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley &
Sons. Inc.
5. Douglas J. Pisano, David Mantus FDA Regulatory Affairs: a guide for
prescription drugs, medical devices, and biologics /edited.
6. Leon Shargel and Isader Kaufer. Generic Drug Product Development, Solid Oral
Dosage forms, Marcel Dekker series, Vol.143
7. A Fay Rozovsky and Rodney K. Adams. Clinical Trials and Human Research: A
Practical Guide to Regulatory Compliance
8. John I. Gallin and Frederick P. Ognibene. Principles and Practices of Clinical
Research, Second Edition Edited.
9. N G Rick. Drugs: From Discovery to Approval, Second Edition.
BP 805T: PHARMACOVIGILANCE (Theory)
45 hours

Scope: This paper will provide an opportunity for the student to learn about development of
pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario
of Pharmacovigilance, train students on establishing pharmacovigilance programme in an
organization, various methods that can be used to generate safety data and signal detection. This
paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

Objectives:
At completion of this paper it is expected that students will be able to (know, do, and
appreciate):
1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during pre clinical, clinical and post approval phases of
drugs’ life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.

Course Content

Unit I 10 Hours
Introduction to Pharmacovigilance
 History and development of Pharmacovigilance
 Importance of safety monitoring of Medicine
 WHO international drug monitoring programme
 Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
 Definitions and classification of ADRs
 Detection and reporting
 Methods in Causality assessment
 Severity and seriousness assessment
 Predictability and preventability assessment
 Management of adverse drug reactions
Basic terminologies used in pharmacovigilance

 Terminologies of adverse medication related events


 Regulatory terminologies
Unit II 10 hours
Drug and disease classification
 Anatomical, therapeutic and chemical classification of drugs
 International classification of diseases
 Daily defined doses
 International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
 WHO adverse reaction terminologies
 MedDRA and Standardised MedDRA queries
 WHO drug dictionary
 Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
 Basic drug information resources
 Specialised resources for ADRs
Establishing pharmacovigilance programme
 Establishing in a hospital
 Establishment & operation of drug safety department in industry
 Contract Research Organisations (CROs)
 Establishing a national programme

Unit III 10 Hours


Vaccine safety surveillance
 Vaccine Pharmacovigilance
 Vaccination failure
 Adverse events following immunization
Pharmacovigilance methods
 Passive surveillance – Spontaneous reports and case series
 Stimulated reporting
 Active surveillance – Sentinel sites, drug event monitoring and registries
 Comparative observational studies – Cross sectional study, case control study and
cohort study
 Targeted clinical investigations
Communication in pharmacovigilance
 Effective communication in Pharmacovigilance
 Communication in Drug Safety Crisis management
 Communicating with Regulatory Agencies, Business Partners, Healthcare facilities &
Media
Unit IV 8 Hours
Safety data generation
 Pre clinical phase
 Clinical phase
 Post approval phase (PMS)
ICH Guidelines for Pharmacovigilance
 Organization and objectives of ICH
 Expedited reporting
 Individual case safety reports
 Periodic safety update reports
 Post approval expedited reporting
 Pharmacovigilance planning
 Good clinical practice in pharmacovigilance studies
Unit V 7 hours
Pharmacogenomics of adverse drug reactions
 Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
 Paediatrics
 Pregnancy and lactation
 Geriatrics
CIOMS
 CIOMS Working Groups
 CIOMS Form
CDSCO (India) and Pharmacovigilance
 D&C Act and Schedule Y
 Differences in Indian and global pharmacovigilance requirements
Recommended Books (Latest edition):
1. S K Gupta, Textbook of Pharmacovigilance: Jaypee Brothers, Medical Publishers.
2. Barton Cobert & Pierre Biron. Practical Drug Safety from A to Z, Jones and
Bartlett Publishers.
3. Elizabeth B. Andrews, Nicholas. Mann's Pharmacovigilance:, Wiley Publishers.
4. John Talbot, Patrick Walle, Stephens' Detection of New Adverse Drug Reactions:
Wiley Publishers.
5. Patrick Waller. An Introduction to Pharmacovigilance,,Wiley Publishers.
6. Barton Cobert. Cobert's Manual of Drug Safety and Pharmacovigilance: Bartlett
& Jones Publishers.
7. Brian L Strom, Stephen E Kimmel, Sean Hennessy. Textbook of Pharmacoepidemiolog
edited Wiley Publishers.
8. G. Parthasarathi, Karin Nyfort, Hansen,Milap, C. Nahata. A Textbook of Clinical
Pharmacy Practice -Essential Concepts and Skills.
9. National Formulary of India
10. Yashpal Munjal. Text Book of Medicine.
11. GP Mohanta and PK Manna. Text book of Pharmacovigilance: concept and
practice.
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn
3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html
BP 806 ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS
(Theory)

Scope: In this subject the student learns about the various methods and guidelines for
evaluation and standardization of herbs and herbal drugs. The subject also provides an
opportunity for the student to learn cGMP, GAP and GLP in traditional system of
medicines.

Objectives: Upon completion of the subject student shall be able to;


1. know WHO guidelines for quality control of herbal drugs
2. know Quality assurance in herbal drug industry
3. know the regulatory approval process and their registration in Indian and
international markets
4. appreciate EU and ICH guidelines for quality control of herbal drugs

Unit I 10 hours
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage
forms
WHO guidelines for quality control of herbal drugs.
Evaluation of commercial crude drugs intended for use

Unit II 10 hours
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in
traditional system of medicine.

WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.

Unit III 10 hours


EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Unit IV 08 hours
Stability testing of herbal medicines.Application of various chromatographic techniques
in standardization of herbal products.
Preparation of documents for new drug application and export registration
GMP requirements and Drugs & Cosmetics Act provisions.
Unit V 07 hours
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products

Recommended Books: (Latest Editions


1. Trease and Evans. Pharmacognosy.
2. Kokate, Purohit and Gokhale. Pharmacognosy.
3. V D Rangari. Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
Pub., 2006.
4. S S Aggrawal, Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
Products,
6. P Mukherjee, Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
7. M V Shinde, K Dhalwal, K Potdar, K Mahadik. Application of quality control
principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health
Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal
Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
World Health Organization, Geneva, 1981.
10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva, 1999.
11. WHO. WHO Global Atlas of Traditional, Complementary and Alternative
Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health
Organization, Geneva, 2005.
12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants. World Health Organization, Geneva, 2004.
BP 807 ET. COMPUTER AIDED DRUG DESIGN (Theory)

45 Hours
Scope: This subject is designed to provide detailed knowledge of rational drug design
process and various techniques used in rational drug design process.
Objectives: Upon completion of the course, the student shall be able to understand
 Design and discovery of lead molecules
 The role of drug design in drug discovery process
 The concept of QSAR and docking
 Various strategies to develop new drug like molecules.
 The design of new drug molecules using molecular modeling software

Course Content:
UNIT-I 10 Hours
Introduction to Drug Discovery and Development
Stages of drug discovery and development
Lead discovery and Analog Based Drug Design
Rational approaches to lead discovery based on traditional medicine,
Random screening, Non-random screening, serendipitous drug discovery,
lead discovery based on drug metabolism, lead discovery based on
clinical observation.
Analog Based Drug Design:Bioisosterism, Classification, Bioisosteric
replacement. Any three case studies

UNIT-II 10 Hours
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of
physicochemical parameters, experimental and theoretical approaches for
the determination of physicochemical parameters such as Partition
coefficient, Hammet’s substituent constant and Tafts steric constant.
Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.

UNIT-III 10 Hours
Molecular Modeling and virtual screening techniques
Virtual Screening techniques: Drug likeness screening, Concept of
pharmacophore mapping and pharmacophore based Screening,
Molecular docking: Rigid docking, flexible docking, manual docking,
Docking based screening. De novo drug design.
UNIT-IV 08 Hours
Informatics & Methods in drug design
Introduction to Bioinformatics, chemoinformatics. ADME databases,
chemical, biochemical and pharmaceutical databases.

UNIT-V 07 Hours
Molecular Modeling: Introduction to molecular mechanics and quantum
mechanics.Energy Minimization methods and Conformational Analysis,
global conformational minima determination.

Recommended Books (Latest Editions)

1. G C K Robert, Drug Action at the Molecular Level, University Prak Press Baltimore.
2. Y C Martin. Quantitative Drug Design” Dekker, New York.
3. J N Delgado, W A Remers, Wilson & Gisvolds’s Text Book of Organic
Medicinal & Pharmaceutical Chemistry Lippincott, New York.
4. W O Foye, Principles of Medicinal chemistry ‘Lea & Febiger.
5. A Koro lkovas, J H Burckhalter. Essentials of Medicinal Chemistry, Wiley
Interscience.
6. M E Wolf. The Basis of Medicinal Chemistry, Burger’s Medicinal Chemistry,
John Wiley & Sons, New York.
7. Patrick Graham, An Introduction to Medicinal Chemistry, Oxford University
Press.
8. H J Smith, H Williams, Introduction to the principles of Drug Design,
Wright Boston.
9. R B Silverman. The organic Chemistry of Drug Design and Drug Action,
Academic Press New York.
BP808ET: CELL AND MOLECULAR BIOLOGY (Elective subject)
45 Hours

Scope:
 Cell biology is a branch of biology that studies cells – their physiological
properties, their structure, the organelles they contain, interactions with their
environment, their life cycle, division, death and cell function.
 This is done both on a microscopic and molecular level.
 Cell biology research encompasses both the great diversity of single-celled
organisms like bacteria and protozoa, as well as the many specialized cells in
multi-cellular organismssuch as humans, plants, and sponges.

Objectives: Upon completion of the subject student shall be able to;


 Summarize cell and molecular biology history.
 Summarize cellular functioning and composition.
 Describe the chemical foundations of cell biology.
 Summarize the DNA properties of cell biology.
 Describe protein structure and function.
 Describe cellular membrane structure and function.
 Describe basic molecular genetic mechanisms.
 Summarize the Cell Cycle
Course content:
Unit I 10Hours
a) Cell and Molecular Biology: Definitions theory and basics and Applications.
b) Cell and Molecular Biology: History and Summation.
c) Properties of cells and cell membrane.
d) Prokaryotic versus Eukaryotic
e) Cellular Reproduction
f) Chemical Foundations – an Introduction and Reactions (Types)

Unit II 10 Hours
a) DNA and the Flow of Molecular Information
b) DNA Functioning
c) DNA and RNA
d) Types of RNA
e) Transcription and Translation

Unit III 10 Hours


a) Proteins: Defined and Amino Acids
b) Protein Structure
c) Regularities in Protein Pathways
d) Cellular Processes
e) Positive Control and significance of Protein Synthesis
Unit IV 08 Hours
a) Science of Genetics
b) Transgenics and Genomic Analysis
c) Cell Cycle analysis
d) Mitosis and Meiosis
e) Cellular Activities and Checkpoints

Unit V 07 Hours
a) Cell Signals: Introduction
b) Receptors for Cell Signals
c) Signaling Pathways: Overview
d) Misregulation of Signaling Pathways
e) Protein-Kinases: Functioning

Recommended Books (latest edition):


1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers &
Distributors, Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. Edward: Fundamentals of Microbiology.
10. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
11. Bergeys manual of systematic bacteriology, Williams and Wilkins- A Waverly
company
12. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and
Applications of RecombinantDNA: ASM Press Washington D.C.
13. RA Goldshy et. al., : Kuby Immunology.
BP809ET. COSMETIC SCIENCE(Theory)
45Hours

UNIT I 10Hours
Classification of cosmetic and cosmeceutical products
Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals
from cosmetics, cosmetics as quasi and OTC drugs
Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients,
preservatives. Classification and application
Skin: Basic structure and function of skin.
Hair: Basic structure of hair. Hair growth cycle.
Oral Cavity: Common problem associated with teeth and gums.

UNIT II 10 Hours
Principles of formulation and building blocks of skin care products:
Face wash,
Moisturizing cream, Cold Cream, Vanishing cream and their advantages and
disadvantages.Application of these products in formulation of cosmecuticals.
Antiperspants & deodorants- Actives & mechanism of action.
Principles of formulation and building blocks of Hair care products:
Conditioning shampoo, Hair conditioner,anti-dandruff shampoo.
Hair oils.
Chemistry and formulation of Para-phylene diamine based hair dye.
Principles of formulation and building blocks of oral care products:
Toothpaste for bleeding gums, sensitive teeth. Teeth whitening, Mouthwash.

UNIT III 10 Hours


Sun protection, Classification of Sunscreens and SPF.
Role of herbs in cosmetics:
Skin Care: Aloe and turmeric
Hair care: Henna and amla.
Oral care: Neem and clove
Analytical cosmetics: BIS specification and analytical methods for shampoo, skin-
cream and toothpaste.

UNIT IV 08 Hours.
Principles of Cosmetic Evaluation:Principles of sebumeter, corneometer. Measurement
of TEWL, Skin Color, Hair tensile strength, Hair combing properties
Soaps,and syndet bars. Evolution and skin benfits.
UNIT V 07 Hours
Oily and dry skin, causes leading to dry skin, skin moisturisation. Basic understanding of
the terms Comedogenic, dermatitis.
Cosmetic problems associated with Hair and scalp: Dandruff, Hair fall causes
Cosmetic problems associated with skin: blemishes, wrinkles, acne, prickly heat and
body odor.
Antiperspirants and Deodorants- Actives and mechanism of action

References
1) Wilkinson, Moore. Harry’s Cosmeticology, , Seventh Edition, George Godwin.
2) P.P. Sharma. Cosmetics – Formulations, Manufacturing and Quality Control, 4th
Edition, Vandana Publications Pvt. Ltd., Delhi.
3) Sanju Nanda & Roop K. Khar. Text book of cosmelicology, Tata Publishers.
BP810 ET. EXPERIMENTAL PHARMACOLOGY
(PHARMACOLOGICAL SCREENING METHODS)

45 Hours

Scope:This subject is designed to impart the basic knowledge of preclinical studies in


experimental animals including design, conduct and interpretations of results.

Objectives
Upon completion of the course the student shall be able to,
 Appreciate the applications of various commonly used laboratory animals.
 Appreciate and demonstrate the various screening methods used in preclinical
research
 Appreciate and demonstrate the importance of biostatistics and researchmethodology
 Design and execute a research hypothesis independently

Unit –I 08 Hours
Laboratory Animals:
Study of CPCSEA and OECD guidelines for maintenance, breeding
and conduct of experiments on laboratory animals, Common lab
animals: Description and applications of different species and strains
of animals. Popular transgenic and mutant animals.
Techniques for collection of blood and common routes of drug
administration in laboratory animals, Techniques of blood collection
and euthanasia.
Unit –II 10 Hours
Preclinical screening models
a. Introduction: Dose selection, calculation and conversions,
preparation of drug solution/suspensions, grouping of animals and
importance of sham negative and positive control groups.
Rationale for selection of animal species and sex for the study.
b. Study of screening animal models for
Diuretics, nootropics, anti-Parkinson’s,antiasthmatics,
Preclinical screening models: for CNS activity- analgesic,
antipyretic,anti-inflammatory, general anaesthetics, sedative and
hypnotics, antipsychotic, antidepressant, antiepileptic,
antiparkinsonism, alzheimer’s disease
Unit –III

Preclinical screening models: for ANS activity, sympathomimetics,


sympathol ytics, parasympathomimetics, parasympatholytics, skeletal
muscle relaxants, drugs acting on eye, local anaethetics

Unit –IV

Preclinical screening models: for CVS activity- antihypertensives,


diuretics, antiarrhythmic, antidyslepidemic, anti aggregatory,
coagulants, and anticoagulants
Preclinical screening models for other important drugs like antiulcer,
antidiabetic, anticancer and antiasthmatics.

Research methodology and Bio-statistics 05 Hours


Selection of research topic, review of literature, research hypothesis
and study design
Pre-clinical data analysis and interpretation using Students ‘t’ test
and One-way ANOVA. Graphical representation of data
Recommended Books (latest edition):

1. M.N.Ghosh. Fundamentals of experimental Pharmacology.


2. S.K.Kulakarni. Hand book of Experimental Pharmacology.
3. CPCSEA guidelines for laboratory animal facility.
4. H G Vogel. Drug discovery and Evaluation.
5. Suresh Kumar Gupta and S. K. Gupta. Drug Screening Methods.
6. PSS Sundar Rao and J Richard. Introduction to biostatistics and research
methods.
7. Robert A Tumer. Screening methods in Pharmacology.
8. Laurence & Bachrach. Evaluation of drug activities.
9. R.K. Goyal. Experimental Pharmacology.
10. T K Chatterjee. Rodents for Pharmacological Experiments.
BP 811 ET. ADVANCED INSTRUMENTATION TECHNIQUES
45 Hours

Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart advanced knowledge on
the principles and instrumentation of spectroscopic and chromatographic hyphenated
techniques. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.

Objectives:Upon completion of the course the student shall be able to


 understand the advanced instruments used and its applications in drug analysis
 understand the chromatographic separation and analysis of drugs.
 understand the calibration of various analytical instruments
 know analysis of drugs using various analytical instruments.

Course Content:
UNIT-I 10 Hours
Nuclear Magnetic Resonance spectroscopy
Principles of H-NMR and C-NMR, chemical shift, factors affecting chemical
shift, coupling constant, Spin - spin coupling, relaxation, instrumentation and
applications
Mass Spectrometry- Principles, Fragmentation, Ionization techniques –
Electron impact, chemical ionization, MALDI, FAB, Anal yzers-Time of
flight and Quadrupole, instrumentation, applications

UNIT-II 10 Hours
Thermal Methods of Analysis: Principles, instrumentation and applications
of ThermogravimetricAnalysis (TGA), Differential Thermal Analysis (DTA),
Differential Scanning Calorimetry (DSC)
X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X- ray
Crystallography, rotating crystal technique, single crystal diffraction,powder
diffraction, structural elucidation and applications.

UNIT-III 10 Hours
Calibration and validation-as per ICH and USFDA guidelines
Calibration of following Instruments
Electronic balance, UV-Visible spectrophotometer, IR spectrophotometer, F luorimeter,
Flame Photometer, HPLC and GC
UNIT-IV 08 Hours
Radio immune assay:Importance, various components, Principle, different
methods, Limitation and Applications of Radio immuno assay
Extraction techniques:General principle and procedure involved in the solid
phase extraction and liquid-liquid extraction

UNIT-V 07 Hours
Hyphenated techniques-LC-MS/MS, GC-MS/MS, HPTLC-MS.

Recommended Books (Latest Editions)


1. B.K Sharma. Instrumental Methods of Chemical Analysis.
2. Y.R Sharma. Organic spectroscopy.
3. Kenneth A Connors. Text book of Pharmaceutical Analysis.
4. A.I. Vogel. Vogel’s Text book of Quantitative Chemical Analysis.
5. A.H. Beckett and J.B. Stenlake. Practical Pharmaceutical Chemistry
6. I. L. Finar. Organic Chemistry.
7. William Kemp. Organic spectroscopy
8. D. C. Garrett. Quantitative Analysis of Drugs
9. P. D. Sethi. Quantitative Analysis of Drugs in Pharmaceutical Formulations.
10. Silverstein. Spectrophotometric identification of Organic Compounds.
BP 812 ET. DIETARY SUPPLEMENTS AND NUTRACEUTICALS

No. of hours :3 Tutorial:1 Credit point:4

Scope :

This subject covers foundational topic that are important for understanding the need and
requirements of dietary supplements among different groups in the population.

Objective:

This module aims to provide an understanding of the concepts behind the theoretical
applications of dietary supplements. By the end of the course, students should be able to :

1. Understand the need of supplements by the different group of people to maintain


healthy life.
2. Understand the outcome of deficiencies in dietary supplements.
3. Appreciate the components in dietary supplements and the application.
4. Appreciate the regulatory and commercial aspects of dietary supplements including
health claims.
UNIT I 07 hours

a. Definitions of Functional foods, Nutraceuticals and Dietary supplements. Classification


of Nutraceuticals, Health problems and diseases that can be prevented or cured by
Nutraceuticals i.e. weight control, diabetes, cancer, heart disease, stress, osteoarthritis,
hypertension etc.
b. Public health nutrition, maternal and child nutrition, nutrition and ageing, nutrition
education in community.
c. Source, Name of marker compounds and their chemical nature, Medicinal uses and
health benefits of following used as nutraceuticals/functional foods: Spirulina,
Soyabean, Ginseng, Garlic, Broccoli, Gingko, Flaxseeds
UNIT II 15 hours

Phytochemicals as nutraceuticals: Occurrence and characteristic features(chemical nature


medicinal benefits) of following

a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin


b) Sulfides: Diallyl sulfides, Allyl trisulfide.
c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins, Flavones
e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum
f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans
g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as functional foods: oats,
wheat bran, rice bran, sea foods, coffee, tea and the like.
UNIT III 07 hours
a) Introduction to free radicals: Free radicals, reactive oxygen species, production of free
radicals in cells, damaging reactions of free radicals on lipids, proteins,
Carbohydrates, nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food ingredients..
UNIT IV 10 hours

a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion injury, Cancer,


Atherosclerosis, Free radicals in brain metabolism and pathology, kidney damage,
muscle damage. Free radicals involvement in other disorders. Free radicals theory of
ageing.
b) Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic antioxidant
defence, Superoxide dismutase, catalase, Glutathione peroxidase, Glutathione
Vitamin C, Vitamin E, α- Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy Anisole.
c) Functional foods for chronic disease prevention

UNIT V 06 hours

a) Effect of processing, storage and interactions of various environmental factors on the


potential of nutraceuticals.

b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food
Safety. Adulteration of foods.

c) Pharmacopoeial Specifications for dietary supplements and nutraceuticals.

References:

1. Dietetics by Sri Lakshmi


2. K.T Agusti and P.FaizaRole of dietary fibres and neutraceuticals in preventing
diseasesl: BSPunblication.
3. K A Cooper. Advanced Nutritional Therapies., (1996).
4. Jean Carper, Simon & Schuster. The Food Pharmacy, UK Ltd., (1988).
5. James F.Balch and Phyllis A.Balch. Prescription for Nutritional Healing 2 nd Edn.,
Avery Publishing Group, NY (1997).
6. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
7. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
8. T P Labuza, 2000 Functional Foods and Dietary Supplements: Safety, Good
Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional
Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
9. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
10. M E Shils, J A Olson, M Shike, Modern Nutrition in Health and Disease. Eighth
edition. Lea and Febiger
BP 813 ET : Elective course on Pharmaceutical Product Development
No of Hours: 3 Tutorial:1 Credit points:4
Unit-I 10 Hours
Introduction to pharmaceutical product development, objectives, regulations related to
preformulation, formulation development, stability assessment, manufacturing and
quality control testing of different types of dosage forms

Unit-II 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i. Solvents and solubilizers
ii. Cyclodextrins and their applications
iii. Non - ionic surfactants and their applications
iv. Polyethylene glycols and sorbitols
v. Suspending and emulsifying agents
vi. Semi solid excipients

Unit-III 10 Hours
An advanced study of Pharmaceutical Excipients in pharmaceutical product development
with a special reference to the following categories
i. Tablet and capsule excipients
ii. Directly compressible vehicles
iii. Coat materials
iv. Excipients in parenteral and aerosols products
v. Excipients for formulation of NDDS
Selection and application of excipients in pharmaceutical formulations with specific
industrial applications

Unit-IV 08 Hours
Optimization techniques in pharmaceutical product development.A study of various
optimization techniques for pharmaceutical product development with specific
examples.Optimization by factorial designs and their applications.A study of QbD and its
application in pharmaceutical product development.

Unit-V 07 Hours
Selection and quality control testing of packaging materials for pharmaceutical product
development- regulatory considerations.
Recommended Books (Latest editions)
1. Stanford Bolton, CharlesBon. Pharmaceutical Statistics Practical and Clinical
Applications; Marcel Dekker Inc.
2. James swarbrick. Encyclopedia of Pharmaceutical Technology, edited, Third
Edition,Informa Healthcare publishers.
3. Herbert A. Lieberman andLeon Lachman Pharmaceutical Dosage Forms, Tablets,
Volume II, edited; Marcel Dekker, Inc.
4. Roop kKhar, S P Vyas, Farhan J Ahmad, Gaurav K Jain. The Theory and Practice of
Industrial Pharmacy, Fourth Edition, edited; CBS Publishers and Distributors
Pvt.Ltd. 2013.
5. Patrick J. Sinko. Martin’s Physical Pharmacy and Pharmaceutical Sciences, Fifth
Edition, edited by , BI Publications Pvt. Ltd.
6. S. P. Vyas and R. K.Khar. Targeted and Controlled Drug Delivery, Novel Carrier
Systems , CBS Publishers and Distributors Pvt. Ltd, First Edition 2012.
7. Loyd V. Allen Jr., Nicholas B.Popovich, Howard C. Ansel, Pharmaceutical
Dosage Forms and Drug Delivery Systems, 9th Ed. 40
8. Michael E Aulton. Aulton’s Pharmaceutics – The Design and Manufacture of
Medicines ,3rd Ed.
9. Remington – The Science and Practice of Pharmacy, 20th Ed.
10. A. Liberman, Leon Lachman and Joseph B. Schwartz. Pharmaceutical Dosage
Forms – Tablets Vol 1 to 3.
11. H.A. Liberman, Martin, M.R and Gilbert S. Banker. Pharmaceutical Dosage
Forms – Disperse Systems Vol 1 to 3.
12. Kenneth E. Avis and H.A. Libermann. Pharmaceutical Dosage Forms – Parenteral
Medication Vol 1 & 2.
13. Advanced Review Articles related to the topics.
BP 814 PW : Project work

All the students shall undertake a projectunder the supervision of a teacher and submit a
report. The area of the project shall directly relate any one of the elective subject opted by
the student in semester VIII. The project shall be carried out in group not exceeding 5 in
number. The project report shall be submitted in triplicate (typed & bound copy not less
than 25 pages).
The internal and external examiner appointed by the University shall evaluate the project
at the time of the Practical examinations of other semester(s). Students shall be evaluated
in groups for four hours (i.e., about half an hour for a group of five students). The
projects shall be evaluated as per the criteria given below.

Evaluation of Dissertation Book:


Objective(s) of the work done 15 Marks
Methodology adopted 20 Marks
Results and Discussions 20 Marks
Conclusions and Outcomes 20 Marks
Total 75 Marks

Evaluation of Presentation:
Presentation of work 25 Marks
Communication skills 20 Marks
Question and answer skills 30 Marks
Total 75 Marks

Explanation: The 75 marks assigned to the dissertation book shall be same for all the
students in a group. However, the 75 marks assigned for presentation shall be awarded
based on the performance of individual students in the given criteria.

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