Sikkim University: Rules & Syllabus For The Bachelor of Pharmacy (B. Pharm) Course
Sikkim University: Rules & Syllabus For The Bachelor of Pharmacy (B. Pharm) Course
B. Pharm
(1st – 8th Semester)
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.
* 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
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.
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.
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.
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 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.
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.
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.
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
Scope: To learn and understand the components of living world, structure and functional
system of plant and animal kingdom.
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.
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.
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,
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
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
Unit III
Respiratory system 10 hours
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
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.
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
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.
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 V 7 Hours
Infectious diseases:Meningitis,Typhoid, Leprosy, Tuberculosis, Urinary tract infections
Sexually transmitted diseases:AIDS, Syphilis, Gonorrhea
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
UNIT-V 06 hours
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.
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
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
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
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.
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-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
4 Hours/week
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.
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
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
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
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
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
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
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.
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
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:
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
UNIT- IV 08 Hours
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.*
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.
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)
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.
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
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos
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:
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
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)
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.
II Assay of drugs
1 Isonicotinic acid hydrazide
2 Chloroquine
3 Metronidazole
4 Dapsone
5 Chlorpheniramine maleate
6 Benzyl penicillin
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
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
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
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.
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
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.
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.
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.
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
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.
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
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
UNIT –V 07 Hours
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.
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.
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.
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.
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.
d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.
c) Patient
counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist
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.
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
Journals:
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
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.
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
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 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 Journals:
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.
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 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).
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.
Unit I 10Hours
Unit II 10Hours
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
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
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.
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 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
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.
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.
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 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
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 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
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
Unit –IV
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.
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.
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 :
UNIT V 06 hours
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and GMPs on Food
Safety. Adulteration of foods.
References:
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 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.