Ayurveda: Does It Really Work?

Solid Dosage
Medically Forms by Jabeen
Reviewed
Begum, MD on November 23, 2023
Written
Tabletsby Tammy Worth
Ayurveda (a Sanskrit word that
means "science of life" or "knowledge
Tablets are solid pharmaceutical dosage
of life") is one offorms containing
the world's drug substances with or
oldest
whole-body healing systems. It was
developed more than 5,000 years ago
without suitable diluents and prepared by different methods .
in India.
Ayurveda is based on the belief that
health and wellness depend on a
Types
delicate of tablets
balance between the mind,
body, spirit, and environment. The
main goal
1) Conventional compressed of ayurvedic medicine is to
tablets:
promote good health and prevent, not
fight, disease. But treatments may be
To provide rapid disintegration geared
and toward specific
hence rapid drughealth
release.
.problems

Prepared by compression of granules or powders into the required geometry.

 2) Multiple compressed tablets:

I. Multiple-layered II. Compression coated

owder mix/granules containing drug Powder mix/granules containing drug

Light compression Light compression

Compression of the
powder/granule mix on Second tablet press Granules/powders
top of the second coat
Reasons for multiple compressed tablets:

1) To avoid incompatibilities,

2) To deliver drugs at different rates or to different sites within the gastrointestinal tract.

Reasons for compression coated tablets:

3) To mask a bitter taste of the drug,

4) To protect the stomach or

5) To avoid drug degradation (chemically unstable) under acidic conditions.

3) Enteric-coated tablets:

Coated with enteric polymer

The tablet will disintegrate and the drug will dissolve in the intestinal fluids.

Enteric polymers:

 Inhibit the dissolution of drug within the stomach.

 Protection against possible drug degradation.

Examples of enteric polymers:

I. Cellulose actetate phthalate.

II. Cellulose acetate butyrate.

III. Hydroxypropylmethyl cellulose succinate.

4) Sugar-coated tablets:
Conventional tablets that have been coated with a concentrated sugar solution to improve the
appearance of the formulation and/or to mask the bitter taste of the drug.

5) Film-coated tablets:
Conventional tablets that have been coated with a polymer or a mixture of polymers.
Generally less elegant than sugar coatings.
Film coatings polymers:
1) To improve mechanical properties,
2) To control the rate and duration of drug release or
3) To target drug release to certain regions of GIT, e.g. the colon.
Examples:
1. Hydroxypropylmethylcelluose,
2. Hydroxypropylcellulose and
3. Eudragit E100.
6) Chewable tablets:

Chewed within the buccal cavity prior to swallowing.

Reasons for chewable tablets:

 For people with difficulty in swallowing .

 For large tablet size (antacid formulations).

7) Effervescent tablets:

An organic acid + sodium bicarbonate + H2O Advantage

↑ absorption of poorly soluble drugs.
CO2
Disadvantages
The possible (un)availability of water.
Tablet disintegration (the patient then consumes Moisture-impermeable packaging
(typically aluminium foil),
8) Buccal and sublingual tablets
Held within the oral cavity and slowly dissolve; the drug is absorbed across the buccal mucosa
to produce a systemic effect.
Reasons for buccal and sublingual tablets:
1) Rapid absorption into the systemic circulation (e.g. nitroglycerine sublingual tablets)
2) Systemic drug absorption in situations where oral drug delivery is inappropriate, e.g.
nausea.
1) Bypass first-pass metabolism.
9) Vaginal tablets:
Ovoid-shaped tablets that are inserted into the vagina (using a special inserter).
The main applications for this dosage form are:
 Local effect (e.g. For the treatment of bacterial or fungal infection).
9) Lozenges

 Lozenges are slow dissolving compressed tablets that do not contain a disintegrant.

 Some lozenges contain antiseptics (e.g., benzalkonium) or antibiotics for local effects in the

mouth. Lozenges are also used for systemic effect, such as those containing vitamin

supplements. Lozenges are palatable and organoleptically appealing by the addition of flavors,

sweeteners, and colors.

 Advantages of tablets as dosage forms:
1) Convenient to use and an elegant dosage form.
2) Different types are available, offering rapid drug release or controlled drug release, the
latter reducing the number of daily doses required.
3) Releasing the drug at a particular site within the GIT to reduce side effects, promote
absorption at that site and provide a local effect.
4) Containing more than one drug.
5) All classes of drugs (except proteins) may be administered orally in the form of tablets.
6) Easily masking the taste of bitter drugs using tablets.
7) Easily manufactured to show product identification, e.g. exhibiting the required markings on
the surface.
8) The chemical, physical and microbiological stability of tablet dosage forms is superior to
other dosage forms.
 Disadvantages of tablets as dosage forms:

1) The manufacture of tablets requires a series of unit operations and therefore there is an

increased level of product loss at each stage in the manufacturing process.

2) The absorption of the drug from tablets is dependent on physiological factors, e.g. gastric

emptying rate, and shows interpatient variation.

3) Certain drugs are poorly compressible.

4) Difficulties in swallowing tablets to certain people, e.g. children and the elderly.
 Excipients used in the manufacture of tablets:

Diluents/fillers

 ↑ the mass of the tablets (potent drugs) to render the manufacturing process more reliable and

reproducible.

 Must exhibit good compression properties and be inexpensive.

Examples :
1. Anhydrous lactose;
2. Lactose monohydrate;
3. Spray-dried lactose;
4. Starch;
5. Dibasic calcium phosphate;
6. Microcrystalline cellulose (MCC); and
7. Mannitol.
Binders
Binders are predominantly polymeric substance that are employed in the production of tablets
by the wet granulation method.
Both solution binders and dry binders are included in the formulation at relatively low
concentrations, typically 2–10% by weight.
Examples:
1) Hydroxypropylmethylcellulose,
2) Polyvinylpyrrollidone,
3) Hydroxypropylcellulose,
4) Microcrystalline cellulose,
5) Sucrose and
6) Acacia.
Disintegrants
To facilitate the breakdown of the tablet into granules.

Porosity and wettability of the ↑ Water uptake Liberation of gas (carbon

compressed tablet (swelling) dioxide) whenever the tablet

contacts aqueous fluids
Penetration of GIF (effervescent tablets)
↑ Internal pressure

Tablet breakdown Tablet disintegration

Examples: Examples:
1. Sodium starch glycolate 1. Croscarmellose sodium,
2. Starch 2. Crospovidone.
3. Microcrystalline cellulose
Lubricants

During compression lubricants → ↓ friction at the interface between the face of the die and the

surface of the tablet,

During ejection of the tablet from the tablet press.

Inadequate lubrication → tablets with a pitted surface.

There are two main categories of lubricant:

1) Insoluble lubricants:
 Added to the final mixing stage prior to tablet compression.
 ↑ Concentrations → ↓rate of disintegration and dissolution.
 Insufficient concentration → tableting defects.
 Over mixing may adversely affect tablet disintegration and drug dissolution.
 Examples: (1) magnesium stearate, (2) stearic acid and (3) glyceryl behenate.
2) Soluble lubricants
• Employed to overcome the possible deleterious effects of their insoluble counterparts on the
time required for tablet disintegration and hence drug dissolution.
• The efficacy of insoluble lubricants is superior to soluble lubricants.
• Examples: (1) polyethylene glycol and (2) polyoxyethylene stearates

Glidants
• ↑ flow properties of the powders within the hopper and into
the tablet die in the tablet press.
• The glidant particles should be firstly small and, secondly, to
be arranged at the surface of the particles/granules.
• Typically hydrophobic and may adversely affect tablet
disintegration and drug dissolution. Examples: (1) talc; and
(2) colloidal silicon dioxide.
 Miscellaneous excipients used in the formulation of tablets:
Adsorbents:
 Whenever it is required to include a liquid or semisolid component, e.g. a drug or a flavour,
within the tablet formulation.
Examples:
1. Magnesium oxide/carbonate; and
2. Kaolin/bentonite.
Sweetening agents/flavours:
If the conventional tablet contains a bitter drug or if the tablet is a chewable tablet.
Examples:
1. Glucose; and
2. Aspartame.
Colours:
To improve the appearance or to identify the finished product uniquely.
Surface-active agents

• To improve the wetting properties of hydrophobic tablets and hence increase the rate of tablet

disintegration.

• To ↑ the aqueous solubility of poorly soluble drugs in the gastrointestinal tract and, as a result,

the rate of dissolution of the drug will increase.

• One of the most popular choices of surface-active agent for this purpose is sodium lauryl

sulphate.
 Manufacture of tablets:
1. Wet granulation,
2. Dry granulation (slugging),
3. Direct compression.
A series of steps:
 Mixing of drugs with the excipients.
 Granulation of the mixed powders.
 Mixing of the powders or granules with other excipients (most notably lubricants).
 Compression into tablets.
A number of factors for choosing preparation method:
• The physical and chemical stability of the drug during the manufacturing process.
• The availability of the necessary processing equipment.
• The cost of the manufacturing process.
• The excipients used to formulate the product.
 1. Wet granulation:

Stage 1: mixing of the drug with the powdered excipients (excluding the lubricant)

 Introduction of the powdered excipients and drug (excluding the lubricant) into a powder

mixer.

 The mixing speed and time must be sufficient in which the concentration of each component

in each region of the mixer is identical.

 Examples of mixers:

• Planetary bowl mixer

• Rotating drum mixers

• High-speed mixers

• Ribbon/trough mixers
Stage 2: wet granulation of the powder mix
Mixed powders are aggregated into and retained as larger particles (circa 0.2–4.0 mm in
diameter). Formation of granules facilitated by a binding agent, either in the solid state within
the powder mix or dissolved in the fluid. Spray granulating fluid (containing binder) on to the
powder mass whilst maintaining mixing.

Advantages for the use of granules in tablet manufacture:

1) Prevention of segregation of powder components.

Following mixing → segregation due to differences in the particle size and density → intrabatch

variability of tablet dosage forms. There is no component segregation within the granule.

2) Enhancement of the flow properties.

The flow properties of granules are both improved and more reproducible than those of mixed

powder systems and are relatively unaffected by the adsorption of low amounts of moisture

(during storage).
3) Enhancement of the compaction properties.

In comparison to powder mixes, the compaction properties of granules are improved due to the

presence of the binder component on the surface of the granules, leading to greater

intergranule adhesive interactions.

4) Lower incidence of dust production.

One problem associated with the processing of powders into tablets is possible dust production.

This problem is obviated with the use of granules.

 Description of wet granulation

Mixed powders + a suitable fluid → achieve cohesion between the powders.

The mass should be sufficiently moist to form discrete granules when sieved. If excess liquid is

added, string (filament) of material will be formed and if the mix is too dry the mass will be

sieved as powder and granules will not be formed.

Oscillating granulator

The rotor bars of the granulator oscillate and force the moist mass through the sieve screen, the

size of which determines the granule size.

Fluidised-bed granulation

 The mixed powder are fluidized by the action of

a positive (temperature-controlled) stream of air
 Whilst in this dispersed state, granulation fluid
(containing binder) is pumped from a reservoir
and sprayed from a nozzle on to the bed of
powders.
 Heated and filtered air stream is blown through
the bed of unmixed powders to fluidize the
particles and mix the powders.
 The fluid causes the primary powder particles to

adhere when the droplets and powders collide.

 Escape of material from the granulation chamber

is prevented by exhaust filters, which are

periodically agitated to reintroduce the collected

material into the fluidized bed.

 Sufficient liquid is sprayed to produce granules

of the required size, at which point the spray is

turned off but the fluidizing air continued.

 Fluidised-bed granulation

Air outlet

Exhaust
filter

Spray
nozzle
Product
containe
r

Air inlet
Granulatin
Air g liquid
filter
Stage 3: processing granules into tablets
I. Drying of the granules:
Granules are then dried to facilitate further processing.
The shelf or tray drier.
Wet granules are uniformly located on a series of horizontally arranged, shallow trays.
Air enters the drier, warmed by heaters, pass across the surface of the granules.
The moisture is then passed from the drier through an outlet.
The drying time is long. The drying efficiency of this type of system may be enhanced by the

use of a vacuum. The use of the vacuum design lowers both the time and temperature of the

drying process.

Granules may aggregate owing to bridge formation at the points of contact of the granules.
The fluidised-bed drier.

Granules are suspended in the fluidised warmed air, enabling relatively rapid drying.

Advantages:

Excellent heat transfer to granules and moisture transfer from the granules, This enables

granules to be rapidly and reproducibly dried.

Accurate control of the drying conditions e.g. airflow, temperature.

Disadvantages:

Attrition of granules whilst suspended in the warmed airflow.

Loss of particles from the drier. Avoided by means of a bag filter.

II.Milling of the granules (reduction in the granule size).
Milling of the granules to the required particle size:
• To control the particle size (and particle size distribution), which, in turn, improves both the
flow of the granules into the tablet die and the fill of the granules within the die.
• The choice of the granule size is determined by the size of the die (and hence the final tablet
size).
Oscillating granulator.
• As described previously.
Quadro Comil
• The dried granules are placed inside a conical chamber (containing a screen of defined mesh
size). The granules are then passed through the screen in a centrifugal manner by the action of
a rotating impeller, after which the granules are collected.
III.Mixing of the granules with lubricant.
The penultimate stage involves a final mixing of the dried granules with the lubricant.
Compression of the formulation into tablets.
Advantages
1) Reduced segregation of formulation components during storage and/or processing.
2) For the manufacture of tablets containing low concentrations of the drug.
3) Employs conventional excipients.
4) Tablets produced by wet granulation (possess sufficient mechanical properties) are
amenable to postprocessing unit operations, e.g. tablet-coating techniques.
Disadvantages
5) Often several processing steps are required.
6) Solvents are required in the process: this leads to a number of problems, e.g.:
Drug degradation may occur in the presence of water (avoided by alcoholic or
hydroalcoholic mixture).
The drug may be soluble in the granulation fluid. During the drying process the drug will
then crystallise, resulting in possible changes in the polymorphic form.
Degradation of thermally labile drugs during heating.
 2. Manufacture of tablets by dry granulation
In dry granulation no solvent is required; the aggregation of particles into granules is
facilitated by the application of high stresses to the mixed powders.
There are two methods by which dry granules are formed:
Slugging
 The powders are mixed and then compressed into an oversized tablet using a tableting press
that is capable of applying a high stress.
 Then the tablet is milled to produce granules of the required size.
Roller compaction
 The formulation ingredients are mixed and are then compressed using a roller compactor. In
this the powders are fed from a hopper on to a moving belt and then transported to, and
compressed by, the passage between the narrow gap between two rotating rollers to produce a
sheet of compressed material.
 The compressed sheet is then milled to produce granules of the required size (as described
previously).
 Advantages of dry granulation
1) Both roller compaction and slugging require conventional (i.e. non-specialist) grades of
excipients.
2) These methods are not generally associated with alterations in drug morphology during
processing.
3) No heat or solvents are required.
Disadvantages of dry granulation
4) Specialist equipment is required for granulation by roller compaction.
5) The final tablets produced by dry granulation tend to be softer than those produced by wet
granulation, rendering them more difficult to process using post-tableting techniques, e.g.
film coating.
6) Slugging and roller compaction lead to the generation of considerable dust. Furthermore,
there may be a reduction in the yield of tablets.
 3. Manufacture of tablets by direct compression

I. Premilling of formulation components

Excipients may be purchased to a particular particle size specification

The drug may require to be modified by milling, using a high-energy mill, the Fitzmill.
II. Mixing of drug with the powdered excipients:

Introducing all the powdered excipients and drug into a powder mixer. The types of mixers used

for this process include:

Planetary bowl mixer

Rotating drum mixers, e.g. The y-cone, cube or double-cone mixers

High-speed mixers, e.g. The diosna mixer.

III. Compression of the mixed powders into tablets

 Advantages of direct compression

1) Fewer processing steps (unit operations),

2) Potentially more cost-effective than other methods.

3) Does not require the use of water or other solvents→ avoid potential problems regarding

the stability of drugs in the presence of the solvents.

4) Heating (a costly unit operation) is not required in direct compression.

5) Lubrication is performed in the same vessel as powder mixing, thereby reducing both

transfer losses and contamination of equipment.

 Disadvantages of direct compression
1) Specialist (and more expensive) excipients are required.
2) The quality of the final dosage form is dependent on the powders being easily mixed and
remaining homogeneously mixed.
3) There may be issues regarding powder flow into the tableting machine.
4) The final tablets produced by direct compression tend to be softer than those produced by
wet granulation, rendering them more difficult to process using post-tableting techniques, e.g.
Film coating.
5) The compression properties of the powder mix are significantly affected by the compression
properties of the drug (˃ circa 10% w/w).
6) Not used if a colorant is required in the formulation due to the mottled appearance of the
resulting dosage form.
 The compression process in tableting

Stage1: the filling of the die with the granules/powders

Mixed powders or formulated granules are fed into the die section.

 The mass of solid material within this space (and hence the size of the tablet) is altered by
increasing/decreasing the position of the lower punch.
Stage 2: compression of the powder/granule bed

Stress is
applied

In general the lower punch remains static during this stage;
In addition to the choice and concentration of formulation components, changing the stress
applied to the powder/granule bed by the upper punch alters the tablet hardness.
Stage 3: tablet ejection
 Tablet defects
Three main types of tablet defect observed:
Pitting:
Refers to the production of pit marks on the surface of the tablet

Accredited to insufficient lubricant at the tablet/punch interface or

 Punches with a roughened surface.
Corrected by ↑ the concentration of lubricant in the formulation or
By altering the mixing conditions (time and rate of mixing),
Punches should be polished regularly to prevent such adhesions.
Capping and lamination:
 Refer to mechanical splitting of the tablet. In capping, the top (cap) of the tablet is fractured
whereas in lamination the fracture may occur within the main body of the tablet.

Occur during the ejection stage.

Accredited to stress-induced fracture or
Occur if the geometry of the punches is intricate
 Increase the strength of the tablets may resolve these problems. For example, the type and
concentration of the binder may be altered.
 Coating of tablets

1) To protect the drug from degradation in the stomach.

2) To prevent drug-induced irritation at a specific site within the gastrointestinal tract.

3) To provide controlled release of the drug throughout the gastrointestinal tract

4) To target drug release to a specific site in the gastrointestinal tract.

5) To mask the taste of drugs.

6) To improve the appearance of the tablet.

 Pan coater
 A metal pan into which the tablets are placed and rotated at a range of speeds.
 The solution is sprayed on to the surface of the tablets whilst the drum is rotated.
 Simultaneously warm air is passed over the surface of the tablets to facilitate the evaporation of
the solvent.
Control of the coating process is obtained by modifying the following parameters:

1) Rotation rate of the drum/pan

2) Airflow rate

3) Temperature of the air

4) Concentration of sugar/polymer within the coating solution/emulsion.

 Sugarcoating tablets:
The sugarcoating of tablets may be divided into the following steps:

Waterproofing and sealing coats

For tablets containing components that may be adversely affected by moisture, one or more
coats of a waterproofing substance, such as pharmaceutical shellac, are applied.
Subcoating
After the tablets are waterproofed if needed, three to five subcoats of a sugar-based syrup are
applied. This bonds the sugar coating to the tablet and provides rounding. The sucrose and
water syrup also contains gelatin, acacia, or PVP to enhance coating.
Smoothing and final rounding
5 to 10 additional coatings of a thick syrup are applied to complete the rounding and smooth
the coatings. This syrup is sucrose based, with or without additional components such as starch
and calcium carbonate.
Finishing and coloring

Several coats of a thin syrup containing the desired colorant are applied in the usual manner.

Imprinting

Solid dosage forms may be passed through a special imprinting machine to impart identification

codes and other distinctive symbols.

Polishing

Coating pans lined with canvas or other cloth impregnated with carnauba wax and/or beeswax

may be used to polish tablets as they tumble in the pan. Or, pieces of wax may be placed in a

polishing pan and the tablets allowed to tumble over the wax until the desired sheen is attained.
 Disadvantages

1) The sugarcoating process, is tedious, time-consuming, and

2) Specialized, requiring the expertise of highly skilled technicians

3) Also results in coated tablets that may be twice the size and weight of the original uncoated

tablets.

Film-coating tablets

1) A thin, skin-tight coating of a plastic-like material over the compressed tablet,

2) Having essentially the same weight, shape, and size as the originally compressed tablet..

3) More resistant to destruction by abrasion than are sugarcoated tablets.

4) Like sugarcoated tablets, the coating may be colored to make the tablets attractive and

distinctive.
Film-coating solutions may be nonaqueous or aqueous

The nonaqueous solutions contain the following types of materials:

1) A film former: e.g. cellulose acetate phthalate.

2) An alloying substance providing water solubility or permeability to the film to ensure
penetration by body fluids and therapeutic availability of the drug, e.g. polyethylene glycol.
3) A plasticizer to produce flexibility and elasticity of the coating and thus provide durability,
e.g. castor oil.
4) A surfactant to enhance spreadability of the film during application, e.g. polyoxyethylene
sorbitan derivatives.
5) Opaquants and colorants to make the appearance of the coated tablets handsome and
distinctive, e.g. Opaquant, titanium dioxide; colorant, FD&C or D&C dyes.
6) Sweeteners, flavors, to enhance the acceptability of the tablet by the patient, e.g.
sweeteners, saccharin; flavors, vanillin.
7) A glossant to provide luster to the tablets without a separate polishing operation, e.g.

beeswax.

8) A volatile solvent to allow the spread of the other components over the tablets while

allowing rapid evaporation to permit an effective yet speedy operation, e.g. alcohol mixed

with acetone.
Disadvantages

The expense of the volatile solvents used in the film-coating process and the environmental

problem of the release of solvents,

pharmaceutical manufacturers generally favor the use of aqueous solutions.

One of the problems attendant to these, however, is slow evaporation of the water base

compared to the volatile organic solvent–based solutions.

A typical aqueous film-coating formulation contains the following:

1) Film-forming polymer: cellulose ether polymers such as HPMC, HPC, and MC.

2) Plasticizer: glycerin, propylene glycol, PEG, diethyl phthalate, and dibutyl subacetate.

3) Colorant and opacifier: FD&C or D&C lakes and iron oxide pigments.

4) Vehicle (water, to make 100%).

Characteristics of types of tablet coatings
 The desired features for pharmaceutical tablets

1) The tablet should include the correct dose of the drug.

2) The appearance of the tablet should be elegant, and its weight, size and appearance should be

consistent.

3) The drug should be released from the tablet in a controlled and reproducible way.

4) The tablet should be biocompatible.

5) The tablet should be of sufficient mechanical strength to withstand fracture and erosion

during handling at all stages of its lifetime.

6) The tablet should be chemically, physically and microbiologically stable during the lifetime

of the product.

7) The tablet should be packed in a safe manner.

 Quality control

Tablet weight and USP weight variation test:

o Collecting a sample of tablets from a batch and determining their individual weights.
o Calculation the average weight of the tablets.
o The sample complies with the standard if the individual weights do not deviate from the mean
more than is permitted in terms of percentage.
Drug Content Uniformity:
Collecting a sample of tablets
Determination of the amount of drug in each tablet.
Calculation the average drug content
The content of the individual tablets should fall within specified limits.
Unless otherwise stated in the monograph, the requirements for content uniformity are met if the
amount of active ingredient in each dosage unit lies within the range of 85% to 115% of the label
claim and the standard deviation is less than 6%.
Tablet Thickness:

for tablets of uniform thickness and hardness, it is doubly important to control pressure. Tablet

thickness may be measured by hand gauge during production or by automated equipment

Tablet Hardness :
o Lozenges and buccal tablets, that are intended to dissolve slowly → made hard;
o Immediate drug release, → made soft.
o Tablets should be sufficiently hard to resist breaking during normal handling and yet soft
enough to disintegrate properly after swallowing.
o Measure the degree of force (in kilograms, pounds, or in arbitrary units) required to break a
tablet.
o A force of about 4 kg is minimum requirement for a satisfactory tablet.
Friability:
o A tablet’s durability may be determined through the use of a friabilator.
o It determines the tendency to crumble, by allowing it to roll and fall within the drum. The
tablets are weighed before and after a specified number of rotations and any weight loss is
determined. Resistance to loss of weight indicates the tablet’s ability to withstand abrasion in
handling, packaging, and shipment.
o A maximum weight loss of not more than 1% generally is considered acceptable for most
products.
 Table (1): Evaluation of The Different Prepared GHBTs:
Thickness Hardness
Formula No Weight (mg)a % Friability % Drug Content b
(mm)a (Kg)a
F1 101.01±0.72 2.02±0.05 5.51±0.19 0.49 100.33±2.68
F2 102.58±0.56 2.06±0.06 3.36±0.16 0.99 98.32±1.45
F3 101.66±1.23 2.04±0.04 4.73±0.14 0.69 98.66±1.26
F4 102.66±1.08 2.1±0.07 5.45±0.16 0.78 102.45±0.95
F5 103.76±0.63 2.16±0.08 3.47±0.13 0.58 98.99±0.15
F6 104.02±0.49 2.22±0.3 4.55±0.15 0.48 97.87±1.23
F7 102.86±0.71 2.04±0.05 5.76±0.15 0.88 96.98±0.78
F8 104.21±0.37 2.27±0.19 3.37±0.16 0.77 95.64±0.69
F9 104.00±0.51 2.16±0.11 4.53±0.32 0.38 101.11±0.94
F10 101.72±1.05 2.0±0.05 5.50±0.11 0.59 98.99±1.01
F11 102.84±0.72 2.03±.04 3.30±0.24 0.89 99.44±1.24
F12 102.46±1.11 2.02±0.13 4.45±0.14 0.61 101.01±0.63
F13 103.672±0.65 2.19±0.10 5.45±0.21 0.67 96.42±1.26
F14 104.26±0.52 2.25±0.13 3.32±0.17 0.96 99.10±0.36
F15 103.82±1.04 2.19±0.12 4.61±0.10 0.68 97.20±0.88
F16 102.55±0.98 2.04±0.06 5.52±0.07 0.79 95.31±0.36
F17 103.66±0.51 2.20±0.14 3.40±0.19 0.69 96.76±1.41
F18 104.00±0.51 2.26±0.07 4.77±0.09 0.77 97.09±0.48
F19 103.42±0.92 2.24±0.08 4.98±0.10 0.39 100.66±0.97
F20 103.95±0.82 2.21±0.12 5.14±0.15 0.95 101.21±1.54
a: Each value represents the mean ±SD (n=5), b: Each value represents the mean ±SD (n=2).
Tablet Disintegration

 Complete disintegration is defined as “that state in which any residue of the unit, except

fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus

is a soft mass having no palpably firm core”

 Tablets must disintegrate within the times set forth in the individual monograph, usually

30 minutes, but varying from about 2 minutes for nitroglycerin tablets to up to 4 hours for

buccal tablets.
Dissolution

The process by which solid substances enters in solvent to yield a solution. it

is controlled by the affinity between the solid substance and the solvent.

Importance of dissolution testing:

Dissolution testing is useful method for :

Ensuring the establishment correlation between dissolution rate and

extent of absorption (bioavailability).

Quality control: monitoring the formulation and manufacturing process.

Establishing intrinsic dissolution rate which is useful in screening new

materials being considered for new drug application.

 Packaging and storing tablets

Tablets are stored in tight containers, in places of low humidity, and protected from extremes in

temperature.

Products that are prone to decomposition by moisture generally are packaged with a desiccant

packet. Drugs that are adversely affected by light are packaged in light-resistant containers.

With a few exceptions, tablets that are properly stored will remain stable for several years or

more.