1.

Tablet coating is a process of applying film of materials on the surface of

pharmaceutical tablets to achieve special benefits. The amount of coating on the
surface of a tablet is critical to the effectiveness of the oral dosage form. This is an
additional process in tableting which causes an increase in the cost of tablet
production.
2. When a coating solution is applied to a batch of tablets, the surfaces of the tablets
get covered with a tacky polymeric film. The tablets are then allowed to dry using
suitable means and the film eventually forms a non-sticky dry surface.
3. The coating technique involves parameters such as the spray pattern, drop size,
and nozzle spacing etc. All these parameters must be precisely controlled in order
to ensure uniform distribution of the coating material.
Objectives of Coating:
The objectives of tablet coating are as follows:
1. To improve aesthetic quality of product by incorporating special colors
and contrasting printing.
2. To mask the disagreeable odor, color or taste of the tablet.
3. To offer a product stability through physical and/or chemical protection
to the drug.
4. To control and sustain the release of the drug from the dosage forms.
5. To incorporate another drug that may create incompatibility issues.
6. To protect an acid-labile drug from the gastric environment.
7. Increasing the mechanical strength of the dosage form.
8. Increasing the ease to swallow by the patient.
9. Facilitating handling, particularly in high-speed filing/packaging lines
 Types of Tablet Coating

Sugar coating
Film coating
Enteric coating
Compression coating
Sugar coating :
1. Sugar coating was one of the earliest methods. This process is still
widely used in the confectionery industry.
2. In sugar coating tablets are suspended by air and a coating solution is
introduced into the air stream.
3. Sugar coating of a tablet offers a sweet coat mainly made from
polysaccharides and sucrose to obscure the bitter taste of the tablet.
4. The sugar coating also offers a sweet aroma especially on foul
smelling pills like fish supplements.
5. The sugar syrup is coated on the tablet surface and the water is left
to evaporate from the syrup leaving a sugar coat. Sugar coat covers
tablets with a sugar layer that can either be colored or uncolored.
6. Sugar coating adds a weight to the tablet by 30%.
7. This coating is soluble, masks bad taste, acts as a protective layer and
enhances appearance.
8. The coating results in a highly flavored and shiny tablet. Sugar coated
tablets are prepared especially for kids.
Film coating:
1. Film coating is the most commonly used coating in the
pharmaceutical tablet manufacturing today. Most drug
manufacturers are switching to Film coating.
2. It is basically the process of adding a very thin layer to tablets. This
coating gives aesthetic look and improves the taste of the pill.
3. Tablets especially those from herbal extracts are not visually
pleasing, therefore a coating is necessary for beautifying the tablet
using different colors.
4. In other cases not all tablets need a coat, just a film to maintain its
original color.
5. Spraying is used to create an even film around a tablet. Film coating
produce a stable and strong tablet.
6. Film coating process is easy to atomize, involves few procedures and
increases the overall weight of tablets by only 3%.
7. lt can be useful in tablet branding with colors and identifiable
coatings.
Enteric coating:
1. This coating provides a stomach acid resistant coat for the tablets that
have an ingredient that is sensitive to acid.
2. If a tablet is to be absorbed in the small intestine, therefore there is
need for the tablet to withstand stomach acid and reach the targeted
area where it is absorbed slowly where there is no acidity.
3. This type of tablet need not be crushed or chewed to prevent the risk
of damage due to a reaction with stomach acid.
4. This coating helps to deliver the tablet to intestine without damaging
effects to the drug.
Compression coating:
1. Most drugs that are compression-coated contain two insoluble
materials separated into two parts.
2. The outer coat is typically a water-soluble sugar compound and
dissolves after swallowing.
3. The internal core usually contains an enteric coating that allows for a
second drug release during a later digestive stage.
4. The internal core may be liquid to allow for simultaneous release with
the outer coat. It involves compaction of granular particles around a
preformed tablet using special equipment through a dry process.
Coating Materials:
1. Tablet coating materials are a mixture of solids and liquids. For many
years, the liquid component of coatings was a volatile solvent, such
as alcohol or other quick-drying substances like methylene chloride.
2. While solvent-based coatings performed well in many respects, they
presented problems in handling, operator safety, recovery, and odor'
3. They could even make the finished tablets smell like solvent, which
is not a desirable side effect. Solvent-based coatings are still used in
some applications, but water based, or aqueous, coatings have
largely replaced them.
Composition for sugar coating:
1. sugar coating consists of in all coats and thus the compositions too
are different. The seal coat is composed Shellac and zein.
2. Sub coat Consists of solutions gelatin, acacia, sugarcane and
powders of kaolin, dextrin, starch, acacia
3. Final syrup coat is comprised of suspended powders, sucrose syrup
and dilute colorants.
Composition for film coating:
Film coating is characterized by application of an excipients suspension
formulation, consisting of polymer, plasticizer, colorant, and solvent
directly onto the tablet.
The purpose of each ingredient is either around safety and feasibility for
industrial production or stability and taste for the consumer.
These compositions may be non-aqueous or aqueous.
A) Non-aqueous Coating Formulation
Type Function Examples

Film former To produce smooth and thin films that are Cellulose acetate
reproducible under conventional coating phthalate
conditions and are applicable to a variety of
tablet shapes.
Alloying Provides water solubility or permeability to Poly ethylene
agent the film to ensure penetration by body glycol
fluids and therapeutic availability of the
drug.
Plasticizer To produce flexibility and elasticity to the Castor oil
coating and thus provide durability.
Surfactant To enhance the spreadability of the film Poly oxyethylene
during application. sorbitan
derivatives
 Type Function Examples

Opaquant To make the appearance of the coated tablets Titanium oxide, FD

and handsome and distinctive. & C or D & C dyes
colorants
Sweeteners, To enhance the acceptability of the tablet to Saccharin, vanillin
flavors the patient.
and aromas
A glossing To provide luster to the tablets without a Bees wax
agent separate polishing operation.
Volatile To allow the spreading of the other Alcohol mixed with
solvent components over the tablets while allowing Acetone
rapid evaporation to permit and effective yet
speedy operation
A commercial water based colloidal coating dispersion called aqua ethyl
cellulose. Usually use of aqueous solution is favored compared to
solvent based solutions. coat contains 30% the volatile organic

B) Aqueous Coating Formulation

Type Function Examples

Film forming To produce smooth, thin films on surface of Cellulose ether

polymer variety of tablet shapes. polymers such as
(71.8%) HPMC, HPC, MC

Plasticizer To induce flexibility and elasticity to the Glycerin, propylene

(0.52%) coating that provide durability. glycol,
PEG, Diethyl
phthalate
 Type Function Examples

Colorant and To make attractive appearance of the FD & C or D & C

opacifier coated tablets. lakes and
(2.5 8%) iron oxide
pigments

Solvent to To allow the spread of the other Water

make components over the tablets
I00%
Composition for enteric coating:
Usually enteric coating compositions contains four polymers.
a) Cellulose acetate phthalate:
• It is hygroscopic and relatively permeable to moisture and gastric
fluids. The films of this polymer are brittle and usually formulated
with hydrophobic film forming materials to achieve a better enteric
film.
• Aquateric coating, a FMC corporation patented aqueous enteric
coating composition is a reconstituted colloidal dispersion of latex
particles composed of solid and semisolid polymer spheres of this
polymer ranging in size from 0.05 to 3 microns with an average
particle size of 0.2 p is most commonly used.
b) Acrylate polymers:
• It is available in two forms as Eudragit L and Eudragit S. Both these
polymers produce films that are resistant to gastric fluid. Eudragit L is
available as an organic solution (isopropanol).
• whereas solid or aqueous dispersion of Eudragit S is available only as
an organic solution and solid.
c) Hydroxy propyl methyl cellulose phthalate:
• This polymer is quite stable because of absence of labile acetyl
groups.
• It dissolves at a lower pH (5.5) which may result in higher
bioavailability of some specific drugs
d) Poly vinyl acetate Phthalate:
• It is manufactured by esterification of a partially hydrolyzed polyvinyl
acetate with phthalic anhydride, It has good stability and pi
dependent solubility.

Composition for compression coating:

•Most tablets that are compression-coated contain two insoluble drugs
separated into two parts.
•The outer coat is typically a water soluble sugar compound and
dissolves after swallowing; the internal core usually contains an enteric
coating polymer that allows for a second drug release during a later
digestive stage.
 EXCIPIENTS USED IN TABLET COATING COMPOSITIONS

1. Solvent:
• The solvent system should easily disperse or dissolve the polymers and
other coating solution components.lt should be colorless tasteless odorless,
inexpensive, non-toxic, inert and non-inflammable and should have a rapid
drying rate.
• Most importantly it should have no environmental impact. The most widely
used solvent system consists of solvents either alone or in combinations.
• Drugs that readily hydrolyze in the presence of water can be more
effectively coated with non-aqueous solvent based coatings.
Examples: Water, ethanol, methanol, isopropanol, chloroform, acetone,.
Methylene chloride. Water is the solvent of choice.
Plasticizers:
The quality of the film can be modified by employing plasticizers, They
are incorporated in composition by internal or external plasticizing techniques.
Internal plasticizing: involves chemical modification of the basic polymer that
alters the physical properties of the polymer.
The external plasticizers :are added as additives to the coating solution
formula so that desired effects are achieved for the film. An external plasticizer
can be a non-volatite liquid or other polymer which when incorporated with
primarily polymeric film former changes the flexibility, tensile strength or
adhesion properties of the resulting film.

Example:Castor oil, propylene gl!rco[ glycerin low molecular weight PEG,

surfactants polysorbates (tweens), sorbitan esters (spans) and organic esters.
Aqueous coating plasticizers are PEG and propylene glycol while for organic
solvent solutions castor oil and spans are used.
Colorants:
•Colorants are synthetic dyes or lakes of dyes. Lakes are derived from
dyes by precipitating with carriers such as alumina or talc.
Lakes have become the colorants of choice for sugar or film coating
systems.
•Concentration of colorants in the coating solution depends on the color
shade desired, the type of dye and the concentration of the opaquant
extenderc.
• If a very light colour is desire{ <0.0L% may be adequate but if dark light
is desired >2% is used.
Example:Inorganic materials (iron oxide), natural coloring materials
(anthrocyanins, caramel, chlorophyll. turmeric) etc.
Opaquant Extender:
Opaquant extenders are very fine inorganic powders used in the
coating solutions to provide more paste colors and increase film
coverage.
The opaquants provide a white coating or mask the color of the tablet
core.
Example: Titanium dioxide talc, aluminum silicate, magnesium
carbonate, calcium sulfatg magnesium oxide, aluminum hydroxide.
Flavors and sweetener: Flavors and sweeteners are adequate to mask
the unpleasant taste of tablets.
Both natural and artificial flavors are used at concentrations lower than
3 %.
Natural flavors tend to offer better taste, but artificial flavors are easier
to characterize and are more chemically stable.
Example: Natural sweeteners such as mannitol, dextrose, and xylitol at
40 to 70% provide body and texture to the tablets, while artificial
sweeteners such as sodium saccharin, aeesulfame potassium,
aspartame, and sucraose at <1% provide an intense sweet taste at this
lower concentrations.
Surfactant: These are used to solubilize immiscible or insoluble
ingredients or to facilitate faster dissolution of the coating.
Example: Poly oxyethylene sorbitan derivatives.
Antioxidants: These are incorporated to stabilize a dye system to
oxidation and color change.
Example: Ascorbic acid and their estert sodium bisulphate, thiourea,
butyl hydroxy toluene (BHT); alpha.tocopherol, ethyfene diamine tetra
acetic acid etc.
Antimicrobial agents: These are added to prevent microbial growth in
coating composition during its preparation and its storage on the coated
tablets.
Examples: Benzyl alcohol, butyl paraben, phenol, thiomersal, vitamin A, vitamin E, vitamin
C retinyl palmitate, and selenium etc.
Standard Coating Pan:
1. Standard coating pan is also known
as the conventional pan system and
is a popular accessory in
manufacturing of coated tablets in
majority of pharmaceutical
industries.
2. conventional tablet coating pan and
consists of a circular metallic pan
with a diameter of between 6-80
inches.
3. The pan is slightly tilted to an angle of
about 45' to the bench top stand. The
standard coating pan has an electric motor
that rotates the circular metal pan
horizontally to its axis.
4. It is the motion of this pan that causes a
batch of tablets to tumble.
5. In addition, it has an inlet port to supply
hot air that dries the coating solution.
6. A batch of tablets is loaded into the pan
which is set to rotate.
7. Coating solution is applied to the
rotating tablet bed by spraying in
atomized form which can produce a
faster and more even distribution than
simply introducing it as a liquid.
8. It is important to ensure that the air
temperature does not initiate any
chemical reaction on the tablets from
the tableting machines.
9. Very high temperature may decompose
or degrade essential chemical
constituents of the tablets.
(B) Perforated Coating Machines:

1. Perforated coating pan is also popular among many

pharmaceutical companies.
2. In most cases, this type of tablet coating equipment has either
a full or partial perforated drum.
3. Like the standard coating pan, the drum of this tablet coater
rotates on a horizontal axis.
the drum of this tablet
coater rotates on a
horizontal axis.
the coating drum is an enclosed
housing with various spray
nozzles.
It is these spray nozzles that
atomize the coating solution.
However, unlike most
conventional pan machines,
perforated pan coaters have an
efficient drying system.
Besides, they are high capacity
tablet coating machines.
This type of tablet coating systems are further classified in
to the following types.

•Accela-cota system
•Dria coater pan
•Hi coater system
•Glatt coater
Accela-cota system: There are a
number of processes that take
place within the drum of accela-
cota machine

There are a number of processes that take place within the drum.
1. Baffles ensure the tablets mix freely within the drum as it rotates
2. Spray gun atomizes the coating solution and directs it to the tablets
3. Dry inlet air flows from the upper section of the drum, passing in
between the tablets. It leaves the drum through the perforations.
This increases the overall efficiency of this type of tablet coating
machine.
 b) Dria Coater Pan
When you look at the figure
below, the difference between
accela-cota system and dria
coater pan is quite clear.

1. A dria coater pan has hollow perforated ribs, which are locate
on the inside periphery tablet coating drum.
2. Therefore, as the drum rotates, the spray nozzle atomizes
coating solution and directs it to the tablets from the top
section.
3. However, the drying air enters the coating drum from below the
tablets and flows upwards, then exits the system through the back of
tablet coating pan.
4. Remember, this is not the case in the accela-cota.
5. Basically, in dria coater, the drying air fluidizes the tablets. You can
see the tablets suspended in air.
c) Hi-coater System
Although the design of hi-coater systems may be different, the working
principle is similar to that of the accela-cota.

The machine directs both the

coating solution and drying air into
the centre of the drum downwards.
The drying air then leaves the
coating system through the
perforations
below the coating drum
 A rotary disc valve in the technical
area of the coater controls channeling
of the exhaust air by maintaining a
constant cross-section of the exhaust
air channels.
Drum inner wall is partially
perforated to avoid product damage.

Coating drum outer wall is fully enclosed. Removable housing front

provides optimum accessibility of 30 - 100% of the working capacity of
the coater.
d) Glatt Coater
The design of a Glatt coating pan machine resembles that of the accela-
cota.
This type of tablet coating machine is known for:
•High spray rates
•Extremely short processing time
1. Its design is such that the drying air from inside the tablet coating
drum.
2. Normally, the air passes through the tablet bed and leaves via
exhaust duct.
3. Its unique design minimizes turbulence that may occur around the
spray nozzle.
4. This ensures an even distribution of the coating solution on the
tablets.
1. The working principle of all these tablet coating machines is the
same in all the perforated pan systems, the spray nozzle atomizes
coating fluid. Also, the spraying nozzle is in the tablet coating drum.
2. The only difference is how the machine supplies and removes the
drying air.
3. its drum has unique geometrical shapes with baffles on the
periphery. This ensures an effective mixing of tablets while
protecting them from damage, at the same time it ensures a very
even and exceptionally high-quality coating.
4. its drum has unique
geometrical shapes with baffles
on the periphery. This ensures
an effective mixing of tablets
while protecting them from
damage, at the same time it
ensures a very even and
exceptionally high-quality
coating.
This is one of the tablet coating machines that provides consistent
and accurate coating.
Fluidized Bed Coater

The working principle of fluidized bed or air suspension

system is basically similar to that of the other spraying
systems.
Normally, the key aspects about these coating machines are:
•It has a vertical cylinder
•A column of drying air flows upwards suspending all the tablets.
This causes the tablets to move upwards, outwards and then
downwards, a process we refer to as fluidization.
•Spray nozzle atomizes and introduces the coating fluid into a
fluidized bed. The nozzle’s position can either be at the top or
bottom of the fluidized bed coater.
This process will continue until you achieve the right coating on
your tablets.
The degree of coating using fluid atomization in all above machines
depends on the type, design and size of the nozzle, fluid pressure and
orifice size. There are two principal arrangements used in fluidized bed
coater to apply finely divided spray coating solutions to tablets:

High pressure airless system: Airless spray liquid is pumped at high

pressure (1.7 to 20 MPa or 250 and 30@ psig) through a small orifice
(0.02 to 0.2 mm dia.), which results in to a finely divided spray. The
degree of atomization and spray rate are controlled by fluid pressure,
liquid viscosity and orifice size.
Low pressure air atomized systems: The liquid in this case is
pumped through a larger orifice (0.05 to 2.5 mm dia.) at a
relatively low pressure (35 - 350 kpa or 5 to 50 psig).
The low pressure air contacts the liquid stream at the top of the
atomizer and a finely divides the spray. The degree of atomization
is controlled by the fluid cap orifice, fluid viscosity and fluid
pressure, as well as air cap design and air pressure.
 Air Suspension Techniques (Wurster)

(FLUIDISED BED COATING )

▪ Inventions of Professor Dale E. Wurster

▪ Basically the wurster process consists of the dispersing of solid,
particulate core materials in a supporting air stream and the spray-coating
of the air suspended particles.

▪ Equipment ranging in capacities from one pound to 990 pounds.

▪ Micron or submicron particles can be effectively encapsulated by air
suspension techniques.
❑ Within the coating chamber, particles are suspended on an upward
moving air stream.

❑The design of the chamber and its operating parameters effect a

recalculating flow of the particles through the coating zone portion of the
chamber, where a coating material, usually a polymer solution, is spray
applied to the moving particles.
 The Wruster Process
This technology is characterized by the
location of a spray nozzle at the bottom of
a fluidized bed of solid particles.
The particles are suspended in the
fluidizing air stream that is designed to
induce a cyclic flow of the particles past the
spray nozzle.
The nozzle sprays an atomized flow of
coating solution, suspension, or other
coating vehicle.
The technology can be used to encapsulate
solid materials with diameters ranging from
near 50µm to several centimeters.
Wruster Process can be used to
encapsulate vitamins, minerals, and
functional food ingredients.
 Air suspension techniques
(WURSTER PROCESS):
• It consist of dispersing the solid particulate core material in supporting air
stream and being coated with coating material (usually polymeric solution)
• In this, the fine core materials are suspended in a vertical current of air and
sprayed with the coating material
• After evaporation of solvent, a layer of encapsulating material is deposited
on core
• Gives improved control and flexibility as compared to pan coating.
• During each pass through the coating zone, the core material receives an
increment of coating material.
• The cyclic process is repeated, perhaps several hundred times during
processing, depending on the purpose of microencapsulation the coating
thickness desired or whether the core material particles are thoroughly
encapsulated.
• The supporting air stream also serves to dry the product while it is being
encapsulated.
• Drying rates are directly related to the volume temperature of the
supporting air stream.
31
▪ Disadvantage- Agglomeration of the particles to some larger size is
normally achieved.

variables for efficient, effective encapsulation by air suspension

techniques:
1. Density, surface area, melting point, solubility, friability,volatility,
Crystallinity and flow-ability of core the core material.
2.Coating material concentration (or melting point if not a solution).
3.Coating material application rate.

4. Volume of air required to support and fluidizes the core material.

5.Amount of coating material required.
6.Inlet and outlet operating temperatures.
 Tablet Coating Problems and their Solutions in
Pharmaceuticals

1. Coating tablets with a thin polymer film can be an effective

way to give products a professional edge.
2. High quality tablets can be quickly and easily produced using
a tablet coating machine and the proper excipients.
Unfortunately, several defects can arise while coatings.
Following is the list of defects encountered with tablet coating
and reasons causes and remedies for the same.
(i) Blistering:
The blistering in tablet coating is a local
detachment of film from the substrate
forming blister, occurs when its
elasticity or adhesive properties are
compromised leading to film detached.

Reason: Entrapment of gases in or underneath the film due to over heating

either during spraying or at the end of the coating run.
Cause: Blistering is usually a result of high temperatures that may occur during
the drying process, during the spraying stage or at the end of the coating
process. It directly affects the strength, elasticity and adhesion of the film.
Remedy: Use of mild drying conditions, and ensuring moderate temperatures
at other stages of the coating process.
Cratering
It is a coating defect of the film where
volcanic-like craters appear on the tablet
surface. In other words, it is a defect in the
film’s coating results in craters appearing on
the tablet which in turn results in the
exposure of the tablet’s surface.
Causes Remedies

Penetration of coating solution at the Decrease the spray rate and use optimum
surface of the tablet, often at the crown drying conditions.
where the surface is more porous causing
localized disintegration of the core.
Inefficient drying. Use optimum drying conditions.

Application of higher rate of the coating Decrease spray application rate.

solution.
Low the viscosity of the coating solution.
Increase viscosity of coating solution.
Sticking and Picking
It is a coating defect where part of film of
tablets momentarily stick together or stick
to the pan, often just after they pass
through the spray zone, and then sticked
area being detached from the tablet
surface.
Cracking/Splitting :It is a coating defect in which the film either cracks across
the crown of the tablet (cracking) or splits around the edges of the tablet
(Splitting).
Color variation
It is a coating defect that involves variation in color of the film. In other words,
color variation is a coating defect where visible differences in color of film
found from tablet to tablet.
Chipping/ Edge Erosion: a common tablet coating defect
It is a coating defect where the film becomes chipped or worn away and dented
usually at the edges of the tablet as the coating is being applied.
Core Erosion/ Surface Erosion
It is a coating defect where tablet surfaces erode as tablets tumble during the
coating process. Especially this problem has happened with the presence of
inappropriate logo.
Discoloration
It is a rare coating defect where discoloration is appeared either through or on
the coating caused by interactions of ingredients in the core or by heat from the
process causing ingredients in the core to migrate through the coating. The
problem is commonly seen with nutraceutical products.
Logo Bridging
It is a coating defect where coating bridges formed across a logo or break line.
As more coating is applied to tablet surfaces, the stresses that develop within
the coating as it dries overcome the forces of attachment of the coating to the
tablet surface, causing the coating to pull away within the logo or break line,
making either less visible
Orange Peel (Roughness)
It is a coating defect where the surface of the applied film coating is extremely
rough and nonglossy, often taking on the appearance of the skin of an orange.
Pitting
It is a coating defect where pits appear on the surface of a tablet core without
any visible disruption of the film coating. In other words, pitting is the
deformation of the core of the tablet without any visible signs of disruption of
the film coating.
Peeling
It is a coating defect where peels off the tablet during or after the coating
process. Peeling refers to the formation of uneven or rough irregularities on the
surface of a coating film applied on a core tablet surface.
Scuffing of Film-coated Tablets
It is a coating defect in which gray to black marks on the surface of white (or
lightly colored) film-coated tablets appear. Scuffing is appeared when tablets
are more sliding rather than trembling.
Tablet Breakage
It a defect where tablets break apart during pan loading or while tumbling in
the pan or during the coating process, or during unloading of the coating pan.
 Quality Control Tests for Coated Tablets
Pharmacopoeial or Official tests
1.Content of Active Ingredient/ Absolute drug content test
2.Uniformity of Weight
3.Uniformity of Content
4.Disintegration time test
5.Dissolution test
Content of Active Ingredient
1. This is determined from a sample of 20 tablets which should be randomly
selected from a batch of tablets. The tablets are weighed together and are
crushed in a mortar with a pestle.
2. An amount equivalent to the theoretical content of each tablet or the
average of the crushed tablets is weighed out in an analytical balance.
3. The weighed powder is dispersed in a solvent in which the active drug is
freely soluble or in a solvent prescribed in the individual drug monograph.
4. This is filtered and an aliquot of the resultant filtrate is subjected to the
stipulated assay procedures. The assay procedures are usually given in
the individual drug monograph.
5. the results obtained here gives the average content of 20 tablets
Uniformity of Weight/ Weight variation test:
The test for uniformity of weight is performed by weighing individually 20
tablets randomly selected from a tablet batch and determining their
individual weights. The individual weights are compared with the average
weight
Uniformity of Content
Content uniformity test was developed to ensure content consistency of active
drug substances within a narrow range around the label claim in dosage units.
By the USP method, 30 tablets are randomly selected, 10 of these tablets are
assayed individually according to the method described in the individual
monograph. Unless otherwise stated in the monograph, the requirements for
content uniformity are met if the amount of active ingredient in nine (9) of the
ten (10) tablets lies within the range of 85% to 115% of the label claim. The
tenth tablet may not contain less than 75% or more than 125% of the labelled
drug content.
If one or more dosage units do not meet these criteria, the remaining 20 tablets
are assayed individually and none may fall outside of the 85% to 115% range
for the batch to be accepted.
 Disintegration Time Test

All USP tablets must pass a test for disintegration, which is conducted in
vitro using a disintegration test apparatus. The apparatus consists of a basket-
rack assembly containing six open-ended transparent tubes of USP-specified
dimensions, held vertically upon a 10-mesh stainless steel wire screen.
During testing, a tablet is placed in each of the six tubes of the basket, and
through the use of a mechanical device, the basket is raised and lowered in a
bath of fluid (e.g. water, or as prescribed in the individual drug monograph) at
29 to 32 cycles per minute, the wire screen always below the level of the fluid.
For most normal release tablets, the time permitted is 15 minutes
Dissolution Test
 Non-Pharmacopoeial or Non-Official Tests

Tablet Hardness or Crushing Strength Test

Friability Test
Tablet Thickness