UNIT II

A. TABLETS
Dr. Altaf
 CONTENTS
⚫ Introduction
⚫ Classificationof Tablets
⚫ Excipients used in Formulating Tablets
⚫ Tablet Granulation & Its Importance
⚫ Methods of Granulation
⚫ Tablet Compression Machines
⚫ Equipment tooling
⚫ Compression Processing Problems during
Tablet Manufacturing Process
 INTRODUCTION
Pharmaceutical Tablets :- are solid dosage
forms containing one or more drugs with or
without the addition of excipients.
⚫ Addictives or excipients are
incorporated mainly to enhance physical
appearance,
stability, disintegration, or breakup of tablet after
administration.
⚫ According to Indian Pharmacopoeia,
pharmaceutical tablets are flat or bi-convex
discs manufactured by compressing a drug or
a mixture of rugs with or without suitable
excipients.
 Ideal Characteristics of Tablets
The objective of the design and manufacture of the
compressed tablet is to deliver orally the correct amount of
drug in the proper form, at or over the proper time and in the
desired location, and to have its chemical integrity protected.
⚫ Should be an elegant product, free from defects.

⚫ Should have strength to withstand the harshness of

mechanical shock that can be encountered in its production,
packaging, shipping etc.
⚫ Must be able to release the medicinal agent in the body in a

predictable and reproducible manner.

⚫ Must be uniform in weight and drug content.

⚫ Size and shape of tablets influence the passing of product

through GIT.
⚫ Tablets should be physically and chemically stable so that no

alternation of Active ingredient with time.

 Advantages of Tablets
 Cheapest oral dosage form, easy to
convenient to administer and offers handle,
precision. greatest
 Have the best combined properties doseof chemical,
mechanical, and microbiological stability of all the
oral forms.
 Greatest ease of swallowing, and less shelf storage
space.
 Suitable for large scale production
 Unpleasant and bitter tasting drugs when
formulating, the taste can be masked with excipients
suitable.
 Provide protection of medicaments from
 Disadvantages of Tablets
 Some of drugs, due to their highly amorphous
nature and low density, are difficult to compress.
 Chances of loss of ingredients of tablets during
manufacturing because of involvement of several unit
of operation.
 Drugs with poor wetting properties and slow
dissolution rate are difficult to be dispensed in the
form of tablets.
 Drugs with objectionable odour and bitter tasting
substance need special treatment for compression.
This can increase the cost of production.
 Bioavailability problems may arise due to slow
disintegration and slow dissolution
 Some drugs can cause irritant effect on the GIT.
 CLASSIFICATION OF
TABLETS

4 MAJOR TYPES

TABLETS
ORALLY GIVEN
INGESTED THROUGH
TABLETS OTHER
ROUTES
TABETS FOR TABLETS TO
ORAL PREPARE
CAVITIES SOLUTIONS
 ORALLY INGESTED TABLETS

Compressed Enteric Coated

tablets Tablets

Multiple
Film Coated Tablets
Compressed Tablets

Sugar Coated
Chewable Tablets
Tablets
 Majority of the tablets are ingested orally. These
tablets are swallowed intact along with a sufficient
quantity of water.
⚫ Compressed tablets – prepared by
powdered crystalline compression f granular
materials, by the
or
application of high pressures using punches and die. They
do not contain any special coating. Here rapid
disintegration occurs which releases the drug rapidly.
⚫ Multi - compressed tablets – composed of 2-3 layers.

Prepared by introducing the fill material to more than one

compression cycle. Multi compression is done in cases
where the ingredients are physically or chemically
incompatible or when a prolonged action is required. They
are further classified into 3 : - compression coated tablets
:- layered tablets
:- inlay tablets
Compression coated tablets – consists of 2 parts –
internal core (the tablet) and surrounding coat.
These tablets are prepared by filling coat material to
half, core tablet is mechanically transferred, again
remaining space is filled with coat material, and
finally compression force is applied.
Inlay tablets – tablet core is not completed
surrounded by the coating, top surface is completely
exposed. Prepared by filling the die with coating
material and mechanically placing the core in the
die, the compressed. Coat is displaced to form the
sides.
Layered tablets - consists of 2 -3 ingredients in
layers. Preferred when 2 or more ingredients have to
be administered simultaneously.
Compression coated tablets
Layered tablets

Inlay tablets
⚫Enteric – formulated to prevent drug
tabletsin the stomach. Such an enteric coating is
release
preferred when the drug gets inactivated or
destroyed by gastric pH, or when drug is irritating to
the gastric mucosa. Enteric coat is insoluble in the
acidic pH and soluble in the alkaline pH. Such
tablets are also meant for delayed release.
Enteric coating materials – polymers like Cellulose
acetate phthalate, hydroxypropylmethylcellulose.
⚫ Sugar coated tablets – contain concentrated sugar

solution coating. Used to improve patients

compliance, increase physical appearance, mask
unpleasant taste, increase the stability or modify the
release of the drug.
⚫ Film coated tablets – are tablets coated with a
thin layer of polymer material or a mixture of
polymer materials. The coating is designed to
break the core tablet at the desired location in the
GIT. Film coating also protects the tablet from
atmospheric effects.
⚫ Chewable tablets – are chewed prior to
swallowing, useful for children or adults who
have difficulty with swallowing the tablet intact.
Substances like mannitol, dextrose are used in
the preparation along with the active ingredient.
These tablets do not require any disintegrating
agents. They should also have an acceptable taste
and flavour.
 TABLETS FOR ORAL CAVITIES

Buccal and Lozenges and

Sublingual Tablets Troches

Dental Cones
Oral cavity includes lips, cheeks, teeth, gums,
floor of the mouth, bony roof of the mouth,
and two thirds of the tongue.
⚫ Buccal and Sublingual tablets – small and flat
oval tablets.
Sublingual administration – placing drug under
the tongue to dissolve and absorb into the blood.
Buccal administration – placing a drug between
gums and cheek to dissolve and absorb into
blood
⚫ Lozenges and troches– disc shaped with
medicinal agents incorporated in flavoured hard
candy or sugar base. Intended to be dissolved
slowly in the oral cavity
⚫ Dental cones - are compressed tablets which

are placed in the empty sockets after tooth

extraction to prevent attack of bacteria or
 Buccal
Tablets

Sublingua
l
Tablets

Dental
Cones
TABLETS GIVEN BY OTHER ROUTES

Implantation Vaginal tablets

Tablets
⚫ Implants – long acting sterile tablets which are
designed to provide continuous release of drugs
for the months or a year. Placed under the skin or
inserted subcutaneously by means of
surgical operation. Implants must
minor be
Packed individually in sterile conditions.
Contains rate controlling excipients. Mainly
employed to administer hormones. sterile.
⚫ Vaginal Tablets – uncoated bullet shaped or

ovoid tablets. They are designed to dissolve

slowly in the vaginal cavity. Used to release
medicaments to provide local pharmacological
effect and for systematic absorption.
 TABLETS TO PREPARE SOLUTIONS

Effervescent Dispensing
Tablets tablets

Hypodermic Tablet Triturates /

Tablets Moulded Tablets
⚫ Effervescent tablets – uncoated tablets
that contain the following – active
ingredient, organic acids (eg. tartaric acid),
and sodium bicarbonate. When dropped into
water, tablet reacts with water releasing
carbon dioxide, producing effervescence
leading to disintegration.
⚫ Dispensing Tablets – contain large amount

of highly potent active pharmaceutical

ingredients. They should be added to given
volume of water. Great care should be taken
in packaging and labelling. These tablets are
readily dispensed into liquids.
⚫ Hypodermic tablets – soft readily
soluble tablets. Tablets composed with
drugs that are water soluble and they are
dissolved in sterile water or water for
injection, and administered via
parenteral routes.
⚫ Tablet triturates– small cylindrical
molded or compressed tablets. They
usually contain a potent drug mixed with
excipients like lactose, sucrose or any
other suitable diluent. Prepared in
special molds
 Effervescent
Tablets

Hypodermic Tablets Mold for Tablet Triturates

 EXCIPIENTS
Pharmaceutical Excipients :- are substances
other than the pharmacologically active drug
or pro -drug which are included in the
manufacturing process or are contained in a
finished pharmaceutical dosage form.
⚫ Helps the drug to exert its action at the required

location.
⚫ Also it keeps the drug from being released early.

⚫ Some may help in protecting the product

stability, taste better, look better, improve
patients compliance and also to break into
smaller pieces.
CHELATING PRESERVATIVES DILUENTS
AGENTS
BINDERS
ANTI-
OXIDANTS
LUBRICANTS
BUFFERS
TYPES OF
EXCIPIENTS DISNTEGRANTS
DISSOLUTION
ENHANCERS
COLOURANTS

DISSOLUTION
RETARDANTS FLAVOURS &
SWEETNERS
ANTI-
ADSORBANTS ADHESIVES GLIDANTS
 DILUENTS
 Also known as fillers or bulking agents.
 Use for making up of required bulk for a tablet.
 Mostly used when dose of drug is too small to
formulate as a tablet. If the dose is high, bulking
agents are avoided.
 Properties of an ideal diluent :- physiologically
inert, non toxic, physically and chemically stable,
easily available, free from microbial contamination,
and does not affect the bioavailability of drug.
 Diluents can be of the following types:- lactose,
spray dried lactose, mannitol, dextrose, starch,
sorbitol, sucrose and microcrystalline cellulose.
⚫ Lactose – Most widely used Diluent. Available
in the hydrous and anydrous form. Preferred
because of pleasant taste, readily dissolvable in
water, low cost and less disintegration time. One
disadvantage is that it undergoes discolouration
when in contact with amine drugs
⚫ Spray dried lactose – can be used for direct

compression due to its cohesive nature and good

flow characteristics. In presence of moisture,
they may undergo darkening.
⚫ Mannitol – widely used as a diluent in
chewable tablet. It is non-hygroscopic and non-
carcinogenic. But mannitol is expensive.
⚫ Dextrose – Available in the hydrous and
anhydrous form. When combined in a certain
amount with spray dried lactose, darkening of
spray dried lactose can be avoided.
⚫ Starch – very occasionally used diluent for

tablet manufacturing. USP grade of starch

can be used due to its free flowing nature
and direct compressibility.
⚫ Sucrose – suitable for direct compression.

⚫ Microcrystalline cellulose – two main

grades are available but they are expensive,
so used in combination with other diluents.
 BINDERS
 One of the most important excipient in tablet
formulation.
 Also called as Adhesives.
 When mixed with powders, they are used to produce
granules.
 Enhance the free flowing capacity of granules of
desired sized and hardness.
 Selection of binder depends on the type of tablet.
 For eg. lozenges require more amount of binder
whereas tablets require less.
 Binders can be of the following types:- gum
acacia, tragacanth, starch paste, sucrose solution,
polyvinylpyrolidine, gelatin, celluose derivatives –
HPMC, HEC.
⚫ Gum acacia and tragacanth – used alone in a
concentration of 10-25% or in combination.
⚫ Gelatine – should be prepared fresh and added in

warm condition to avoid solidification.

⚫ Starch paste – is prepared by dispensing starch into

cold purified water, warming the mixture by

continuous stirring until a translucent paste is formed.
⚫ Sucrose solution – is used a wet binder which is

cheap, produces hard but brittle granules. Major

disadvantage is the susceptibility to microbial
contamination.
⚫ PVP – used in an aqueous or alcoholic solution.

Suitable for moisture sensitive drugs.

⚫ Cellulose derivatives – natural polymer as binder.
 LUBRICANTS
 Are intended to reduce the friction between the
walls of the tablet and walls of the die cavity during
the ejection of tablet. Concentration and time of
mixing of a lubricant should be optimised. If the
concentration is more, mechanical strength of the
tablet is reduced.
LUBRICANTS

SOLUBLE INSOLUBLE
LUBRICANTS LUBRICANTS
⚫ Insoluble Lubricants – act by inter-crossing the
intermediate layer between the tablet material and the
die cavity. Such lubricants are intended to act on the
tablet surface or on the tablet coating surface, so
added in the last stage before compression.
⚫ E.g – Calcium or Magnesium stearate, light mineral

oil, paraffins etc.

⚫ Optimum concentration – 1-4%

⚫ Soluble Lubricants – not effective as the insoluble

lubricant.
⚫ E.g – adipic acid, magnesium lauryl sulphate,

sodium lauryl sulphate, polyethylene glycol 4000,

6000, 8000.
 DISINTEGRANTS

 Intended to break up a tablet to smaller pieces

upon administration, when it comes in contact
with the gastro intestinal tract.
 Tablet disintegration is important for the further
dissolution of the drug and attaining the drug
bioavailability.
 Mainly used disintegrants – starch, cellulose and
cellulose derivatives. Starch is mainly used due to
its cheaper cost, ease of availability, and
compatibility with drugs.
 Optimum concentration – 5-
20%
MECHANISM OF DISINTEGRATION
⚫ Water uptake through pores
⚫ Acts by swelling of disintegrants
⚫ Acts by producing gas
⚫ Enzymatic action
Water uptake through pores
⚫ Water uptake through the pores due to
capillary action leads to disintegration.
⚫ Hence, hydrophobicity can be a
disadvantage for disintegrants using this
mechanism.
⚫ Maintenance of the porous structure of the
drug is also an important factor.
⚫ E.g – Starch and Microcrystalline
cellulose
Swelling of Disintegrants
⚫ One general problem of such disintegrants is its
thickness or forming of a gelatinous mass on
contact with water.
⚫ E.g – Acacia and Tragacanth
⚫ Optimised concentration should be used,
otherwise it may lead to sticking of the
powder.
Disintegrants that work due to the porous
structure and by swelling are called
Superdisintegrants
• E.g – sodium starch glycolate, sodium
glycine carbonate, insoluble cationic
exchange resins
Acts by producing gas
⚫ Used when extra rapid disintegration is
required.
⚫ Main disadvantage is its stability. When in
contact with the slight excess of moisture, it
can initiate the reaction.
⚫ Stringent control on the environment is
required for such type of disintegrants.
Enzymatic action
⚫ Enzymes are to act in the
included presence of water.
⚫ E. g – Amylase.
 FLAVOURS & SWEETENERS

 Flavours and sweeteners are added in the

formulation to mask the unpleasant taste. Added in
the concentration – 0.001 – 0.1 %
 Dissolved in organic solvents and then the solution
is sprayed on the granules just before the step of
compression.
 Natural sweeteners :- sugar, mannitol, lactose,
sucrose
 Artificial sweeteners :- saccharin, cyclamate,
aspartame
 COLOURANTS

 Added to the preparation to make the tablet more

aesthetic.
 Also used to identify the product.
 All colourants used should be approved and certified
by the Food and Drug Administration.
 Colours are available in two forms : - lakes and dyes
 E.g – Eosin Y, Sunset yellow FCF, Yellow orange,
Blue green, Burnt sugar.
 ANTI -
ADHESIVES

 Prevents sticking of the tablet material to

the face of the punch or on to the die cavity.
 All lubricants can be used as anti-adhesives
except for water soluble lubricants.
 E.g – Talc, Magnesium stearate, Colloidal
silica
 GLIDANTS
 Used to facilitate or promote flow of granules
from hopper to die cavity by reducing
friction between the particles
 E.g – Talc
 Optimum concentration – 4-5%

Lubricants, Together
Glidants called as
and Anti – Antifrictional
Adhesives Agents
 ADSORBANTS
 Usually agents that can retain large quantities of
liquid
 E.g. – anhydrous calcium phosphate, magnesium
carbonate, kaolin
BUFFERS
 Added to maintain a required pH.
 E.g – sodium bicarbonate, sodium citrate
ANTIOXIDANTS
 Added to protect drug from oxidation
 Anti-oxidants undergo oxidation instead of the
drug
 E.g – ascorbic acid, sodium bisulphite
 CHELATING AGENTS
 Tend to form complexes with trace amount of
heavy metal ions that can initiate oxidation by
theor catalytic activity
 E.g. – ethylenediamine tetraacetic acid {EDTA},
citric acid

PRESERVATIVES
 Prevents the growth of microorganism that
can
lead to contamination
 E.g – parabens like methyl paraben, propyl
paraben
 DISSOLUTION ENHANCERS

 Alter the molecular forces between the

ingredients to enhance the dissolution process
leading to faster therapeutic action
 E.g. – surfactants

DISSOLUTION RETARDANTS
 Incorporated into tablets that are intended for
controlled or delayed release.
 E.g – waxy materials like stearic acid and their
esters
 TABLETS GRANULATION

Tablet Granulation:- is the process in which

small powder particles adhere together by
forming bonds between them, resulting in the
formation of large aggregates called granules.
The bonds are formed either by compression
or by using binding agents.
 IMPORTANCE OF TABLET GRANULATION
Even though powders are present, granules are
prepared due to the following reasons :-
 To avoid particle separation in powders, due to their
different size, shape and densities.
 Enhance the flow property. Higher flow ability gives
better filling of dies or containers.
 Granules have higher porosity.
 Improves compressibility of powders.
 Materials that are hygroscopic may adhere and form
a cake if stored as a powder.
 Granulation of toxic materials will reduce the hazard
of generation of toxic dust, which may arise during
the handling of powders.
 GRANULATION METHODS

Granules are used in the manufacturing of

Tablets and Pellets.
GRANULATION METHODS

DIRECT DRY
COMPRESSION GRANULATION

WET
GRANULATION
 DIRECT COMPRESSION
Direct compression is a dry process where in the
powdered material is compressed directly into the tablets
without the physical nature of the powder being modified
Direct Compression involves the following steps:-
 Weigh and grind the ingredients (active ingredients
and excipients).
 Mixing of active ingredients with powdered excipients
including the lubricants and glidants.
 Compression of mixed powders in a tablet press.
 Diluent – spray dried lactose, mannitol
 Disintegrants – talc
 Lubricants – magnesium stearate
 Glidants – talc, colloidal silica
⚫ Advantages – fewer processing steps, less
equipment, less expensive, no involvement of
moisture and heat, faster dissolution rate, chance
of transfer losses, and lesser equipment
contamination.
⚫ Disadvantages – selection of excipients is

highly restricted due to less inherent binding

property in most of the excipients, low dose of
drugs will not be uniformly mixed, excipients for
direct compression are expensive and they also
have a problem of interaction with drug
substances.
 WET GRANULATION
Wet or Moist granulation is the most
conventional, versatile, and widely used techniques for
the manufacture of compressed tablets.
This technique involves the usage of liquid
to form compact masses.
Wet granulation involves the following steps:-
 Weigh, sift and mix of drug substance and excipients
excluding lubricants in an appropriate mixer to get
uniform powder mix.
 A damp mass is prepared from the powder mix using
binder
a solution. Insufficient binder causes poor
adhesion leading to soft tablets. Excessive binder
solution yields hard tablets with slower disintegration
rate.
 Wet granules are dried in an hot air oven at 60℃. The
drying temperature and drying time are carefully
observed.
 Dried granules are passed through Sieve 20 to get
uniform size granules.
 Appropriate amount of lubricants is mixed with
granules. The remaining amount of disintegrants are
also added at this stage.
 Mixed granules are compressed in a single or multi-
punch station tablet press fitted with appropriate
punches and dies.
⚫ Advantages – produce more spherical granules,
have better flow property, useful for low
compressibility drugs, ensures better content
uniformity in case of low dose drugs, improved
compressibility, suitable for hydrophilic drugs.
⚫ Disadvantages – several steps are involved,

time, labour, energy, equipment and space

required for the process is more, not suitable for
hydrophobic, thermolabile and moisture
sensitive materials, water used as solvent can
affect the drugs stability causing hydrolysis,
drying time is longer, increased length of process
.
 DRY GRANULATION

Dry or Double compression is used to form

granules without using a liquid solution because the
product to be granulated may be sensitive to moisture
and heat.
The techniques of dry granulation of powdered
material can be accomplished by two methods :-
1. Slugging – formation of extra large tablets first,
then broken into granules, which are
again recompressed.
2. Roller compaction method – achieved by feeding
powder through a set of directly opposed
counter rotating rollers.
Dry granulation involves the following steps:-
 Appropriate quantities of ingredients and excipients are
weighed on an analytical balance.
 Ingredients are mixed in a powder mixer until a uniform
powder mix is achieved. The half quantity of lubricant is
added at this stage to enhance powder flow and to prevent
sticking of powder to die.
 Mixed ingredients are compressed into flat large tablets
called slug. This is called pre-compression or slugging.
 Slugs are broken into smaller pieces using an appropriate
miller. Milled slugs are sieved to produce uniform granules.
 After sieving, remaining lubricants and excipients are
incorporated into granules and mixed to form a uniform
blend.
 Mixed uniform blend of granules are compressed into
tablet using the tablet press.
⚫ Advantages – requires less equipment and
minimum floor space, suitable for moisture and
heat sensitive materials, no alteration in drug
morphology during formulation, shows better
disintegration as dry binder has lesser adhesive
effect.
⚫ Disadvantages – process generates dust which

can cause cross contamination, separation of

components may occur after mixing, flowability
of powder decreases .
 TABLET COMPRESSION
MACHINES
Dried granules are compressed into tablet
using machines known as Tablet Compression
machines or Tablet Press.

TABLET COMPRESSION MACHINES

SINGLE PUNCH DRY COTA TABLET

TABLET MACHINE MACHINE

MULTI STATION
ROTARY PRESS
 Tablet presses are designed with following
basic components.
 Hopper – holds an feed granules to be
compressed.
 Dies - define size and shape of tablet
 Punches – compresses granules within the
dies.
 Cam Tracts – guides the movement
of punches
 Feeding Mechanism – moving mechanism
of the granules from the hopper to the dies.
HOPPER
PUNCHES & DIES

CAM
TRACT
 SINGLE PUNCH TABLET MACHINE

Also called as ECCENTRIC PRESS.

Ideal for Small Scale Productions. This
tablet press includes a Die and a pair of
Upper and Lower Punch, along with the
basic components. Also the machine has two
more components :-
 Capacity Regulator – adjusts lower
punch to allow the required quantity of
granules by the die.
 Ejection Regulator – facilitates ejection of
tablet from die cavity after compression.
 WORKING OF SINGLE PUNCH STATION
 The upper punch moves up and lower punch moves
down to create a cavity in the die.
 Feed or granules from the hopper fall into the dies.
 Upper punch moves down - compresses the
granules into tablets
 Upper punch moves up, lower punch also moves up
– eject the compressed tablet.
 Whole process repeats again and again, until
granules finishes.
 Output – 200 tablets per minute
 Uses high pressure to compress tablet to reduce
weight variation between tablets.
 MULTI STATION ROTARY PRESS
Multistation rotary presses are termed as
“rotary” because the head that holds the die, upper
and lower punches in place – Rotates.
As the head rotates, the punches are guided up
and down by fixed cam tracts.
The portion of the head that hold the upper
punches are called upper turrets, and the portion that
hold the lower punches are called lower turrets. The
portion holding the dies are called die table.
Along with the basic components, additional
components are,
 Ejection cam – facilitates ejection of tablet from die
 Take off blades – helps to push tablet to a discharge
chute, which is collected in a container.
WORKING OF MULTISTATION ROTARY
PRESS
 The powder or granules are placed in the hopper.
 Material is fed into several dies simultaneously.
 Machine removes excess of powder to avoid any
form of inconsistencies.
 Desired volume and weight of powder
is compressed to tablets.
 Upper and lower punch exert a predetermined
amount of pressure that compresses the tablet.
 As the head revolves, dies get filled with granules
flowing from the hopper.
 Granules are compressed when the upper and
lower punch comes close together.
 The upper cam pull the upper punches back to the
initial position and the lower punches are lifted up
to eject processed tablets out of the die cavity.
 Scraper will remove the tablet from compression
machine.
 This is then considered, as the end of one
compression cycle of the tablet compression
machine
 Output – 1200 tablets / minute.
 Used for large scale production.
 DRY COTA TABLET MACHINE

Here, two rotary machines work

simultaneously, therefore, core tablet is
prepared in one and
transferred machine, to then
compress coating. the machine
 Preferred foranother
multicompressed, for
multicoloured and press coated tablets
 Allow manufacture to manufacture a wide
variety of tablet shapes.
 EQUIPMENT TOOLING

Equipment tooling:- The size and the shape of

a tablet, and certain identification markings
are determined by the equipment tooling or
compression machine tooling.
⚫ Each tooling set consists of die and upper and

lower punches.
⚫ Tooling must meet the requirements to satisfy

the needs of dosage uniformity, product

efficiency and aesthetic appearance.
Basically, there are two types of equipment
tooling or compression machine tooling.

EQUIPMENT TOOLING

D TOOLING BB TOOLING
PARAMETERS D TOOLING BB TOOLING

Compression
force exerted by
the machine on 10 tonnes 6.5 tonnes
the tools

Barrel diameter
1 inch 0.75 inch
of the Punch

Head diameter of
1.25 inch 1 inch
the Punch

Length of the
5.25 inch 5.25 inch
Punch

Die Diameter 0.945 inch 1.18 inch

 Several types of steel are normally used for the
manufacture of compression machine tools. Steel
differs in toughness to withstand the compressing forces
and wear resistance. Therefore, selection of the steel
must be based on experience and accumulated history
of the product to be manufactured.
 Improper storage and handling can readily result
in damage and lead to the complete replacement of
the whole set of punches and dies.
 Punch tips are delicate and susceptible to damage,
if they come in contact with each other or with the
dies, or due to improper handling while insertion
and removal of the punches and dies.
 To avoid tooling damage, calculate the load or
pressure to be applied before the production starts.
 COMPRESSION &
PROCESSING PROBLEMS
An ideal tablet should be free from any
visual or functional defect. Number of problems
can be encountered during the tablet manufacture
process.
 Visual defects :- due to inadequate fines or
moisture in granules or faulty machine settings.
They can be further due to the following factors
:- formulation design, tabletting process, machine
related, or others.
 Functional defects :- due to a faulty
formulation calculation.
 CAPPING &
LAMINATION
PROCESS
RELATED CHIPPING &
CRACKING

PICKING & STICKING

VISUAL FORMULATION WEIGHT &

DEFECTS RELATED HARDNESS
VARIATION

MOTTLING

MACHINE DOUBLE
RELATED IMPRESSION
 1. CAPPING & LAMINATION
1. Capping – partial or complete separation of top or
bottom crown of the tablet from the main
body of the tablet
2. Lamination – separation of the tablet into 2 or
more distinct layers.
Capping & lamination occurs due to the following
reasons:-
 Presence of excess fine powders will lead to
entrapment of air in the tablet during
compression
. This air has a tendency to come out leading to
cappig and lamination. Quantity of fine
incorporated should be optimised to correct the
 Worn out punches and dies also cause capping and
lamination. Hence, replacement of the punches are
required. Chromium plated dies can be used to correct
the problem.
 High pressure also an be used, which can be
optimised before the production starts.
 Insufficient or improper lubricant can cause this
problem, hence the amount of lubricant used can be
optimised or the type of lubricant can be changed.
 Addition of oily or waxy materials can cause
capping and lamination, that can be corrected by the
usage of adsorbents or absorbents.
 Over drying of granules are also a major reason for
capping and lamination to occur. This can be overcome
by the addition of optimum level of moisture.
 2. PICKING
Picking – material gets off from the tablet
surface and adheres to the face of the
punch.
Reasons :-
 When punches have letters with sharp edges
like A, B, M, W etc.
 When granules are improperly dried.
 When materials have low melting point.
Corrections :-
 punches that have sharp edged letters can
be corrected by modifying the design of
letters.
 When using low melting point materials, punches
 3. STICKING
Sticking – material gets off from the
tablet surface and adheres to the
die wall.
Reasons :-
 Presence of excess moisture.
 Improper lubrication of granules.
 Fast compression process.

Corrections :-
 Proper drying of granules.
 The amount of lubricant used can
be optimised or the type of
lubricant can be changed.
 Speed of the compression process
should be optimised
 Dies should be polished with
colloidal silica
 4. MOTTLING
Mottling :- is a defect that occurs with
coloured tablets.
 Mottling occurs due to the uneven
distribution of the colour on the surface
of the coloured tablets.
Reasons :-
 Migration of the dye on the tablet
surface during the process of drying
 Decomposition of active ingredient or
excipients improper mixing of colour
binder solution
Corrections :-
 Change the solvent system and decrease
of temperature while drying.
 Incorporating dry colour excipients and
fine powdered adhesives during mixing
step of ingredients. Then the granulating
liquid is added to prepare granules.
 5. CHIPPING

Chipping :- is a defect where the film on

the edges of the tablet is chipped or
dented.
Reasons :-
 Dry granules
 Addition of large amount of binder
 Worn out edges of the punch

Corrections :-
 Addition of hygroscopic substances to
moisten the granules.
 Polishing of edges of punch.
 Optimisation of the amount of binder.
 6. CRACKING

Cracking :- is a defect where upper and

lower central surface of tablets gets
cracked.
Reasons :-
 Dry granules
 Size of granules are too large, air can
get entrapped between the cavities,
and during compression cracking
occurs.
 Deep concave shaped punches

Corrections :-
 Addition of right amount of binder
moistening the granules.
 Reduce granules size or add fines.
 7. DOUBLE IMPRESSION
Double impression – is a defect where the
shape of the monogram or other
engravings appears stamped twice on the
tablet.
Reasons :-
 Due to the free rotation of the lower punch. The
lower punch moves slightly upward before
the ejection of a tablet and makes new
impression on the bottom of the tablet
Corrections :-
 Control the free rotation of any punches
 8. WEIGHT VARIATION
Weight variation– occurs when tablets
compressed do not have uniform
weight .
Reasons :-
 When granules are not in uniform size.
This changes the filling of granules in
the die. Large size or too small size
granules changes can hence cause
weight variation.
 Poor flow of granules from the hopper
to the die. Rat holing, where the
powder gets deposited over the inner
walls of the hopper, this obstructs the
flow of powder from the hopper to die.
Corrections :-
 Addition of vibrator to the hopper to
improve the flow of powder.
 9. HARDNESS VARIATION
Hardness variation– occurs when tablets
compressed do not have uniform
hardness.
Reasons :-
 No uniform weight
 Incorrect space between the upper and
lower punch at the time of compression
Corrections :-
 Maintain the weight of the tablet.
 Optimum gap between the upper and lower punch
should be maintained.
LONG ESSAYS For 10 marks
1. Explain in detail manufacturing defects of tablets. With
reasons and remedies.
2. Explain manufacturing defects in uncoated tablets with
their reasons and remedies
3. Define tablet coating. Explain in detail the process of sugar
coating of tablets
4. Describe dry granulation techniques and list advantages
and disadvantages
5. Enlist various quality control tests of tablets and explain in
detail
6. Classify granulation techniques. Describe the wet
granulation method along with equipment used in each
step
Short ESSAYS For 05 marks
1. Write in detail wet granulation technique
2. Write the different granulation techniques. Explain dry
granulation
3. Define coating. Explain sugar coating of tablets. Write its
advantages and disadvantages
4. Importance of angle of repose and bulk density of drugs in
pre-formulation studies
5. Write the formulation of tablets
6. Explain different steps involved in sugar coating of tablets
7. What are various defects in tablets and how they may be
rectified?
8. Write a note on excipients used for enteric coating process
9. Explain the steps involved in sugar coating
Short answer For 02 marks
1. Differentiate between amorphous and crystalline
powder
2. Write the importance of angle of repose in
tableting
3. Define capping and lamination
4. Write the applications of pellets
5. Advantages of film coating of tablets
6. Give four examples of artificial sweeteners
7. Why granulation is an essential step in the tablet
preparation? Justify