TABLETS

INTRODUCTION

Tablet is defined as a compressed solid dosage

form containing medicaments with or
without excipients. According to the Indian
Pharmacopoeia Pharmaceutical tablets are
solid, flat or biconvex dishes, unit dosage
form, prepared by compressing a drug or a
mixture of drugs, with or without diluents
Classes of Commercial Tablets
1. Compressed – usually in large scale
production method
Classes :
a. multiple
b. single

2. Molded or Tablet triturates – commonly used

in small scale production
 Different types of Tablets

(A) Tablets ingested orally:

1. Compressed tablet, e.g. Paracetamol tablet
2. Multiple compressed tablet
3. Repeat action tablet
4. Delayed release tablet, e.g. Enteric coated Bisacodyl
tablet
5. Sugar coated tablet, e.g. Multivitamin tablet
6. Film coated tablet, e.g. Metronidazole tablet
7. Chewable tablet, e.g. Antacid tablet
(B) Tablets used in oral cavity:
1. Buccal tablet, e.g. Vitamin-c tablet
2. Sublingual tablet, e.g. Vicks Menthol tablet
3. Troches or lozenges eg. dequadin, strepsils
4. Dental cone
(c) Tablets administered by other route:

1. Implantation tablet

2. Vaginal tablet, e.g. Clotrimazole tablet

(D) Tablets used to prepare solution:

1. Effervescent tablet, e.g. Dispirin tablet (Aspirin)

2. Dispensing tablet, e.g. Enzyme tablet (Digiplex)

3. Hypodermic tablet

4. Tablet triturates e.g. Enzyme tablet (Digiplex)

 Tablet Ingredients
In addition to active ingredients, tablet contains a number of inert
materials known as additives or excipients. Different excipients are:

1. Diluent

2. Binder and adhesive

3. Disintegrents

4. Lubricants and glidants

5. Colouring agents

6. Flavoring agents

7. Sweetening agents
Tableting methods
 Compression

Tableting procedure
 Filling
 Compression
 Ejection
Tablet compression machines
• Hopper for holding and feeding granulation to be compressed
• Dies that define the size and shape of the tablet
• Punches for compressing the granulation within the dies
• Cam tracks for guiding the movement of the punches
• Feeding mechanisms for moving granulation from the hopper
into the dies
• Single punch machine
• Multi-station rotary presses
• The head of the tablet machine holds the upper
punches, dies and lower punches in place rotates
• As the head rotates, the punches are guided up and
down by fixed cam tracks, which control the
sequence of filling, compression and ejection.
• The portions of the head that hold the upper and
lower punches are called the upper and lower turrets
• The portion holding the dies is called the die table
 Compression cycle
• Granules from hopper empty in the feed frame (A)
containing several interconnected compartments.
• These compartments spread the granulation over a wide
area to provide time for the dies (B) to fill.
• The pull down cam (C) guides the lower punches to the
bottom, allowing the dies to overfill
• The punches then pass over a weight-control cam (E),
which reduces the fill in the dies to the desired amount
• A swipe off blade (D) at the end of the feed frame removes
the excess granulation and directs it around the turret and
back into the front of the feed frame
• The lower punches travel over the lower compression roll
(F) while simultaneously the upper punches ride beneath
the upper compression roll (G)
• The upper punches enter a fixed distance into the dies,
while the lower punches are raised to squeeze and compact
the granulation within the dies
• After the moment of compression, the upper punches are
withdrawn as they follow the upper punch raising cam (H)
• The lower punches ride up the cam (I) which brings the
tablets flush with or slightly above the surface of the dies
• The tablets strike a sweep off blade affixed to the front of
the feed frame (A) and slide down a chute into a receptacle
• At the same time, the lower punches re-enter the pull
down cam (C) and the cycle is repeated
• The principle modification from earlier equipment has
been an increase in production rate which is regulated by
– Number of tooling sets
– Number of compression stations
– Rotational speed of the press

Multirotary
High speed machine
rotary machine
Various instrument used in QC department: 

Disintegration apparatus
 Dissolution apparatus
 Analytical balance
 Muffle furnace
 Friability testing apparatus
 Bulk density apparatus
 Tablet hardness tester
 Infra red moisture content measuring apparatus
 U.V Spectroscopy
 Abbe Refractometer
 T.L.C. kit
 Karl fisher Titrimeter

Krupanidhi College of Pharmacy (Q.A)

UNITED STATES PHARMACOPOEIA
Physical tests applicable to tablet formulation:
-Bulk density / Tapped density of powder
-Powder fineness
-Loss on drying
-Disintegration test
-Tablet friability
-Dissolution test
-Drug release testing
-Uniformity of dosage form
-Container permeation test
-Labeling of inactive ingredients
Krupanidhi College of Pharmacy (Q.A)
 Evaluation of Tablet
Official and unofficial tests for evaluation
of tablets
 Official Tests:
1. Weight variation
2. Disintegration
3. Dissolution
4. Drug content
 Non-Official Tests:
1. Hardness
2. Friability
1. General Appearance:
The general appearance of a tablet, its identity and general
elegance is essential for consumer acceptance, for control of lot-
to-lot uniformity and tablet-to-tablet uniformity. The control of
general appearance involves the measurement of size, shape,
color, presence or absence of odor, taste etc.

2. Size & Shape:

It can be dimensionally described & controlled. The thickness
of a tablet is only variables. Tablet thickness can be measured by
micrometer or by other device. Tablet thickness should be
controlled within a ± 5 % variation of standard value.
3. Unique identification marking:
These marking utilize some form of embossing, engraving or
printing. These markings include company name or symbol,
product code, product name etc.
4. Organoleptic properties:
Color distribution must be uniform with no mottling. For
visual color comparison compare the color of sample against
standard color.

5. Hardness :
Tablet requires a certain amount of strength or hardness and
resistance to friability to withstand mechanical shocks of
handling in manufacture, packaging and shipping. Hardness
generally measures the tablet crushing strength.
Hardness (crushing strength):

It is the load required to crush the tablet when placed on its edge.

Why do we measure hardness?

 To determine the need for pressure adjustments on the tableting machine.

 Hardness can affect the disintegration.
 So if the tablet is too hard, it may not disintegrate in the required period of
time. And if the tablet is too soft, it will not withstand the handling during
subsequent processing such as coating or packaging.
 In general, if the tablet hardness is too high, we first check its disintegration
before rejecting the batch.
 If the disintegration is within limit, we accept the batch.
 If Hardness is high + disintegration is within a time accept the batch.
Factors Affecting the Hardness:

• Compression of the tablet and compressive force.

• Amount of binder. (More binder à more
hardness)
• Method of granulation in preparing the tablet
(wet method gives more hardness than direct
method, Slugging method gives the best hardness).
Limits: 5 kilograms minimum and 8 kilograms
maximum.
Make hardness test on 5 tablets and then take
the average hardness.
 DIFFERENT HARDNESS
TESTER

Monsanto Pfizer

Strong-cobb

Erweka Schleuniger
6.Friability:
Friability of a tablet can determine in laboratory by Roche
friabilator. This consist of a plastic chamber that revolves at 25
rpm, dropping the tablets through a Distance of six inches in the
friabilator, which is then operate for 100 revolutions. The tablets
are reweighed. Compress tablet that lose less than 0.5 to 1.0 % of
the Tablet weigh are consider acceptable.
It is the tendency of tablets to powder, chip, or fragment
and this can affect the elegance appearance, consumer
acceptance of the tablet, and also add to tablet’s weight
variation or content uniformity problems.
Friability is a property that is related to the hardness of
the tablet.
An instrument called Roche friabilator is used to
evaluate the ability of the tablet to withstand abrasion in
packaging, handling, and shipping test.
Procedure:
1. Weigh 20 tablets together = W1
2. Put these tablets in the friabilator and adjust the instrument at
100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W2

Friability (% loss) = W1 - W2/100

It must be less than or equal to1 % but if more we do not reject
the tablets as this test is non-official.
Perform this test using 20 tablets that were used first in the weight
variation
 7. Thickness test

• Thickness is an unofficial test .

• Thickness of the tablet is inversely proportional to hardness i.e.
increase in hardness decrease the thickness & vice versa.
• Thickness of tablet is measured by Vernier caliper/screw gauge.
• It is determined for 10tablets.

Vernier
caliper
 8.Weight variation test (uniformity of weight)

Weigh 20 tablet selected at random, each one individually . X1,

X2, X3… Xz
• Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20
Limit:
• Upper limit = average weight + (average weight * % error)
• Lower limit = average weight - (average weight * % error)
• The individual weights are compared with the upper and lower
limits.
• Not more than two of the tablets differ from the average weight
by more than the % error listed, and no tablet differs by more
than double that percentage.
WEIGHT VARIATION TOLERANCES FOR UNCOATED TABLETS

USP XX-NF STANDARDS

Sr. Average wt. of Max. %

No tablet(mg) difference
allowed
1 130 or Less 10%
2 130-324 7.5%
3 More than 324 5%

IP STANDARDS

Sr. Average wt. of Max. %

No tablet(mg) difference
allowed
1 84 or Less 10%
2 84- 250 7.5%
3 More than 250 5%
9. Content Uniformity Test:
It is an official test.
Randomly select 30 tablets. 10 of these assayed individually.
The Tablet pass the test if 9 of the 10 tablets must contain not
less than 85% and not more than 115% of the labeled drug
content and the 10th tablet may not contain less than 75% and
more than125 % of the labeled content. If these conditions are
not met, remaining 20 tablet assayed individually and none may
fall out side of the 85 to 115 % range.
10. Disintegration test (U.S.P.) :
Disintegration test is an official test.
It is the time required for the tablet to break into particles, the
disintegration test is a measure only of the time required under
a given set of conditions for a group of tablets to disintegrate
into particles
It is performed to identify the disintegration of tablet in
particular time period.
Disintegration test is not performed for controlled &
sustained release tablets.
The U.S.P. device to test disintegration uses 6 glass tubes
that are 3” long; open at the top and 10 mesh screen at
the bottom end. To test for disintegration time, one tablet
is placed in each tube and the basket rack is positioned in
a 1-L beaker of water, simulated gastric fluid or simulated
intestinal fluid at 37 ± 20 C such that the tablet remain 2.5
cm below the surface of liquid on their upward movement
and not closer than 2.5 cm cm at a frequency of 28 to 32
cycles per minute. Floating of the tablets can be
prevented by placing perforated plastic discs on each
tablet from the bottom of the beaker in their downward
movement. Move the basket containing the tablets up
and down through a distance of 5-6
According to the test the tablet must disintegrate and all particles
must pass through the 10 mesh screen in the time specified. If any
residue remains, it must have a soft mass.
Liquids used in disintegration
Water,
Simulated gastric fluid (pH = 1.2 HCl),
or Simulated intestinal fluid (pH = 7.5, KH2PO4 (phosphate buffer)
+ pancreatic enzyme + NaOH)

Disintegration test apparatus

 DISINTEGRATION TESTING CONDITIONS AND INTERPRETATION
Sr no. Type of tablets Medium Temperature limit
1 Compressed uncoated 37 ± 2 0C 15 minutes or as per
individual monograph
2 Sugar coated Water 37 ± 2 0C 60 minutes or as per
If 1 or 2 tablets fail 0.1 N HCL individual monograph
3 Film coated water 37 ± 2 0C 30 minutes or as per
individual monograph
4 Enteric coated 0.1 N HCL 37 ± 2 0C 1 hr or as per individual
& monograph
Phosphate
buffer pH
6.8
5 Dispersible/ water 37 ± 2 0C LST < 3 minutes or as
Effervescent per individual
monograph
6 Buccal 37 ± 2 0C 4 hr or as per individual
monograph
U.S.P. method for uncoated tablets:
Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate
completely within 30min repeat the same test on
another 12 tablet. (i.e. the whole test will consume 18
tablets).
Not less then 16 tablets disintegrate completely within
the time if more then two tablets (from the 18) fail to
disintegrate, the batch must be rejected.
For Coated tablets:
1. To remove or dissolve the coat, immerse the tablet in
distilled water for 5min.
Put the tablet in the apparatus in water or HCL for 30 min at
37oC (according to the U.S.P). If not disintegrated, put in
intestinal fluid.
If one or two tablets fail to disintegrate, repeat on 12
tablets. So 16 tablets from the 18 must completely
disintegrate within the time, if two or more not
disintegrated the batch is rejected.
U.S.P. and B.P Method for Enteric coated tablets:
1. Put in distilled water for five minutes to dissolve the coat.
2. Then put in simulated gastric fluid (0.1M HCL) for one hour.
3. Then put in simulated intestinal fluid for two hours.
If one or two tablets fail to disintegrate, repeat this test on
another 12 tablets. So 16 tablets from 18 should completely
disintegrate. If more than two fail to disintegrate the Batch
must be rejected.
11. Dissolution Test

Dissolution is an official test

Dissolution is performed to check the percentage
release from the dosage forms.i.e.tablet.
Tablet breaks down into small particles which offers
a greater surface area to the dissolving media.
Disintegration test does not give assurance that
particles will release drug in solution at an
appropriate rate, that’s why dissolution tests & it’s
specifications developed for all tablet products.
1. USP Dissolution apparatus I ( Basket method)
A single tablet is placed in a small wire mesh basket attached
to the bottom of the shaft connected to a variable speed
motor. The basket is immersed in a dissolution medium (as
specified in monograph) contained in a 1000 ml flask. The
flask is cylindrical with a hemispherical bottom. The flask is
maintained at 37 ± 0.50C by a constant temperature bath. The
motor is adjusted to turn at the specified speed and sample
of the fluid are withdrawn at intervals to determine the
amount of drug in solutions.
2. USP Dissolution apparatus II
( Paddle method)
It is same as apparatus-1, except
the basket is replaced by a paddle.
The dosage form is allowed to sink
to the bottom of the flask before
stirring. For dissolution test U.S.P.
specifies the dissolution test
medium and volume, type of
apparatus to be used, rpm of the
shaft, time limit of the test and
assay procedure for. The test
tolerance is expressed as a % of
the labeled amount of drug
dissolved in the time limit.