Evaluation Parameters of Tablets

TABLET EVALUATION:
• Introduction.
• General appearance.
(i) Size & shape.
(ii) Organoleptic properties.
• Weight variation
• Content uniformity.
• Mechanical strength of tablet.
(i) Hardness.
(ii) Friability
(iii) Tensile strength.
• Disintegration test.
• Dissolution test.
Why to evaluate tablets?
• To monitor the product quality.
• For quantitative evaluation & assessment of tablet properties.
• To check chemical breakdown.
• To check the interactions between physical components of tablets.
GENERAL APPEARANCE :
• Size & shape :
• Tablet thickness varies with changes in:-
(i) Die fill
(ii) Particle size distribution
(iii) Packing of the powder mix being compressed & with tablet
weight.
• The thickness of tablet is measured with a micrometer.
• Tablet thickness should be controlled within a ±5% variation of a
standard value.
GENERAL APPEARANCE :
• Organoleptic properties
• Color (no mottling)
• Odor (e.g. film coated tablets).
• Taste (e.g. chewable tablets).
WEIGHT VARIATION:
• Weight variation:- The USP has provided limits for the average weight
of uncoated compressed tablets.

Average weight (mg) Percent difference (%)

130 mg or less 10

>130 mg but <324 mg 7.5

324 mg or more 5
CONTENT UNIFORMITY:
• Every tablet contains the amount of drug substance intended with
little variation among tablets within a batch.
• The content uniformity test has been included in the monographs
(coated and uncoated tablets, capsules).
• For content uniformity test, representative samples of 30 tablets are
selected and 10 are assayed individually. Nine of the 10 tablets must
contain not less than 85% or more than 115% of the labeled drug
content.
CONTENT UNIFORMITY:
• The three factors that directly contribute to content uniformity
problems:
(i) non-uniform distribution of drug substance throughout the
powder mixture or granulation.
(ii) segregation of powder mixture or granulation during various
manufacturing processes.
(iii) tablet weight variation.
MECHANICAL STRENGTH OF TABLETS:
• It provides a measure of the bonding potential of the material
concerned and this information is useful in the selection of excipients.
• Excessively strong bonds prevents rapid disintegration & subsequent
dissolution.
• Can be quantified by:-
(i) Friability
(ii) Hardness
(iii) Tensile strength
FRIABILITY:
• The friability test is closely related to tablet hardness and is designed
to evaluate the ability of the tablet to withstand abrasion in
packaging, handling and shipping.
• Measured by the use of the Roche friabilator .
• Method:
• (i) A number of tablets (say 20) are weighed and placed in the
apparatus where they are exposed to rolling and repeated shocks as
they fall 6 inches in each turn within the apparatus.
• (ii) After four minutes of this treatment or 100 revolutions, the tablets
are weighed and the weight compared with the initial weight. The
loss due to abrasion is a measure of the tablet friability.
• (iii) The value is expressed as a percentage.
• (iv) A maximum weight loss of not more than 1% of the weight of the
tablets being tested during the friability test is considered generally
acceptable and any broken or smashed tablets are not picked up.
HARDNESS:
• Hardness or crushing strength determinations are made during tablet
production, are used to determine the need for pressure adjustment
on tablet machine.
• The force required to break the tablet is measured in kilograms and a
crushing strength of 4Kg is usually considered to be the minimum for
satisfactory tablets.
• The Monsanto or Stokes hardness tester.
• The Strong-Cobb apparatus.
• Schleuniger apparatus.
• Oral tablets have 4 to 10 kg hardness.
• Hypodermic and chewable tablets are usually much softer (3 kg).
• Some sustained release tablets are much harder (10-20 kg).
• Tablet hardness have been associated with other tablet properties
such as density and porosity.
Monsanto Hardness Tester
Strong Cobb Hardness Apparatus
TENSILE STRENGTH:
• This is the force required to break a tablet in a diametric compression
test.
• The radial tensile strength, T, of the tablets can be calculated from the
equation:
T=2F/πdH

• Where F is the load needed to break the tablet, d and H are the
diameter and thickness respectively.
• It is determined by static & dynamic methods.
DISINTEGRATION:
• For a drug to be absorbed from a solid dosage form after oral
administration, it must first be in solution, and the first important
step toward this condition is usually the break-up of the tablet; a
process known as disintegration.
• The disintegration test is a measure of the time required under a
given set of conditions for a group of tablets to disintegrate into
particles which will pass through a 10 mesh screen.
• The disintegration test is carried out using the disintegration tester
which consists of a basket rack holding 6 plastic tubes, open at the
top and bottom, the bottom of the tube is covered by a 10-mesh
screen.
• The basket is immersed in a bath of suitable liquid held at 37 O C,
preferably in a 1L beaker.
• For most uncoated tablets, the BP requires that the tablets
disintegrate in 15 minutes (although it varies for some uncoated
tablets) while for coated tablets, up to 2 hours may be required.
• To test for disintegration time, one tablet is placed in each test tube &
basket rack is positioned in a 1L beaker of water, simulated gastric
fluid at 37 o C ± 2 o C, such that tablets remain 2.5 cm below the
surface of liquid on their upward movement.
• A standard motor driven device is used to move the basket assembly,
at a frequency of 28-32 cycles/min.
• To be in USP standards, tablet must disintegrate & all particles must
pass through 10 mesh screen in specified time.
• Uncoated USP Tablets = 5 min (Aspirin tablets).
• Majority of tablets have a disintegration time of 30 min.
• Enteric coated tablets = 2 hours + time specified in monograph
(Simulated intestinal fluid).
DISSOLUTION:
• Dissolution is the process by which a solid solute enters a solution.
• Pharmaceutically, it may be defined as the amount of drug substance
that goes into solution per unit time under standardized conditions of
liquid/solid interface, temperature and solvent composition.
• Dissolution kinetics is important in determining the bioavailability of a
drug.
• Two objectives in the development of in-vitro dissolution tests are to
show:-
(i) that the release of the drug from the tablet is as close as
possible to 100%.
(ii) that the rate of drug release is uniform batch to batch. Thus we
can say that Rate of dissolution α efficacy of product. Rate of
dissolution α bioavailability.
• It is carried out in:-
(i) USP dissolution apparatus Type I (Basket type).
(ii) USP dissolution apparatus Type II (Paddle type).
• In general, a single tablet is placed in a small wire mesh basket
fastened to the bottom of the shaft connected to a variable speed
motor.
• The basket is immersed in the dissolution medium (as specified in the
monograph) contained in a flask. The flask is maintained at constant
temperature of 37 o C ± 5 o C by a constant temperature bath.
• The motor is adjusted to turn at the specified speed, and samples of
fluid are withdrawn at intervals to determine the amount of drug in
solution.
• For example: for methyldopa tablets the dissolution test calls for a
medium of 900 ml of 0.1 N HCl , apparatus 2 turning at 50 rpm, &
time limit of 20 min. The accepted amount dissolved in 20 min is not
less than 80% of the labeled amount of methyldopa.