QUALITY CONTROL OF SOLID DOSAGE

FORM

A) TABLET:

The quality control of tablets includes following tests. These tests are-
1. Weight variation
2. Friability
3. Hardness
4. Disintegration test
5. Dissolution test
6. Leakage test for strips and blisters.

(1) Weight Variation:-

The volumetric fill of the die cavity determines the weight of the
compressed tablet. In setting up the tablet machine, the fill is adjusted to
give desired tablet weight. The weight of the tablet is the quantity of
granulation that contains the labeled amount of therapeutic ingredients.
After the tablet machine is in operation, the weights of the tablets are
checked routinely, either manually or electronically to ensure that proper
weight tablets are being made.
In general practice, composite samples of the tablets are (usually 10)
taken and weighed throughout the compression process. The composite
weight divided by 10, provides an average weight but contains usual
problems of averaged values. Within the composite sample that has an
acceptable average weight there could be tablets excessively overweight
or underweight. To solve this problem the USP/NF provides limits for the
permissible variations in the weights of the individual tablets expressed
as a percentage of the average weight of the sample.
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 METHOD OF TEST-
The weight of the individual 20 tablets are taken, calculate the average
weight and compare the individual tablets weight to the average. If no
more 2 tablets are outside the percentage limits then it is acceptable.
The weight variation tolerances for uncoated tablets differs depending
upon average tablet weight which is given below.
Average weight of the tablets (mg) Maximum % difference allowed
80 or less 10
80-250 7.5
More than 250 5

(2) Friability testing:-

The tablets may be subjected to a tumbling motion.e.g.during coating
packaging or transport may cause small particles to abrode from the
surface of the tablet. To examine this, friability test or test to measure
the resistance to abrasion is done. The laboratory friability tester is
known as the ‘Roche Friabilator’. This device subjects a no. of tablets
to the combined effects of abrasion and shock by utilizing a plastic
chamber that revolves at 25 rpm for 4 minutes dropping the tablets at a
distance of 6 inches with each revolution .The tablets are then dusted
and reweighed .Compressed tablets that lose less than 0.5-1% of their
weights are considered acceptable. Some chewable and effervescent
tablets undergo high friability weight losses. When concave and
especially deep concave punches are used in tableting, and when
punches are in poor condition or worn at their surface edges, tablets
produced results in ‘whiskering’ at the tablet edge. Such tablets have
higher than normal friability values because the whiskers are removed
in testing.
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 Tablet friability may also be influenced by the moisture content of the
tablet, granulation and finished tablets. A low but acceptable moisture
level acts as a binder. Very dry granulations that contains only
fractional percentages of moisture often produce more friable tablets
than granulations containing 2-4% moisture.
(3) Hardness testing:-
The resistance of the tablets to chipping, abrasion and breakage under
conditions of storage, transportation and handling before usage depends
upon its hardness. The monitoring of tablet hardness is especially
important for drug possess real or potential bioavailability problems or
that are sensitive to dissolution release profiles as a function of
compressive force.
Tablet hardness is defined as, ‘the force required to break a tablet in a
diametric compression test’.
To perform this test, a tablet is placed between two anvils, force is
applied to anvils, and crushing strength that just causes the tablet to
break is recorded. Hardness is also termed as tablet crushing strength.
There are various devices to test the hardness of the tablet.
1. Monsanto tester
2. Strong-cobb tester
3. Pfizer tester
4. Erweka tester.
5. Schleuniger tester

1. Monsanto Hardness Tester:-

It was developed approximately 50 years ago.

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The tester consists of a barrel containing a compressible spring held
between two plungers. The lower plunger is placed in contact with the
tablet, and a zero reading is taken. The upper plunger is then forced
against a spring by turning a threaded bolt until the tablet fractures. As
a spring is compressed, a pointer rides along a gauge in the barrel to
indicate the force. The force of fracture is recorded, and zero reading is
deducting from it.
2. Strong-cobb tester:-
It consist of a plunger activated by pumping a lever arm, which forces
an anvil against a stationary platform by hydraulic pressure. The force
required to fracture the tablet is read from a hydraulic gauge.
3. Pfizer tester-
It operates on the same mechanical principle as a pair of pliers. As the
pliers handles are squeezed, the tablet is compressed between a
holding anvil and a piston connected to a direct force reading gauge.
The dial indicator remains at the reading where the tablet breaks and is
returned to zero by depressing reset button.
4. Erweka tester-
The tablet is placed on the lower anvil, and the anvil is then adjusted
so that the tablet just touches the upper test anvil. A suspended weight,
motor driven, moves along a rail which slowly and uniformly transmits
the pressure to the tablet. A pointer moving along a scale provides the
breaking strength value in kilograms.

5. Schleuniger tester-

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 It operates in a horizontal position. An anvil driven by an electrical
motor presses a tablet at a constant load rate against a stationary anvil
until the tablet breaks. A pointer moving along a scale indicator
provides the breaking strength value. The instruments read in both
kilograms and strong-cobb units.
(4) Disintegration test:-

A tablet is generally formulated with a disintegration agent which will

cause the tablet to rupture and fall apart in water or gastric fluid. Factors
affecting the disintegration of the tablets are the physical and chemical
properties of the granulation, the hardness, the porosity and disintegrating
agent used. Disintegration does not imply complete solution of the tablet
or even its active constituent. Complete disintegration is defined as that
state in which any tablet residue remaining on the screen of a
disintegration apparatus is a soft mass having no palpably firm core. The
principle function of the test is to assure product uniformity.
Method of Test-
The USP/NF disintegration apparatus consist of a basket rack holding six
open end glass tubes, each 7.75 cm long having and having an inside
diameter and wall thickness of approximately 21.5 and 2.0 mm,
respectively. Attached to the underside of the lower plate holding the
tubes is 10 mesh stainless steel wire cloth. The basket rack is immersed
in a 1 L beaker containing an appropriate fluid at 37◦C.The basket rack is
raised and lowered through a distance of 5-6 cm at the rate of 28-32 cps.
The volume of fluid used is such that during the operation the basket rack
is never less than 2.5 cm below the surface of the fluid or above the
bottom of the beaker. Each tube is provided with a slotted and perforated

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cylindrical, transparent plastic disk which is placed on the top of the
tablet.
(5) Dissolution test:-
The test is intended to measure the time required for a given drug in an
oral solid dosage form to go into solution under a specific set of
conditions. It affords an objective means towards the evaluation of
physiological availability of the drug. Since drug absorption and
physiological availability is largely dependant upon having the drug in
the dissolved state, suitable dissolution rates are an important property of
a good tablet.
METHOD of TEST-
The USP/NF dissolution apparatus consists of a 1-L glass or other inert
transparent vessel with a slightly concave bottom, fitted with a variable
speed motor and a cylindrical stainless steel basket. The whole assembly
is immersed in a water bath at 37◦ C. The motor shaft is placed in the
center of the vessel to which the top part of the basket is attached. The
detachable part of the basket is made of welded seam; 40-mesh stainless
steel cloth formed into a cylinder 3.66 cm high and 2.55 cm in diameter.
The motor is regulated between 25 and 200 rpm and is maintained at the
rate specified in the individual monograph within 5%. The vessel is
immersed in the constant temperature bath and 900 ml of the dissolution
medium specified in the individual monograph is placed in it. When the
dissolution medium comes to a temperature of 37◦ C one tablet is placed
in the basket and is immersed to a distance of 2.0 cm between the basket
and concave bottom of the vessel. The basket is rotated and samples are
withdrawn for analysis.

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Apparatus 2, the stainless steel basket is replaced by a stirring blade 3-5
mm thick eccentrically mounted on a shaft 10.0 mm in diameter. The
blade is immersed to a distance of 2.5 cm between the blades lower edge
and spherical bottom of the vessel. The blade is rotated, and samples are
withdrawn for analysis at the rate and time specified in the monograph.

(6) Leakage test for strips and blisters:-

This test is very important to check the leakage of the strips and blisters
after packing of the tablets between them.
Requirements of test-Leak test apparatus capable of drawing desired
vacuum (not less than 375 mm Hg), sample holder and vacuum generator
desicater, 0.02 % w/v methylene blue solution, 0.5 mm wire and bean for
collection of tested strips.
Procedure- Prepare 0.02% w/v methylene blue solution (1200 mg of
methylene blue in 500 mg potable water) in a sample holder.

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B) CAPSULE:
The quality control of capsules includes following tests. These tests are-
1. Weight variation
2. Content Uniformity
3. Disintegration test
4. Dissolution test
5. Capsule Strength
6. Leakage test for strips and blisters.

REFERENCES

1. Leon Lachman, Herbert A. Lieberman, Joseph Kanig, The

theory and practice of industrial pharmacy, third edition ,

Varghese publishing house.
2. Leon Lachman, Herbert A. Lieberman, Joseph Kanig, Tablet

Vol.3, Varghese publishing house.

3. Remington, The science and practice of pharmacy, vol.1, 21st

edition, Lippincott Williams and Wilkins.

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