TABLETS TESTS

TABLETS TESTS

QUALITY CONTROL TESTS FOR TABLETS AND CAPSULES:

Official and unofficial tests:

Official Tests:

      Weight variation, disintegration, dissolution, drug content.

Non-Official Tests:

      @@@@ Hardness, @@@@friability.

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.

Friability:

 Procedure:

1. Weigh 20 tab altogether = 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

4. Friability (% loss) =It must be less than or equal to @@1% 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 test.

Liquids used in disintegration Water, simulated gastric fluid (PH = 1.2 HCl), or Simulated intestinal fluid (PH = 7.5, KH2PO4 (phosphate buffer) + pencreatin enzyme +NaOH).

Weight Variation (uniformity of weight) of tablets:

1.Weigh 20 tablet selected at random, each one individually . X1, X2, X3… Xz

2.Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20

Limits according to U.S.P

Weight of tablet 130 mg or less then %error =@@ ±10%

Weight of tablet 130-324 mg then %error =@@ ±7.5%

Weight of tablet 324 mg or more then %error = @@±5%