QUALITY CONTROL TESTS FOR TABLETS AND CAPSULES

Presented by: A S K SANKAR

Quality Control of Tablets

General Appearance: -Size, shape, and thickness: This is important to facilitate packaging and to decide which tablet compressing machine to use. -Organoleptic properties: which include color and odor of the tablets.

Official Standards as per B.P. /I.P./ U.S.P.

COMPARISON OF DIFFERENT PHARMACOPOEIAL QUALITY CONTROL TESTS BRITISH PHARMACOPOEIA FOR ALL TABLETS: Content of active ingredients Disintegration Uniformity of content Labeling

Uncoated tablet: -Disintegration test -Uniformity of weight

Effervescent tablet: -Disintegration test -Uniformity of weight Coated tablet: -Disintegration test -Uniformity of weight

Gastro resistant tablet: -Disintegration test

Modified release tablet: -Uniformity of weight.

Dispersible tablet: -Disintegration test -Uniformity of dispersion -Uniformity of weight

INDIAN PHARMACOPOEIA Uncoated tablet: -Uniformity of container content -Content of active ingredient -Uniformity of weight -Uniformity of content -Disintegration test Enteric coated tablet: -Disintegration test

Dispersible tablet: -Uniformity of dispersion -Disintegration Soluble tablet: -Disintegration test Effervescent tablet: -Disintegration/ Dissolution / Dispersion test

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

Official and unofficial tests: Official Tests: Weight variation, disintegration, dissolution, drug content. Non-Official Tests: Hardness, friability.

I- Non official tests: 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 patch. And if the disintegration is within limit, we accept the patch. >If H. is high + disintegration is within time accept the batch.

Factors Affecting the Hardness: Compression of the tablet and compressive force. Amount of binder. (More binder 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. Friability: 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 tablets weight variation or content uniformity problems.

Friability is a property that is related to the hardness of the tablet. An instrument called friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping.

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 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 test

II- Official Tests: Disintegration: 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.

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)

Limits: For Uncoated tablets:

Temper Time ature limit According to Simulated 37oC Not U.S.P. gastric exceed fluid 30min According to water 37oC Not B.P. exceed 15min Medium

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 30min 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. 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 patch must be rejected.

B.P. method for Enteric coated tablets: 1. Put in distilled water for five minutes to dissolve the coat. 2. Put in simulated gastric fluid for two hours (emptying time). 3. Put in phosphate buffer (PH 6.8) for one hour. 4. If one or two tablets fail to disintegrate repeat on 12 tablets. So 16 tablets should disintegrate. If more than two tables fail to disintegrate reject the batch.

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%

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.

Quality control tests of capsules

B.P. method for disintegration of capsules:

Introduce one capsule into each tube and suspend the apparatus in a beaker containing 600 ml water @ 37oC. If hard capsules float on the surface of the water, the discs may be added. Operate the apparatus for 30 minutes; remove the assembly from the liquid.

>The capsules pass the test if No residue remains on the screen of the apparatus or, If a residue remains, it consists of fragments of shell or,

Uniformity of Weight of capsules: It is to be done on 20 capsules. Limit: Not more than two of the individual weights deviate from the average weight by more than the percentage deviation shown in the table, and none deviates by more than twice that percentage.

Average Weight of Capsule Less than 300 mg

Percentage Deviation

10

300 mg or more

7.5