Friability test guidelines

Guidelines for friability test.

Friability testing is used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.
Friability is defined as the percentage of weight loss of powder from the surface of the tablets due to mechanical action and the test is performed to measure the weight loss during transportation .

It is a supplement test for Uncoated / Compressed Tablets other than physical measurement e.g. Hardness (Tablet Breaking Force).

Measuring the hardness of a tablet is not a reliable indicator for tablet strength as some formulations when compressed into very hard tablets tend to ‘cap’ or lose their crown portions on attrition. Such tablets tend to powder, chip and fragment.

In friability test the tablets are prone to abrasion hence enabling us to check for the tablet strength under application of force in different manner.
Generally, the test is run once. In case cracked, cleaved, or broken tablets are present in the tablet sample after conducting the friability test (tumbling of tablets) the sample fails the test.

In case the results are difficult to interpret or the weight loss is greater than the targeted value (NMT 1.0 %), the test is repeated twice and the mean of the 3 tests determined. A maximum loss of mass (obtained from a single test or from the mean of 3 tests) NMT 1.0 % is considered acceptable for most products.

This test can be performed according to the procedure prescribed in the pharmacopoeia such as USP, BP, IP etc

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Please review attached file for friability guideline International pharmacopoeia ninth edition,2019.pdf (114.1 KB)