USP <1216> Tablet Friability Testing Explained (+ Excel Calculator Template)
Friability refers to the tendency of a tablet to chip, crumble, or break during transportation. This can transpire when the tablet is being handled, packaged, or transported, potentially resulting in the administration of an incorrect dose to the patient. USP <1216> Tablet Friability shows the guidelines for determining the friability of compressed, uncoated tablets.
To test for friability, pre-weighed tablets must be placed in a tablet friability apparatus where the tablets are tumbled 100 times. After rotating, the tablets are weighed and the weight loss is calculated. If the results are difficult to interpret, it is recommended to repeat the test twice and get the mean of the three tests. A weight loss of 1.0% is considered acceptable for most products. If the tablets crack or break during the process, the samples fail the friability test.
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Tablet Friability Loss of Mass Calculator Preview
Frequently Asked Questions
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Tablet friability refers to the tendency of a tablet to chip, crumble, crack, or break during handling, packaging, transportation, and storage. It is an important quality attribute used to evaluate tablet durability.
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Tablet friability testing is described under:
USP <1216> Tablet Friability
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The purpose is to determine whether tablets can withstand mechanical stress without excessive chipping, abrasion, or breakage during manufacturing and distribution.
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The general procedure includes:
Weighing tablets before testing
Placing tablets in the friabilator
Rotating the drum for a specified number of revolutions
Reweighing tablets after testing
Calculating percentage weight loss
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For most tablet products, acceptable friability is:
% Friability≤1.0%
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