FDA: Guidance on Quality Chewables

October 8, 2018

The FDA released final guidance on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily.

Developers should focus on hardness, disintegration and dissolution in addition to factors that could influence the drug’s bioavailability and bioequivalence, the agency said. For example, chewables should be hard enough to withstand the manufacturing, packaging, shipping and distribution processes, but should also be easy to chew and disintegrate quickly enough so they don’t cause obstructions in patients who don’t chew them completely.

To make sure this is the case, in vitro disintegration tests should be conducted using established disintegration equipment and methods, the FDA says.

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