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FDA guidance on disintegrating tablets

This article was originally published in The Tan Sheet

Executive Summary

"Tablets that take longer than 30 seconds to disintegrate or are dosed with liquids may be more appropriately considered to be chewable or oral tablets," FDA says in a draft guidance on orally disintegrating tablets scheduled for publication in the Federal Register April 9. Additional parameters for consideration include tablet size, weight and component solubility, the agency adds. Because performance characteristics distinguish these products as separate dosage forms, matching the characteristics is an important requirement for ODT labeling, FDA notes. A wide variation in product characteristics in the first disintegrating tablets to reach the market prompted the agency to develop guidance for the category. Excedrin QuickTabs and Claritin Redi-Tabs are among the offerings in the OTC market...

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Oral disintegration guidance

FDA defines orally disintegrating tablets as generally taking 30 seconds to dissolve without chewing or liquids. In the Dec. 16 Federal Register, the Center for Drug Evaluation and Research defines oral disintegration for new and generic drugs in a 1guidance that outlines how to receive ODT designations for proposed drug products. The ODT definition FDA adopted in 1998 - a solid dosage form that disintegrates "usually within a matter of seconds" on the tongue - remains in effect, according to the guidance. Additionally, the 30-second limit, based on the U.S. Pharmacopeia or similar test methods, will apply, CDER says. Manufacturers should consider tablet size, weight, solubility of a product's components and how those factors affect the intended use when developing an ODT, says the guidance following a draft published in April 2007 (2"The Tan Sheet" April 9, 2007, In Brief)

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