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Oral disintegration guidance

This article was originally published in The Tan Sheet

Executive Summary

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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