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or are dosed with liquids may be more appropriately considered to be chewable or oral tablets," FDA says in a draft guidance on orally disintegrating tablets scheduled for publication in the Federal Register April 9.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...