Guidance for Orally Disintegrating Tablets Issued

Rockville, MD (Dec. 18)-A US Food and Drug Administration guidance issued Tuesday, Dec. 16, 2008, provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs). The industry guidance, Orally Disintegrating Tablets, applies to manufacturers of new and generic products and is based on the April 2007 draft guidance of the same name.

According to the guidance, disintegration times of ODTs can range from a few seconds to more than a minute, but most have in vitro disintegration times of approximately 30 seconds or less. FDA is therefore recommending that, “ODTs be considered solid oral preparations that disintegrate rapidly in the oral cavity, with an in vitro disintegration time of approximately 30 seconds or less.”

The guidance goes on to say that tablets that take longer than 30 seconds to disintegrate or are dosed with liquids should be more appropriately labeled “chewable or oral tablets.” Another parameter in the guidance states that the weight of the ODT should not exceed 500 mg.