FDA sets dissolution, weight standards for orally disintegrating tablets

FDA has issued a final guidance that recommends limiting orally disintegrating tablets to a 30-second dissolution time and a weight of no more than 500 mg. FDA stated, however, that it was willing to be flexible on the weight requirement. If the ODT weighs more than 500 mg., sponsors must demonstrate that "its ability to perform effectively as an ODT should be justified based on product performance." The agency, however, refused to budge on the time limit requirement. Industry objected to the 30-second time limit when it was proposed in the 2007 draft guidance, recommending instead a 60-second limit, but to no avail. The guidance notes that "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." The guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet (ODT), which is a different dosage form than, for example, a chewable tablet or a tablet that should be swallowed whole with liquid