FDAnews
www.fdanews.com/articles/114185-guidance-on-oral-disintegrating-tablets-is-made-final

Guidance on Oral Disintegrating Tablets Is Made Final

January 30, 2009
Orally disintegrating tablets (ODT) should have an in vitro disintegration time of roughly 30 seconds or less regardless of the manufacturing process used, according to an FDA guidance.

The final guidance on ODTs preserves the draft’s reasoning that ODTs are solid oral preparations that disintegrate rapidly in the mouth. The FDA does not accept labeling of a tablet as an ODT because it eventually disintegrates in the mouth, the guidance says.

“Although the value of 30 seconds is given as a desired result, it is not intended to represent an arbitrary distinction between an ODT and some other tablet form,” the FDA says in the guidance. “It is instead representative of a general time period associated with drug products that have been found to have performance characteristics appropriate for a disintegrating tablet meant to be taken without chewing or liquids.”
Drug GMP Report