Recent FDA Guidance On ODTs

Orally Disintegrating Tablets: The Effect of Recent FDA Guidance on ODT Technologies and Applications

Authors: Rosie McLaughlin, Susan Banbury, and Kieran Crowley

Ever since Zydis® lyophilization technology became the first approved ODT in the U.S. in 1996, the emergence of multiple ODT technology platforms have created regulatory challenges due to increasing variance in the critical-product attributes of ODTs, notably disintegration time and tablet size. The authors, Catalent technical directors and managers, discuss the various responsive technologies available to the manufacturer as well as the recent implications of the U.S. Food and Drug Administration’s Guidance for Industry: Orally Disintegrating Tablets.