A client approached FreeThink to determine which, if any, of their five tablet formulation options should be advanced to development. The client knew that stability would be challenging, and they had little time to complete the study.
FreeThink conducted a two-week simultaneous ASAPprime ® study on all five of the formulations, using the major degradant as the shelf-life limiting attribute.
Only Tablet Formulation 2 was sufficiently stable to warrant full development. Unfortunately, this formulation was not granulated, as needed for processing. Its higher activation energy suggested less acid/base catalysis. Slurry pH measurements confirmed this. With pH change in the wet granulation, greater stability should be achieved.