Biowaivers and comparative in-vitro dissolution


Dissolution form an essential part of pharmaceutical development of solid oral dosage forms and suspensions for comparison of the release properties of the pivotal batches to demonstrate in vitro similarity. The media and conditions chosen in the studies depend upon the required release characteristics of the intended product.

The selection of the dissolution specifications (conditions and acceptance criteria) for product release and stability study purposes is determined according to international guidelines such as: FDA, USP and Biopharmaceutics Classification System (BCS).