MacroFLUX Generics

Purpose For generic formulation development, traditional (USP) dissolution tests provide primary input parameters for predicting in vivo performance of different drug formulations before conducting bioequivalence studies. Although USP dissolution tests are relatively simple to conduct for testing formulations, the in vivo predictive power of these tests is questionable1. Namely, when a poorly water-soluble API is formulated to enhance its dissolution, additives, such as surfactants, polymers and cyclodextrins have an effect not only on dissolution profile, but also on flux through the membrane.