Developing discriminatory drug dissolution tests and profiles: Some thoughts for consideration on the concept and its interpretation

Abstract

Drug dissolution profiles are increasingly used to evaluate drug release characteristics of pharmaceutical products. Discriminatory dissolution profiles are highly desirable for differentiating between products having differences in pharmaceutical attributes (formulation and/or manufacturing processes differences) that may reflect corresponding differences in vivo. Commonly in the literature,differences in the profiles based only on pharmaceutical attributes have also been described as discriminatory.This appears to have created confusion in properly defining and developing discriminating profiles.This article should help to clarify definition/concept,independent of the apparatus or procedure used,so that proper discriminating profiles may be developed for improved evaluation of pharmaceutical products.