Dissolution Media for the Analgesic COX II Selective and Biopharmaceutical Classification II Drug- Nimesulide

Nimesulide (ND) is a Class II drug with dissolution rate-limiting absorption characteristics. ND is currently available in many European countries as well as India and Egypt. However, it is yet to be official in United States and British pharmacopeias. So there is scarce information on relevant in vitro dissolution media to predict its in vivo performance. There is a growing body of research to enhance and improve dissolution characteristics and many physiological and non-physiological simulating dissolution media have been utilized to evaluate its in vitro dissolution rates for ND from various developed formulations. Few of them successfully met sink conditions and showed good in vitro/in vivo correlation whereas the others were non-discriminatory to the developed formulations because of not fulfilling sink conditions. This review presented critical appraisal for major dissolution media used for ND in the literature as well as a case study for a developed dissolution medium simulating gastric fluid and the in vitro in vivo correlation.