A REVIEW ON DEVELOPMENT OF BIORELEVANT DISSOLUTION MEDIUM

摘要

Dissolution testing is a valuable tool that provides key information about bioavailability or bioequivalency as well as batch to batch consistency of drug. Since the number of poorly soluble drug is increasing, the selection of adequate dissolution test for these becomes more and more important. Biorelevant is a term, used to describe a medium that has same relevance to the in vivo dissolution condition for the compound. The development of biorelevant dissolution medium includes simulation of gastrointestinal condition, hydrodynamic characteristics, and physicochemical parameters of drug, prediction of plasma profile and lastly the development of IVIVC. Biorelevant dissolution testing designed with appropriate simulated media and hydrodynamics are useful from the early stages of drug discovery and development for identifying the biopharmaceutical performance of compound (i.e. solubility problems, food effects, precipitation in the small intestine) through the later stages of development to assist in formulation strategies and the establishment of IVIVC that will lead to reduction of the number of animal experimentation, bioavailability and bioequivalence studies. The aim of this review article is to provide comprehensive information on the steps that should be considered during developing biorelevant dissolution medium for poorly soluble drugs and the composition of biorelevant dissolution medium to predict in vivo performance more accurately than the compendia dissolution medium.