Biorelevant Dissolution: Methodology and Application in Drug Development

Abstract

INTRODUCTION Dissolution testing can play an important role in several areas for drug products as a quality control tool to monitor batch-to-batch consistency of drug release from a dosage form and as an in vitro surrogate for in vivo performance that can guide formulation development and ascertain the need for bioequivalence tests. The possibility of substituting dissolution tests for clinical studies has been revealed by the development of the Biopharmaceutics Classification System, and dissolution tests that can predict the in vivo performance of drug products (usually called “biorelevant” dissolution tests) could serve this purpose (1, 2). In terms of media and hydrodynamics, biorelevant dissolution testing should provide a baseline for drug and dosage-form performance and should be used to guide formulation development, to identify food effects on the dissolution and bioavailability of orally administered drugs, and to identify solubility limitations and stability issues. The importance of the development of predictive dissolution testing is increased by the fact that the majority of drugs currently in development are poorly soluble drugs and by the challenges for new dosage-form approaches.