Introduction

Ever since dissolution was known to have a significant effect on bioavailability and clinical performance, dissolution analysis of pharmaceutical solids has become one of the most important tests in drug product development and manufacturing, as well as in regulatory assessment of drug product quality. Not only can dissolution testing provide information regarding the rate and extent of drug absorption in the body, it can also assess the effects of drug substance biopharmaceutical properties and formulation principles on the release properties of a drug product. Nevertheless, despite the wide use of dissolution testing by the pharmaceutical industry and regulatory agencies, the fundamentals and utilities of dissolution testing are still not fully understood. The objective of this chapter is to provide a concise review of dissolution methods that are used for quality control (QC) and bioavailability assessment, highlight issues regarding their utilities and limitations, and review challenges of improving some of these current dissolution methods, particularly those used for assessing in vivo drug product performance. In this chapter, we first provide some background information on dissolution, including the significance of dissolution in drug absorption, theories of dissolution, and factors affecting dissolution testing. Second, we examine the current roles of dissolution testing. Third, we evaluate the utilities and limitations of dissolution as a QC tool under the current industry setting. Finally, we conclude this chapter by discussing the biopharmaceutics classification system (BCS) and biorelevant dissolution methods.

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