Chapter 7 Dissolution studies

Abstract

Publisher Summary Dissolution testing monitors the rate at which a solid or semisolid pharmaceutical dosage form releases the active ingredients into a liquid medium under standardized conditions of liquid/solid interface, temperature, and media composition. Dissolution tests are defined as category III by the U.S. Pharmacopeia (USP)—that is, “an analytical method for the determination of performance characteristics.” When dissolution is the rate-limiting factor in the absorption of a drug, a rank order correlation between dissolution rate and bioavailability can often confirm bioequivalency among product batches. Dissolution testing is primarily used in industry as a quality control tool to monitor the formulation and manufacturing process of a dosage form. Dissolution is considered by most regulatory agencies as a highly critical quality characteristic for most solid dosage forms. A complete dissolution validation package considers at a minimum the dissolution apparatus used, the calibration requirements, and any appropriate governmental or regulatory guidelines.