A BRIEF REVIEW ON PHARMACEUTICAL DISSOLUTION INTERLINKING THE ASPECTS OF SCIENCE AND REGULATION

Abstract

Dissolution is a multistep process describes the affinity of the solute and the solvent by which a solid substance interacts among the heterogeneous phases of solute -solute, solvent-solvent, and the solute-solvent interface to yield a solution. In the pharmaceutical industry dissolution testing of solid dosage form gives a signal of the operability of the dosage form in the biological system. The rate of absorption is partially or completely controlled by the dissolution of the drug from its dosage forms in the gastrointestinal tract. Dissolution, the vital quality control aspects, also ensure batch-to-batch uniformity in drug release, bioavailability, and the development of efficacious therapeutic dosage forms. It also ensures the evaluation of their critical biopharmaceutical parameters. Hence the study of dissolution is an interplay between the science and the development of the regulatory profile of a dosage form for quality control aspects. The present review focuses on the science, factors relevant to in-vitro dissolution, and therefore the role of its in pharmaceutical regulation.