A brief review on pharmaceutical dissolution - interlinking the aspects of science and regulation.

Dissolution is a multistep process between 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 pharmaceutical industry dissolution testing of solid dosage form gives a signal of the operability of the dosage form in biological system. The rate of absorption is partially or completely controlled by the dissolution of drug from its dosage forms in the gastrointestinal tract. This vital quality control aspects also ensures batch to batch uniformity in drug release, bioavailability, and to develop efficacious therapeutic dosage forms. It also ensures to evaluate critical biopharmaceutical parameters of the dosage forms. Hence the study of dissolution is an interplay between the science and the development of regulatory profile of a dosage form for quality control aspects. The present review focuses on the science, theories, factors relevant to in vitro dissolution, and therefore the role of it’s in the pharmaceutical regulation.