History and Evolution of the Dissolution Test

INTRODUCTION The release of the drug substance from a solid dosage form has a major impact on its rate and extent of absorption. In certain instances, as is the case with modified-release formulations, the rate-limiting step in the appearance of the drug in the systemic circulation is its release from the formulation. In the vast majority of cases, in vitro dissolution of an immediate-release product is one of the most important tools in assuring the batch-to-batch quality of the drug product. Establishing appropriate dissolution specifications will assure that the manufacture of the dosage form is consistent and successful throughout the product’s life cycle and that each dosage unit within a batch will have the same pharmaceutical qualities that correspond to those shown to have an adequate safety and efficacy profile. Due to the critical role that dissolution plays in the bioavailability of the drug, in vitro dissolution can serve as a relevant predictor of the in vivo performance of the drug product. This article discusses the history as well as the evolution of dissolution and its role in the drug development and approval process