ABSTRACT
Over the last quarter century the dissolution test has emerged as a most powerful and valuable tool to guide formulation development, monitor the manufacturing process, assess product quality, and in some cases to predict in vivo performance of solid oral dosage forms. Under certain conditions, the dissolution test can be used as a surrogate measure for bioequivalence (BE) and to provide biowaivers, assuring BE of the product. Dissolution test has turned out to be a
critical test for measuring product performance. Generally, dissolution testing of solid oral dosage form is carried out by the basket (USP Apparatus 1) or paddle (USP Apparatus 2) method under mild agitation (100 rpm with the basket or 50-75 rpm with the paddle), in an aqueous buffer in the pH range 1.2-6.8. Dissolution samples are analyzed at 15 min intervals for immediate-release (IR) products or at hourly intervals for extended-release products until at least 85% dissolution is achieved. For water-insoluble drug products, small amounts of surfactants are often employed to achieve sink conditions.
