Abstract

in vitro dissolution tests were traditionally designed for quality control. USP methods commonly used to evaluate the release rate of new controlled release dosage forms are often based on such experiments. The need to design a new in vitro experiment arises when a suitable in vitro – in vivo correlation cannot be obtained because in vivo release is significantly different from in vitro experiments. Modern simulation methodology offers new solutions to this problem. The application of state-of-the-art simulation methods for the numerical deconvolution of in vivo release profiles is combined with simulation software for the detailed mechanistic simulation of in vitro dissolution experiments to produce a method for optimizing in vitro experimental conditions (instrument speed, pH, and fluid volume) as functions of time in order to replicate deconvoluted in vivo release behaviors.

Controlled Release Society (CRS) Annual Meeting and Exposition, July 7-11, 2007, Long Beach, California

By Walter S. Woltosz, Viera Lukacova, A Prabhakaran, John DiBella, and Michael B. Bolger