A statistical approach for the development of an oral controlled-release matrix tablet.

Tablet matrix compositions for optimized prolonged release were selected by surface response methodology. The extreme vertices experimental design was used to develop a surface response model which mathematically defined the release of active component from the tablet matrix as controlled by the percentage of the excipient components. The model, a statistical quadratic equation with a standard error of 3.3, was validated for accurate prediction of drug release profiles and used to identify optimum formulations. This study demonstrated a new application of the extreme vertices experimental design, an efficient method for evaluating a complex mixture system for controlled release, where specific constraints are placed on one or more of the components.