Formulation Optimization of Sustained-Release Tablet of Chlorpheniramine Maleate by Means of Extreme Vertices Design and Simultaneous Optimization Technique

Abstract

Formulation optimization of sustained-release tablet of chlorpheniramine maleate (CPM) was performed by means of an extreme vertices design and simultaneous optimization technique. Polyvinylpyrrolidone, carboxyvinyl polymer and crystalline cellulose were used as excipients of the tablet. Mixing ratios of these polymers were selected as formulation factors. In addition, the tablet diameter was employed as an independent process variable. Release parameters of CPM in the model formulations were estimated by using an exponential model for the drug diffusion. These parameters were selected as response variables and optimized by the simultaneous optimization technique. Response variables predicted with the optimum formulations agreed well with the experimental results, suggesting usefulness and reliability of the computer optimization method based on the extreme vertices design and simultaneous optimization technique. © 1992, The Pharmaceutical Society of Japan. All rights reserved.