Optimization of a Slow-Release Tablet Formulation Containing Sodium Sulfathiazole and a Montmorillonite Clay

Abstract

A slow-release tablet formulation containing high levels of a montomorillonite clay, Veegum F®, was initially developed by trial and error. The present study was undertaken to utilize an approach involving statistics with the aid of computer science to develop a formula with desired characteristics. An experimental design for five factors was employed. The five factors consisted of levels of various components and the amount of compressional force applied while tableting. The response or dependent variables included tablet weight uniformity, hardness and friability; and percent drug in solution after 3 hours of dissolution testing. The response variables were fitted to a second-order polynomial with the five formulation factors as the independent variables. The resulting equations were used to optimize the formulation with respect to the response variables. The results indicated that a formulation with the desired characteristics could be predicted by the technique.