Design, optimization and evaluation of clozapine tablets by response surface analysis

Abstract

The purpose of this work was, applying experimental design methodology on tablet formulation development by direct compression, to evaluate the influences of magnesium stearate and sodium croscarmelose quantities upon clozapine tablets, by a Central Composite Design. The results were fitted to non-linear regression and a second order equation was used to plot response surface graphics. The results showed that hardness and friability were influenced by magnesium stearate quantities, decreasing the mechanical resistance of tablets, and the sodium croscarmelose quantities caused a linear decreased on disintegration time and a increased on dissolution efficiency of tablets, on the studied experimental field.