Development of Diclofenac Sodium Controlled Release Solid Dispersion Tablet Using Optimization Strategy

Abstract

Directly compressed diclofenac sodium (DS) controlled release tablets were prepared from spray-dried DS controlled release solid dispersion of optimum dissolution projile. Optimization strategy using a central composite design and multiple regression was used to study the influences of four parameters: compression force, the amounts of spray-dried rice starch (Era-TabR), croscarmellose sodium (Ac-Di-Sol^R), and magnesium stearate, on tablet physical properties and dissolution. The optimum conditions of those parameters were searched and an optimum DS controlled release tablet formulation was formulated. The dissolution profile of the optimized DS controlled release tablet was similar to that of the DS controlled release solid dispersion. The mechanism of drug release from the optimized DS tablet was found to be diffusion controlled.