DEVELOPMENT OF DICLOFENAC SODIUM CONTROLLED-RELEASE SOLID DISPERSION TABLET USING OPTIMIZATION STRATEGY

Directly compressed diclofenac sodium (DS) controlled release tablets were prepared from spray-dried DS controlled release solid dispersion of optimum dissolution profile. Optimization strategy using a central composite design and multiple regression was used to study the influen ces of four parameters; compression force, the amounts of spray-dried rice starch (Era-Tab(R)), croscarmellose sodium (Ac-Di-Sol(R)), and ma gnesium stearate, on tablet physical properties and dissolution. The o ptimum 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 t hat of the DS controlled release solid dispersion. The mechanism of dr ug release from the optimized DS tablet was found to be diffusion cont rolled.