Statistical Optimization of Orodispersible Tablets Containing Telmisartan Using Factorial Design and Response Surface Methodology

This study investigated utility of a 3² factorial design and Response Surface Methodology for orodispersible tablets containing Telmisartan. In an attempt to construct a statistical model for the prediction of disintegration time and percentage friability, a 3² factorial design was used to optimize the influence of the amounts of superdisintegrant (Polacrilin Potassium), X₁ and subliming agent (Camphor), X₂ which were independent variables. Tablets were prepared by direct compression with camphor sublimation method. Based on the experimental design, different drug release rates and profiles were obtained. Mathematical equations and response surface plots were used to relate the dependent and independent variables. The obtained results showed that dispersion of the drug in the polymer considerably enhanced the dissolution rate. Concerning the optimization study, the multiple regression analysis revealed that an optimum concentration of camphor and higher concentration of Polacrilin potassium are required for obtaining rapidly disintegrating tablets. Hence, this investigation demonstrated the potential of the experimental design in understanding the effect of the formulation variables on the quality of orodispersible tablets containing Telmisartan.