Formulation Optimization and In Vitro and In Vivo Preclinical Evaluation of Valsartan IR Tablets

The objective of the present study is optimization of Valsartan tablet formulation employing βCD, Starch 1500, and Soluplus by 23 factorial design to achieve NLT 85% dissolution in 10 min and to evaluate the optimized formulations by In Vitro and In Vivo (Preclinical) methods. Eight Valsartan tablet formulations were prepared using selected combinations of the three factors as per 23 factorial design. Valsartan tablets were prepared by direct compression method and were evaluated. The individual and combined effects of the three factors βCD, Starch 1500 and Soluplus are highly significant (P < 0.01) in influencing the dissolution rate of Valsartan tablets.Valsartan tablet formulations Fb,Fab, Fbc and Fabc disintegrated rapidly and gave very rapid dissolution of Valsartan, 92.4%, 99.4% ,96.2% and 99.2% in 10 min respectively. The increasing order of dissolution rate (K1 ) observed with various formulations was F1< Fc< Fa< Fac< Fb< Fbc< Fab