Abstract

FORMULATION DEVELOPMENT OF VALSARTAN TABLETS: OPTIMIZATION BY 22 FACTORIAL DESIGN

Ch. Tarakaramarao and K. P. R. Chowdary*

Abstract

Valsartan, a widely prescribed anti hypertensive drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility. It needs enhancement in the dissolution rate in its formulation development. Complexation with β-cyclodextrin (βCD) and use of Crospovidone are tried for enhancing the dissolution rate of valsartan in its formulation development. The objective of the present study is optimization of valsartan tablet formulation employing βCD and Crospovidone by 22 factorial design. Formulation of valsartan tablets with NLT 85% dissolution in 10 min employing βCD and Crospovidone was optimized by 22 factorial design. Four valsartan tablet formulations were prepared using selected combinations of the two factors as per 22 factorial design. Valsartan tablets were prepared by direct compression method and were evaluated for drug content, hardness, friability, disintegration time and dissolution rate characteristics. The dissolution rate (K1) values were analysed as per ANOVA of 22 factorial design to find the significance of the individual and combined effects of the two factors (βCD and Crospovidone) involved on the dissolution rate of valsartan tablets formulated.

Keywords: Valsartan tablets, Optimization, ?-cyclodextrin, Crospovidone, Factorial Design.