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Abstract

OPTIMIZATION OF VALSARTAN TABLET FORMULATION BY 23 FACTORIAL DESIGN

K. P. R. Chowdary*, K. Ravi Shankar and P. Suneel Kumar

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), use of Primojel and PVP K 30 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 Primojel, βCD and PVP K 30 by 23 factorial design. Formulation of valsartan tablets with NLT 85% dissolution in 10 min employing Primojel, βCD and PVP K 30 was optimized by 23 factorial design. 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 for drug content, hardness, friability, and disintegration time and dissolution rate characteristics. The dissolution rate (K1) values were analysed as per ANOVA of 23 factorial design to find the significance of the individual and combined effects of the three factors (βCD, Primojel and PVP K 30) involved on the dissolution rate of valsartan tablets formulated. ANOVA of K1 values indicated that the individual and combined effects of the three factors, βCD, Primojel and PVP K 30 in influencing the dissolution rate of valsartan tablets are highly significant (P < 0.01). Valsartan tablet formulations PFa and PFac disintegrated rapidly with in 1min and gave very rapid dissolution of valsartan, 100% in 10 min. Higher levels of βCD and lower levels of Primojel gave low dissolution rates of valsartan tablets. The increasing order of dissolution rate (K1) observed with various formulations was PF a = PFac > PFab > PFabc >PFbc> PFb > PFc > PF1. The polynomial equation describing the relationship between the response i.e. percent drug dissolved in 10min (Y) and the levels of Primojel (X1) , βCD (X2) and PVP K 30 (X3) based on the observed results is Y = 56.146 + 37.478(X1) + 1.676(X2) – 5.288(X1 X2) + 1.563(X3) - 2.942(X1 X3) – 1.123(X2 X3) - 0258(X1 X2 X3). Based on the above polynomial equation, the optimized valsartan tablet formulation with NLT 85% dissolution in 10 min could be formulated employing Primojel at 26.77% of drug content, βCD at 1:3 ratio of drug: βCD and PVP K 30 at 1% of drug content. The optimized valsartan tablet formulation gave 87.23% dissolution in 10min fulfilling the target dissolution set. The dissolution profile of the optimized valsartan tablet formulation was similar to that of a commercial brand (Valent 40). Hence formulation of valsartan tablets with NLT 85% dissolution in 10 min could be optimized by 23 factorial design.

Keywords: Valsartan tablets, Optimization, ?-cyclodextrin, Primojel, PVP K 30, Factorial Design


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