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Abstract

DESIGN AND DEVELOPMENT OF VALSARTAN TABLET FORMULATIONS FOR ANTIHYPERTENSIVE BY 2³ FACTORIAL DESIGNS

Ch. Taraka Ramarao* and K. Reshma

ABSTRACT

The individual main effect and combined effect of commonly used β Cyclodextrin, Binders, disintegrants on the dissolution rate of valsartan tablets were studied in 23 factorial designs employing selected combinations of three factors (β Cyclodextrin, Binders, disintegrants) of eight formulations of valsartan tablets were prepared and evaluated for various physical properties, dissolution rate and dissolution parameters from the results obtained the following conclusions are drawn. All the prepared granules were studied for flow properties such as bulk density, true density, compressibility index to achieve excellent to good flow properties. All the valsartan tablets were prepared good quality with regard to drug content, hardness, friability and disintegration time to fulfill official (IP) specifications of uncoated tablets. The valsartan tablets dissolution from all the tablets prepared followed first order kinetic model. The correlation coefficient (r) value higher than zero order kinetic models in all cases. Many variations were observed in all the dissolution parameters of tablets prepared due to formulation variables. The ANOVA of dissolution rate (K1) indicates the individual main effect and combined effect of β Cyclodextrin, Binders, disintegrants on the dissolution rate constant (K1) are significant (P < 0.05). The ANOVA of dissolution efficiency (DE30) indicates that individual main effect and combined effect of β Cyclodextrin, Binders, disintegrants on the dissolution efficiency (DE30)are significant (P < 0.05). Valsartan tablets formulations Fabc formulated employing 1:2 ratio of β Cyclodextrin (Factor A) and Gelatin (2%) as a Binder (Factor B) and Cross Carmellose Sodium (5%) as Disintegrant (Factor C) gave highest dissolution rate of Valsartan 97.5% in 60 min. The increasing order of dissolution rate observed with various formulations was Fabc > Fbc > Fc > Fac > Fab > Fb > Fa > F1. The optimize valsartan tablets (Fabc) formulated employing1:2 ratio of β Cyclodextrin, Gelatin (2%) and Cross Carmellose Sodium (5%) are compare to the marketed product (Valent 80). The differential factor (f1) valued found 5.776 and similarity factor (f2) value found 75.291. Differential factor (f1) and similarity factor (f2) indicate identical/similar dissolution profile comparable to marketed product (Valent 80)

Keywords: ? Cyclodextrin, Factorial Design, ANOVA, Binder and Disintegrant.


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