Abstract

FORMULATION AND EVALUATION OF DARIFENACIN HBr EXTENDED RELEASE TABLETS

Vadiyala Ashok* and A. Seetha Devi

ABSTRACT

The objective of this study was to develop and evaluate Darifenacin Hydro bromide Extended Release matrix tablet by using various grades and ratios of hydroxy propyl methyl cellulose (HPMC), Xanthan gum, Ethyl cellulose as rate controlling hydrophilic polymers and bioequivalent testing with the innovator ENABLEX (prepared by Novartis Pharma, Europe). The drug was compatible with the formulation components. Hence Lactose Anhydrous, Di calcium Phosphate (DC grade), Xanthan gum, Ethyl cellulose, HPMCK4M, HPMCK100M, opadry orange were selected as excipients for the lab scale development. Blends were evaluated for various parameters such as bulk density, tapped density, Carr’s index, Hausner’s ratio and the parameters evaluated for the matrix tablet are Drug content, hardness, Friability, weight variation and Thickness and all physicochemical properties are within the limits. Drug release from tablets complies with the prescribed limits. Formulation development from F1 to F13 was executed to optimize the composition. At the final, the dissolution profile of the batches F11 was closer with the reference product. The stability studies were performed for the optimized formulation F11 at the accelerated conditions (400C/75% RH) for two months and at stress conditions (600C/90% RH) for one month. The results were indicated that all results were in limits after two months period. Hence the optimized formulation F11 was stable. Finally the combinations of high viscous and low viscous hydroxy propyl methyl cellulose polymers were used to develop a optimized formula that was similar with the innovators product ENABLEX.

Keywords: Darifenacin Hydro bromide, Extended Release Tablets, Dissolution profile, Controlled Release Polymers.