PHARMANEST : AN INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACEUTICAL SCIENCES - Volume 4, Issue 6, November - December 2013

Pages: 1645-1660

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FORMULATION AND EVALUATION OF EXTENDED RELEASE TABLETS OF DARIFENACIN HYDROBROMIDE

Author: R.RAVI TEJA*, G.CHIRANEEVI, Dr.V.UMAMAHESHWARA RAO, P.VISHNU

Category: Pharmaceutical Sciences

Abstract:

The objective of this research work was to develop extended release tablets of Darifenacin Hydrobromide using different hydrophilic polymers like HPMC K15M, HPMC K100M, Metalose60SH 50, Xanthan gum by direct compression method. Various amounts of polymers was used in the twenty one proposed formulations (F1to F21) for the study of release rate retardant effect at 15%, 20%, and 30% of total weight of tablet matrix respectively. Then the tablets were evaluated in terms of their physical parameters (weight variation, hardness, friability and thickness), drug content and in-vitro release studies. All the formulations showed compliance with pharmacopoeial standards, their in-vitro dissolution study were conducted using USP dissolution apparatus type-II (paddle method) in 900 ml 0.1 N HCl for first 2 hrs and remaining period performed in 7.4 pH phosphate buffer at 100rpm for a total period of 24hrs. The release mechanisms were explored and explained by Zero order, Higuchi, First order and Krosmeyer-Peppas equations. Based on the dissolution data comparison with innovator product, formulation F17 was found as the best formulation. The drug release profile of this formulation was well controlled and uniform throughout the dissolution studies. The drug release of formulation F17 followed First Order kinetic model and the mechanism was found to be non-Fickian/anomalous according to Korsmeyer-Peppas equation.

Keywords: Darifenacin Hydrobromide, Direct Compression, Hydroxy propyl methyl cellulose, Metalose 60SH 50, Extended Release