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Abstract

FORMULATION AND IN- VITRO EVALUATION OF ALFUZOSIN HCL FLOATING TABLET

Hemant Maheta, Dr.M.R.Patel, Dr.A.D.Patel

ABSTRACT

The purpose of this Research work was to prepare and optimized floating tablet of Alfuzosin HCl. Alfuzosin HCl is an alpha-1 adrenergic receptor blocker for the treatment of benign prostatic hyperplasia. Alfuzosin HCl exhibits narrow absorption window in the proximal part of the gastrointestinal tract & jejunum appear to be the main region for absorption. Alfuzosin HCl has a short biological half life (3-5 hours). The dose may range from 2.5 mg thrice a day to a maximum of 10 mg once a day which results into inconveniency to the patients. By preparing sustained release floating tablet of Alfuzosin HCl that deliver drug for longer time, reduce dosage frequency & better patient compliance. The present Research work describes the influence of the concentration of Xanthan Gum and Sodium bicarbonate on Alfuzosin HCl floating tablet using Central Composite Design. The Xanthan Gum (X1) and Sodium bicarbonate (X2) were selected as independent variables, while time required for 50% drug release (t50), time required for 90% drug release (t90), drug release at 12 hr (Q12), floating lag time, diffusion exponent (n), release rate constant (k) were selected as a dependent variables. Tablets were prepared by direct compression technique & evaluated for pre-compression and post-compression parameters. Dissolution data were fitted to various models to ascertain kinetic of drug release. Regression analysis and analysis of variance were performed for dependent variables. All the batches were evaluated for the pre-compression and postcompression parameters and results were within the limits. All the batches exhibited appropriate floating lag time & showed total floating time of more than 24 hrs. It was observed that concentration of Xanthan Gum and Sodium bicarbonate had significant influence on t50, t90, Q12, floating lag time, n, and k. Optimized formulation (H10) showed 99.52% drug release at the end of 24 hrs and maximum similarity factor (f2=83.15) and minimum dissimilarity factor (f1=2.80) with Theoritical release profile of Alfuzosin HCl. Optimized formulation followed by anomalous non Fickian release mechanism and found to be stable after 23 days at accelerated condition.

Keywords: Alfuzosin hydrochloride, direct compression, Floating tablet, Xanthan Gum, Guar Gum, Central Composite design.


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