Fabrication Development and Characterization of Extended Release Film Coated Formulation of Antimuscarinic Agent for the Treatment of Irritable Bowel Syndrome (IBS)

Abstract The aim of this current study was to develop extended release matrix film coated tablets of mebeverine hydrochloride to augment the therapeutic efficacy, diminish the frequency of administration and get better the patient compliance. The matrix film coated tablets were fabricated by wet granulation method, using different polymers such as Hydroxyl propyl methyl cellulose (HPMC K15M), Eudragit, Microcrystalline cellulose pH 101 (MCC) alone or in combinations and other standard excipients. Drug compatibility with excipients was checked by FTIR studies.  The powder blend was subjected for pre compressional parameters such as bulk density and tapped density, angle of repose, compressibility index and Hausner’s ratio. 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, Further, tablets were evaluated for in-vitro release characteristic for 12 h. Tableting of granules was showed good flow properties and fabricated tablets were exhibited desired compressibility characteristics. Formulation SRTM3 exhibited an in-vitro drug release up to of 90 % and the release kinetics of drugs was best explained by First order kinetic model and the mechanism was found to be non-Fickian/anomalous according to Korsmeyer-Peppas equation.

Keywords Antimuscarinic agent, HPMC, Sustained release, Irritable bowel syndrome, Stability studies

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Updated: April 17, 2016 — 2:07 pm