Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILM OF MESALAZINE

Ravi Singroli*, Rahul Sharma and Dr. Jagdish Chandra Rathi

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Abstract

Mesalamine is a derivative of salicylic acid (5-amino salicylic acid [5- ASA]) and also known as mesalazine. Mesalamine is categorized as a BCS class IV drug (low solubility, low permeability) according to the Biopharmaceutics Classification System. It is slightly soluble in water and poorly absorbed following its oral administration (approximately 25%). The aim of present work is to formulate and evaluate fast dissolving oral films of dolasetron mesylate to improve water solubility, dissolution rate, oral bioavailability and reduction of first pass metabolism and increase patient’s compliance. The present work deals with the investigations carried out on the preparation and characterization of fast dissolving tablets containing Meclizine with increase its bioavailability. The enhancement of solubility was done in different amount PEG 4000, On the basis of percentage cumulative drug release study it was concluded that solid dispersion is better option in spite of pure drug. Different formulation of Meclizine oral fast dissolving films were prepared and evaluated for Thickness, Weight, folding endurance, disintegration time, tensile strength moisture content and assay. The thickness of the Meclizine OFDFs formulations F1 – F6, developed with HPMC and superdisintegrants (SSG, CCS and CP) were found ranging from 42±4 μm to 62±5μm. From the obtained thickness data it was observed that the thickness of the film was increased by increasing in the concentration of the film former. Hence, the thickness of the film was directly proportional to its film former concentration. Cumulative % drug release was calculated on the basis of drug content of Meclizine present in the respective film. The results obtained in the in vitro drug release for the formulations were tabulated in table. The optimized formulations F-5 show drug release up to 98.85±0.23% at the end of 15min. The initial release of the optimized formulation was more (25.58±0.45); therefore the onset of action was very quick compare with the innovator product.

Keywords: Mesalazine, Fast dissolving films, Solvent casting method, Superdisintegrants.