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Abstract

The purpose of the study was to improve the physicochemical properties of Mesalamine like solubility and dissolution rate by forming solid dispersions with sodium lauryl sulphate (SLS) and Urea (UR) as water-soluble carriers. The solid dispersion of Mesalamine by kneading method were prepared using 1:1, 1:2 and 1:3 ratios of drug to polymer using methanol as solvent. Characterization of Mesalamine solid dispersion was performed by Fourier Transform Infrared (FTIR) spectroscopy and X-ray powder diffractometry study. FTIR spectra reveal that there was no drug -carrier interaction and absence of Mesalamine peaks in XRD profile suggests the transformation of crystalline Mesalamine to amorphous form. The saturation Solubility study was carried out by using flask shaker method at room temperature. Dissolution study was conducted in 0.1N HCl at 37 o C ± 0.5 o C using USP type II (paddle) type dissolution apparatus. The prepared dispersion showed marked increase the saturation solubility and dissolution rate of Mesalamine than that of drug alone. Therefore the dissolution rate of poorly water soluble drug Mesalamine can be significantly enhanced by the preparation of solid dispersion using SLS and UR by kneading technique. INTRODUCTION:Mesalamine is 5-amino salicylic acid, active moiety of sulphasalazine. Its major indications are to treat mild to moderate acute exacerbations of ulcerative colitis's in remission, particularly in patients intolerant of sulphasalazine. It is white to pinkish crystals slightly soluble in water, 20 to 30 % absorbed following oral administrations.