ABSTRACT:
The purpose of the study was to improve the Physicochemical properties of Mesalamine like solubility , dissolution properties and stability of a poorly water-soluble drug like Mesalamine by forming dispersions with polyvinylpyrrolidone (PVP), Polyethylene Glycol (PEG) and ß- Cyclodextrine as water-soluble carriers. The solid dispersion of Mesalamine by kneading method were prepared using 1:2 and 1:3 ratios of drug to polymers polyvinylpyrrolidone (PVP), Polyethylene Glycol (PEG) and ß-Cyclodextrin. The saturation Solubility study was carried out by using flask shaker method at room temperature. Dissolution study was conducted in 0.1N HCl at 370C ± 0.50C 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. The dispersion with ß Cyclodextrine (1:3) showed faster dissolution rate as compared to the other prepared dispersions. Characterization of Mesalamine solid dispersion was performed by Fourier Transform Infrared (FTIR) and X-ray powder diffractometry study. The stability studies performed on the mesalamine pure drug and optimized solid dispersion with ß- Cyclodextrins (1:3) in accelerated condition upto six months. The stability study reveals no significant variation in in-vitro dissolution study of optimized solid dispersion ß- Cyclodextrins (1:3) up to six month comparative to pure mesalamine drug.