FORMULATION AND IN VITRO EVALAUATION OF TABLET CONTAINING GLICLAZIDE NANOCRYSTALS FOR SOLUBILITY AND DISSOLUTION ENHANCEMENT USING SOLUPLUSAbstract
Poor aqueous solubility is the main problem in development of effective formulation which affects stability and bioavailability of drug formulation. So there is need of systematic formulation approach to make such poorly soluble drugs bioavailable. In the present investigation attempt has been made to investigate the effect of soluplus on solubility of gliclazide by preparing its nanocrystals. Nanocrystals of gliclazide with soluplus were prepared by using drug: carrier ratios of 1:0.5, 1:1, 1:2, 1:4, 1:6 and 1:8 by anti-solvent precipitation technique. Physiochemical analysis demonstrated the crystalline nature of particles and amongst all formulations 1:2 ratio provided the highest degree of gliclazide solubility i.e., 2.5027±0.77mg/ml as compared to pure drug 0.4918±0.51mg/ml. This increase in solubility may due to increase in surface area and or characteristics of nanocrystals and soluplus. The prepared nanocrystals were characterized by Fourier Transformed Infrared Spectroscopy (FTIR), Differential Scanning Colorimetry (DSC), X-Ray Diffraction pattern (XRD), Scanning Electron Microscopy (SEM). The prepared nanocrystals with highest solubility was formulated into tablet and evaluated for hardness, friability, drug content, disintegration time and in vitro dissolution. The tablet containing nanocrystals found to possess more drug release (88.84%) as compared to tablet containing pure drug (63.03%) and marketed formulation (64.43%).