Design and Development of Fast Dissolving Tablet of Gliclazide

Abstract

In the present study, Gliclazide is a second-generation sulfonyl urea derivative used to treat non-insulin dependent diabetes mellitus. The drug has been classified as class-II drug according to biopharmaceutical classification system having low solubility and high permeability. So, an attempt was made to enhance the solubility of gliclazide by solvent evaporation technique. A significant enhancement of gliclazide dissolution rate will be obtained using by using suitable techniques. In this PVP-k30, polyethylene glycol and soluplus were mixed with the drug in different ratios (1:1, 1:3) and prepare P1, P2, PE1, PE2, S1 and S2 solid dispersion batches. The optimized solid dispersions P1 were further kneaded with suitable proportions of super disintegrants such as; Cross carmellose and Sodium starch glycolate. Dissolution profile will show decrease amount of drug release at specified time. DSC as well as X-ray diffraction showed reduced drug crystallinity in SDs. Scanning electron microscopy and particle size analysis revealed significant decreased particle size of the drug in SDs. FT-IR spectroscopy demonstrated no detectable interactions between the drug and excipients. On that the P1 batch will be consider for eight different fast dissolving tablets Preparation. The prepared FDT’s were evaluated for various parameters like disintegration time, wetting time, drug content, in vitro drug release study etc. and shows the satisfactory result. The formulation of F-4 containing cross carmellose sodium (5%) showed better result in disintegration time 11 sec. and maximum in vitro drug release of 99.89% at the end of 40 minutes.