Formulation Development and Evaluation of Poorly Water Soluble Gliclazide Tablet Containing Aerosil 380 as Carrier

Abstract

The core objective of the current work was to improve dissolution rate of poorly water-soluble anti-diabetic drug gliclazide by solid dispersions (SDs) technique using fumed silica particles Aerosil 380 as carrier into compressed tablets. Different FGA-1, FGA-2, FGA-3 (Formulated Gliclazide Aerosil; weight ratio, 1:1) and FPG-1, FPG-2 (Formulated Plain Gliclazide) tablet batches were formulated, prepared, evaluated and characterized. All the findings of pre-compression factors were found to be satisfactory and post-com - pression parameters revealed good mechanical integrity and good uniformity in all formulations. All the formulated tablets satisfied the compendia limits of weight variation, friability and the disintegration time. Among all formulations, FGA-3 was optimized based on in vitro drug release findings, disintegration time, hardness and other quality attributes. The percent of drug release from the formulated FGA tablets containing gliclazide loaded aerosil is about 3 fold higher when compared with the tablets formulated and prepared with plain gliclazide (FPG) and the tested commercial brands in first 60 minutes. There was no significant change noted in the drug content and drug release pattern in the FGA tablets batches when stored in 40 ℃ and 75% RH for three months. It was thus concluded that SDs formulations of gliclazide could be successfully used to design and develop a solid dosage form of the drug, which would have significant benefits over the existing commercial brands.