Pharmacology & Pharmacy | 2019
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 \nimprove dissolution rate of poorly water-soluble anti-diabetic drug gliclazide \nby solid dispersions (SDs) technique using fumed \nsilica 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. \nAll the findings of pre-compression factors were found to be satisfactory and \npost-com- pression parameters revealed good mechanical integrity and good uniformity in all formulations. All the formulated tablets \nsatisfied the compendia limits of weight variation, friability and the \ndisintegration time. Among all formulations, FGA-3 was optimized based on in \nvitro drug release findings, disintegration time, hardness and other \nquality attributes. The percent of drug release from the formulated FGA tablets containing gliclazide loaded aerosil is about 3 fold higher when \ncompared with the tablets formulated and prepared with plain gliclazide (FPG) \nand the tested commercial brands in first 60 minutes. There was no \nsignificant change noted in the drug content and drug release pattern in the FGA tablets batches when stored \nin 40℃\xa0and 75% RH for three months. It was thus concluded that SDs formulations of \ngliclazide could be successfully used to design and develop a solid dosage form \nof the drug, which would have significant benefits over the existing commercial brands.