Jasjeet K. Sahni

The aim of this study is to develop and characterize a solidified self-emulsifying formulation of glimepiride, and to compare its in vitro drug release profile to a commercially available tablets. Several self-emulsifying formulations (SEF) were prepared by selecting different combination from constructed pseudoternary phase diagram. Selected formulations SEF1, SEF2 and SEF3 were solidified using crospovidone and evaluated. Following emulsification, the optimized formula was selected to have the smallest mean particle size and the highest absolute zeta potential, which should yield the formation of a stable emulsion and its superiority in dissolution characteristics. Particle size and distribution of SEF1, SEF2 and SEF3 were 423.36nm, 159.128nm and 115.899nm respectively. Zeta potential analysis revealed  that SEF3 had highest zeta potential – 43.78mV followed by -39.2mV (SEF2) and -39.08mV (SEF1). In vitro drug release in 30 min of formulation SEF1, SEF2 and SEF3 were 75.31%, 83.48% and 93.03% respectively. Which indicated superiority of SEF3. In vitro studies were also performed to compare the optimized formula, SEF3, to a commercially available Betaglim tablet. T50% of glimepiride in SEF3 and betaglim was found to be 7 min and 22 min respectively. Which indicated a significant improvement in glimepiride release characteristics. SEF3 was found to be stable under stressed conditions. However slightly increased globules size of sample stored at accelerated storage condition for 12 weeks was observed.