Self-emulsifying drug delivery system

Self-emulsifying drug delivery system (SEDDS) is an isotropic mixture of drug, oil, surfactant and co-surfactant which spontaneously forms emulsion in aqueous environment under gentle agitation. Many drugs are lipophilic in nature making them difficult for oral delivery as the GI environment is aqueous in nature. The objective of present work was to develop and evaluate the SEDDS of Aceclofenac using oleic acid as oil, tween 20 as surfactant and PEG 400 as  co-surfactant. Compatibility studies showed no interaction between drug and excipients used. Ternary phase diagram was constructed to optimize the formulation. Formulated SEDDSs were evaluated for drug content, zeta-potential, robustness to dilution, globule size and in-vitro drug release. Globule size were between 151.1-182.3 nm and spherical in shape. In-vitro drug release study revealed that the drug release form the formulated SEDDSs were faster when compare to pure drug and marketed product. Formulation S6 showed the highest drug release i.e. 91.71% within 25 m. Formulations were stable during testing period of 3 months. From this work, it was cleared that the SEDDS of Aceclofenac was found to be significant in terms of releasing of the drug as compare to pure drug and marketed product.

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.