Formulation And Evaluation Of Self Emulsifying Drug Delivery System

Abstract

The aim of the present study was to formulate and evaluate self -emulsifying drug delivery system of Fenofibrate and Glimepride. For screening purpose, the solubility of glimepiride and fenofibrate in various oils (Lipids), surfactants and co-surfactants were determined to select a suitable combination of these ingredients. Flow and compressive strength have been shown to depend on the carrier and drying process. Emulsification efficiency was determined and also pseudo-ternary phase diagrams were constructed. Formulated S-SNEDDS, prepared by spray drying using Aerosil® 200 as a hydrophobic carrier, provides nanoemulsions with small particle sizes and drug release when subjected to different stresses such as depressed thermodynamic conditions and forever freeze-thaw. In vitro dissolution studies have shown that L-SNEDDS and S-SNEDDS are more effective than crude glimepiride. SEM showed that crystalline glimepiride was present in a transitional amorphous state in SNEDDS formulations prepared with Aerosil® 200 as a vehicle. For the formulation of fenofibrate SNEDDS, Capmul MCM as oil, Cremophor RH 40 as surfactant and Transcutol-P as co-surfactant were used as pre-test. Global size (GS), zeta potential (ZP), polydispersity index (PDI), and 15-minute fenofibrate release. A batch containing 0.471 ml of Capmul MCM oil, 1.608 ml of Cremophor RH 40: Transcutol-P (3:1) was selected as the best formulation of SNEDDS. The optimized process was subjected to in vitro dissolution for evaluation of drug release compared to the commercial product. The stability study of the refined product was carried out at room temperature and 40°C and 75% relative humidity. The optimum concentration was found to be stable, with more than 90% of the solution dissolved in 15 minutes. The ideal goal can be achieved as soon as possible by establishing a standardized procedure while reducing the number of tests for fenofibrate formulation development.