Development, Characterization and Optimization of Ibuprofen Self-emulsifying Drug Delivery System Applying Face Centered Experimental Design

Ibuprofen (IB) a NSAID, has poor dissolution and many gastrointestinal side effects. Self-Emulsifying drug delivery system (SEDDS) has proved its efficacy to improve the solubility and dissolution of many lipophilic drugs and improve their characteristics. The objectives of this study were to develop, optimize and characterize a IBSEDDS applying Face Centered Experimental Design (FCED). The methods included determination of solubility of IB in different oils, surfactants and co-surfactants. Ingredient showing high drug solubility were used to formulate several IBSEDDS after being tested for physical and chemical compatibility with the drug. A three factor, three level FCED was used for the optimization process. The concentration of oil, surfactant and cosurfactant were the independent variables, X1, X2 and X3 respectively, while the dissolution, turbidity and droplet size were the dependent variables, Y1, Y2 and Y3 respectively. The results showed high solubility and compatibility of IB with soybean oil, Cremophore EL and Capmul MCM-C8. The concentrations of X1X3 showed significant effects on the responses Y1-Y3.The polynomial equation relating the response Y1 and variables X1-X3 was obtained. The optimized and predicted values of Y1 were in close agreement. According to the design, 50% X1, 40% X2 and 10% X3 maximized Y1 up to 100% after 60 min. In conclusion, IBSEDDS with high drug release and reasonable physical properties could be prepared and the experimental design applied helped in understanding the effects and the interaction effects between the three variables applied. The optimized formulation is expected to show high bioavailability with minimal side effects.