Effect of Formulation Variables on Pharmacotechnical Properties of Carvedilol Self-Emulsifying Drug Delivery System

In the present work, self-emulsifying drug delivery system was formulated using Oleic acid (oil) and Tween 80 (surfactant). Carvedilol is a poorly water soluble drug and its bioavailability is very low. A new self-emulsifying drug delivery system (SEDDS) has been developed to increase the solubility, dissolution rate, and ultimately oral bioavailability of carvedilol. The solubility of carvedilol was determined in various vehicles. Pseudo ternary phase diagrams were used to evaluate the self-emulsification existence area. The developed SEDDS were evaluated for phase separation, turbidity, particle size, in vitro dissolution study. The release rate of carvedilol was investigated. The release rate was accelerated by decreasing droplet size, and was significantly faster as the particle size decreased. The particle size of formulation consisting of oleic acid 10%, Tween 80 90% and carvedilol 12.5 mg was found to be 41.72 nm and released more than 90% of drug within 30 min. The reduced particle size improved the self-emulsification performance of SEDDS in 0.1N hydrochloric acid pH 1.2 and phosphate buffer solution pH 6.8. The developed SEDDS formulation can be used as an alternative to traditional oral formulations of carvedilol to improve its bioavailability.