SMEDDS (Self-MicroEmulsifying Drug Delivery System) As An Intraurethral Prostaglandin E1 Delivery System

Abstract

Prostaglandin E1 (PGE1) was formulated as two self-microemulsifying drug delivery systems (SMEDDS) composed of Cremophor ELRor Cremophor ELPR as a surfactant, ethanol as a cosurfactant and Labrafac CCRas an oil to develop liquid preparation for the treatment of erectile dysfunction. In pseudo-ternary phase diagram, viscous gel area and microemulsion area were defined. In the measurement of viscosity, the viscosity of two formulations increased gradually upon the addition of water and it decreased from the water contents over 40%. With excessive water, the present systems formed a microemulsion spontaneously. From these results, we could expect that the present liquid PGE1SMEDDS formulations might stay within the urethra in the viscous state when contacting the moisture of the urethra and can be easily eliminated by urination. In long-term stability study, we could select one formulation more stable at the shelf storage condition of 4oC.