Design, development and optimization of self-nanoemulsified drug delivery system for poorly water-soluble drug by QbD approach

Abstract

The objective of the present study was to develop SNEDDS containing a poorly water-soluble drug by application of QbD principles. Two statistical designs were used to systematically understand the effect of various formulation variables in the development of SNEDDS. Initially, PB design was used as a screening design to identify the significant effect of six independent variables on the characteristics (globule size (nm), self-emulsification time (sec) and percent dissolution efficiency at 15min) of SNEDDS. Statistical results suggested oleic acid as a type of oil, Cremophor EL as a surfactant and Trancutol HP as co-surfactant but their respective amount in the isotropic mixture was found to in wider range. This allowed us to utility CCD to identify the optimal design space between the amount of oleic acid (X1), surfactant (X2) and co-surfactant (X3). The dependent variables studied were globule size (Y1) and self-emulsification time (Y2) and were fitted to the second-order quadratic model. A numerical optimization technique by desirability function was used to identify the optimal design space. The results demonstrate the feasibility of the model in the development of SNEDDS and the same can be extrapolated to other poorly water-soluble drugs.