Unlocking the Delivery Potential of Lutein: Development and Optimization of a Liquid Self-Emulsifying Drug Delivery System

Abstract

The present study aimed to design, optimize, and systematically evaluate a liquid self-emulsifying drug delivery system (L-SEDDS) of lutein to accelerate solubility and dissolution rate. L-SEDDS formulations were formulated using medium-chain triglyceride oil (oil phase), Tween 80(surfactant), and Span 20(co-surfactant) based on solubility studies to optimize the formulation; the effects of oil and Smix concentrations on drug release and emulsification time were assessed using a 3² factorial design. The optimized formulation showed a desirability of 0.912, and the optimization research showed that increasing Smix concentration and decreasing oil content greatly improved drug release and decreased emulsification time. The optimized (F5) L-SEDDS contains 20% oil and 80% Smix it consisted of a viscosity of 132 mPas, drug content of 98.67%, and emulsification time of 34 seconds. Dissolution in pH 6.8 phosphate buffer demonstrated a cumulative drug release of98.89% within 30 minutes. The mean droplet size was 462.8nm with a PDI of 0.379, and -39.4mV zeta potential showed good stability of the formulation. The formulation remained stable at accelerated storage conditions with no significant change in emulsification time or dissolution behavior.