Self-Nanoemulsifying Drug Delivery Systems of Poorly Soluble Drug Dutasteride: Formulation and In-Vitro characterization

The present study aims to prepare and evaluate the self-nanoemulsifying drug delivery system (SNEDDS) to enhance the dissolution rate of a poorly soluble drug dutasteride. The formulation was prepared using capryol PGMC, Cremophor EL, and polyethylene glycol (PEG) 400 as oil, surfactant and co-surfactant, respectively. The pseudo-ternary phase diagrams with presence and absence of drug were plotted to find out the nanoemulsification range and also to evaluate the effect of dutasteride on the emulsification behavior of the phases. Prepared SNEDDS formulations were evaluated for its particle size distribution, nanoemulsifying properties, robustness to dilution, self-emulsification time, turbidity measurement, drug content and in-vitro dissolution. Furthermore, the optimized formulations were evaluated for heating cooling cycle, centrifugation studies, freeze thaw cycling, particle size distribution and zeta potential to confirm the stability of the formed SNEDDS formulations. The particle size, zeta potential and polydispersity index of the optimized formulation was found to be 35.45 nm, -15.45 and 0.19, respectively. The in vitro results revealed that the prepared formulation enhanced the dissolution rate of dutasteride significantly compared to pure drug. In 60 minutes, the formulation showed 83.15% and 82.04 % drug release for pH 6.8 and pH 1.2 respectively. Based on the results, it was concluded that the dutasteride-loaded SNEDDS revealed better dissolution compared to the raw drug suspension and commercial drug.