Solubility enhancement of Nebivolol via Self emulsifying drug delivery system using Box–Behnken Design: Optimization and Evaluation

Abstract

The present study aimed to develop, optimize, and evaluate a Nebivolol-loaded self-emulsifying drug delivery system (NSEDDS) to improve the drug's solubility, dissolution rate, and oral bioavailability by employing a Quality by Design (QbD) approach to manage high blood pressure. N-SEDDS formulations were prepared in thirteen batches NS1-NS13, using Capryol 90 (oil phase), Tween 80 (surfactant), and PEG 400 (co-surfactant). No interaction with excipient was observed with drug by FTIR compatibility study. Formulations were optimized using Box–Behnken Design and evaluated for droplet size, polydispersity index (PDI), zeta potential, pH, Refractive index (RI), %Transmittance, Cloud point, Emulsification time, Thermodynamic stability, Drug content, Cumulative % in vitro drug release. Among all formulations, NS2 was identified as the optimized batch, exhibiting a droplet size of 109.8±0.13 nm, PDI of 0.113, zeta potential of −29.4 mV, drug content of 93.12±0.43%, and cumulative % in vitro drug release of 95.66±0.35% after 120min. The optimized formulation also demonstrated excellent physical stability, rapid emulsification, and thermodynamic stability. In conclusion N-SEDDS could be a better approach for solubility and bioavailability enhancement in oral, topical, parental route in the management of hypertension.