Formulation and Optimization of Fluvastatin Loaded Self-emulsifying Drug Delivery Systems

Introduction: The current research is aimed at formulating and evaluating fluvastatin self-nanoemulsifying drug delivery system (SNEDDS). Materials and Methods: Fluvastatin SNEDDS formulated using sefsol-218 (oil), Cremophor RH40 (surfactant), and propylene glycol (cosurfactant). The optimal concentration of excipients confirmed by self-emulsification region of pseudo-ternary phase diagram. Fluvastatin SNEDDS optimized by Box-Belurken design employing the study factors - the amount of sefsol-218 (a), Cremophor RH40 (b), and propylene glycol (c) and responses - droplet size (DS) (Y1), zeta potential (Y2), and cumulative percentage of drug release after 60 min (Y3). Results: The results revealed that FVTS comprising 30% sefsol-218, 50% Cremophor RH40, and 35% propylene glycol have close agreement between predicted and observed values. The optimized formulation FVT8 exhibited enhanced drug release with minimum DS of 22.1 mu and zeta potential of -6.7 mV and maximum drug release 98.62%. The Fourier transform infrared studies indicated no significant interaction among the drug and formulation excipients used: SEM data revealed that particle size is in manometer range with a Zeta potential indicating higher absorption and stability. Conclusion: Hence, the results revealed that the use of SNEDDS formulation for fluvastatin increased solubility. dissolution rate and has potential to enhance the bioavailability.