Formulation and Optimization of Fluvastatin Loaded Self-emulsifying Drug Delivery Systems
Main Article Content
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 Boxâ€“
Behnken design employing the study factors â€“ the amount of sefsol-218 (a), Cremophor RH40 (b), and propylene
glycol (c) and responses â€“ droplet size (DS) (Y1), zeta potential (Y2), and cumulative percentage of drug release
after 60 min (Y3). Results: The results revealed that FVT8 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 nm and zeta potential of â€’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 nanometer 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.
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