Formulation optimization of finasteride proniosomes using response surface methodology

Abstract

Introduction: Finasteride is an orally administered medication for male pattern hair loss (MPHL). It is the only specific MPHL treatment approved by the U.S. Food and Drug Administration for prescription. The most common side effects reported with orally taken of finasteride are decreased libido and impotence. In order to overcome these side effects, topical formulation of finasteride proniosomes was developed using response surface methodology. Material and method: Finasteride loaded proniosomes were prepared by coacervation phase separation method. The response surface methodology using the central composite rotatable design was used to optimize formulation of finasteride proniosomes. The method consisted of three factor factorial designs with three levels include cholesterol concentration (X-₁) of 30-50 %, total lipid content (X₂) of 10-30 mM, and finasteride concentration (X₃) of 1.5-5 mM. Results: The optimized proniosome formulation was found at cholesterol concentration of 39.03 %, total lipid content of 20.26 mM, and finasteride concentration of 3.39 mM. The experimental values of the optimized formulation exhibited mean particle size of 292 + 0.85 nm, drug loading capacity of 13.14 + 0.18 %, and encapsulation efficiency of 94.47± 1.67 %. Comparison of the experimental values with those of the predicted values was almost identical with low percentage bias of particle size, drug loading capacity, and encapsulation efficiency of 0.11 %, 0.68 %, and 0.15 %, respectively. Conclusion: The response surface methodology with central composite rotatable design was an efficient method for optimization of finasteride proniosomes.