DEVELOPMENT AND EVALUATION OF PRONIOSOMAL GEL FOR ENHANCING THE TRANSDERMAL DELIVERY OF EFINACONAZOLE

Objectives: The aim of this study was to formulate proniosomes of the antifungal drug efinaconazole to improve its transdermal/topical delivery. Methods: Proniosomes were prepared using the coacervation phase separation technique. The ideal formulation was selected based on the desirability criterion. Various evaluations were conducted on the optimized formulation, including tests for stability, ex vivo permeability, in vitro release, skin irritation, surface morphology, and transmission electron microscopy (TEM). The formulation incorporated cholesterol (412.5 mg) and soy lecithin (50 mg), achieving a high encapsulation efficiency. Hydroxypropyl methylcellulose (K4M) was utilized as a polymer in the formulation. Results: The encapsulation efficiency for cholesterol and soy lecithin reached 82.26%, with the vesicle size measuring 48.32 nm. In vitro release studies demonstrated a sustained release of the drug. Ex vivo experiments revealed significant differences in the flux of efinaconazole between excised epidermis and membranes. Analysis of surface morphology showed a quick transformation of the proniosomal gel into niosomes. TEM images confirmed the formation of spherical niosomes. The formulations displayed low polydispersity indices (<0.358), indicating uniformity. High zeta potential values prevented flocculation and aggregation, ensuring the stability of the system. Stability testing validated the safety profile of the formulation. Conclusion: The proniosomal formulation containing efinaconazole exhibited promising potential for enhanced transdermal delivery. The results suggest that this formulation offers improved stability, controlled drug release, and effective permeation, making it a viable candidate for antifungal therapy.