Formulation-By-Design of Efinaconazole Spanlastic Nanovesicles for Transungual Delivery Using Statistical Risk Management and Multivariate Analytical Techniques

The study focused on optimizing efinaconazole spanlastic nanovesicles for transungual delivery to treat onychomycosis, using a Formulation-by-Design (FbD) approach combined with risk management and multivariate analysis. Efinaconazole, a poorly water-soluble antifungal drug, faced challenges in permeability, which spanlastic nanovesicles aimed to improve. The research identified critical formulation factors using the Ishikawa fishbone diagram and Plackett–Burman design, optimizing vesicle builder, edge activator, and mixing time to enhance particle size, transparency, deformability, and dissolution efficiency. The optimized formulation achieved a particle size of 197 nm, 91% transparency, 12.5 min relative deformability, and 81.23% dissolution efficiency. The study demonstrated the potential of spanlastic nanovesicles in enhancing drug delivery through nails.