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

The study aimed to optimize efinaconazole-loaded spanlastic nanovesicles for transungual delivery to treat onychomycosis, using a Formulation-by-Design approach with statistical risk management and multivariate analysis. Researchers identified critical quality attributes and process parameters, such as the type of edge activator (Tween 80), vesicle builder (Span 60), and sonication time, which significantly influenced particle size, encapsulation efficiency, and transungual penetration. The optimized formulation achieved a particle size of 197 nm and 81.23% dissolution efficiency, demonstrating enhanced drug delivery across the nail barrier. Ex vivo studies confirmed effective efinaconazole permeation, suggesting that spanlastic nanovesicles could be a promising platform for delivering poorly water-soluble drugs in transungual applications.