Onychomycosis is the most common
fungal infection of the nail affecting the skin under the fingertips and the toes. Currently, available
therapy for
onychomycosis includes oral and topical
therapies, either alone or in combination. Oral antifungal medication has been associated with poor
drug bioavailability and potential gastrointestinal and systemic side effects. The objective of this study was to prepare and evaluate the
luliconazole nail lacquer (LCZ-NL) for the effective treatment of
onychomycosis. In the current work, LCZ-NL was formulated in combination with penetration enhancers to overcome poor penetration. A 32 full factorial formulation design of experiment (DOE) was applied for optimization of batches with consideration of dependent (drying time, viscosity, and rate of
drug diffusion) and independent (
solvent ratio and film former ratio) variables. The optimized formulation was selected based on drying time, viscosity, and rate of
drug diffusion. The optimized formulation was further evaluated for % non-volatile content assay, smoothness of flow, water resistance, drug content, scanning electron microscope (SEM), atomic force microscope (AFM), X-ray diffraction (XRD), differential scanning calorimetry (DSC), in vitro drug release, ex vivo transungual permeation, antifungal efficacy, and stability study. The optimized LCZ-NL contained 70:30
solvent ratio and 1:1 film former ratio and was found to have ~ 1.79-fold higher rate of
drug diffusion in comparison with LULY™. DSC and XRD studies confirmed that
luliconazole retains its crystalline property in the prepared formulation. Antifungal study against Trichophyton spp. showed that LCZ-NL has comparatively higher growth inhibition than LULY™. Hence, developed LCZ-NL can be a promising topical drug delivery system for treating
onychomycosis.