Exploration of synergistically engineered invasomes of fluconazole incorporated with safranal against onychomycosis for enhanced transungual delivery.

OBJECTIVE: The preparation of safranal-containing invasomes for fluconazole (FLU-IN) is investigated in the current research work to augment FLU permeation, bioavailability, and solubility via nail for transungual delivery.

METHODS: FLU-IN was prepared utilizing the 'thin-film hydration process', and for optimization, 'Box-Behnken design (BBD)' was employed. Entrapment efficiency (EE), Poly-dispersity index (PDI), in vitro FLU release, vesicle size and zeta potential were used to characterize FLU-INopt. Confocal microscopy (CLSM), nail permeation investigation, and Transmission electron microscopy (TEM) were also carried out for further examination.

RESULTS: The FLU-INopt demonstrated tiny, spherical, sealed-shape vesicles with a vesicle size of 140.3 nm, PDI of 0.1604, in vitro release of 84.32%, and entrapment efficiency of 74.65%. According to the CLSM investigation, the prepared formulation exhibits better FLU penetration over the nail than FLU suspension gel. Compared to the standard fluconazole marketed gel, the anti-fungal investigation showed that the FLU-IN gel has good anti-fungal potential against Trichophyton rubrum, Nakaseomyces glabrata and Candida albicans. Additional research on Wistar albino rats' skin irritancy supports the new FLU-IN formulation's safety for topical treatment.

CONCLUSION: The present study supported the claim that the developed invasomal formulation is a desirable vesicular carrier for FLU transungual delivery for the management of onychomycosis.