Preparation, In Vitro Evaluation and Ex Vivo Skin Deposition of Fenticonazole Nitrate Niosomal Gel

Objective: This study aimed to formulate and optimise a niosomal gel containing fenticonazole nitrate to improve skin deposition and enhance topical antifungal delivery. Methods: Fifteen niosomal formulations were prepared with varying ratios of Span 60, Span 80, and cholesterol, with or without Tween 60. The formulations were evaluated for particle size, polydispersity index (PDI), zeta potential, entrapment efficiency (EE), and in vitro drug release. The optimised niosomal formulation was incorporated into gels containing varying concentrations of sodium carboxymethyl cellulose (NaCMC). The resulting gels were characterised for physical and rheological properties, in vitro drug-release behaviour, and ex vivo skin deposition using Franz diffusion cells. Results: The optimised niosomal formulation exhibited a particle size of 160.13±1.8 nm, a PDI of 0.16±0.04, a zeta potential of+20 mV, and an EE of 90±2%, indicating a moderately stable vesicular system. In addition, the non-ionic surfactants provide steric stabilization, which further enhances the physical stability of the niosomal vesicles. The niosomal dispersion achieved approximately 92.3% drug release over 8 h. Among the gel formulations, the gel containing 0.5% w/w NaCMC showed the best physical and rheological properties. Incorporating the optimised niosomes into the gel matrix provided a more controlled release profile, extending drug release to 12 h. Ex vivo skin deposition studies showed that the optimised niosomal gel achieved approximately fourfold higher skin deposition than the commercially available fenticonazole nitrate cream (Fenza®). Conclusion: The developed niosomal gel significantly enhanced the dermal deposition and retention of fenticonazole nitrate, thereby providing sustained drug release. The results indicate that the optimised niosomal gel is a promising topical delivery system for improving antifungal therapy.