QbD-Driven Development and Characterization of Solid Lipid Nanoparticles (SLNs)-Based Nanogel of Luliconazole for the Effective Management of Dermal Fungal Infection

Purpose Solid lipid nanoparticles (SLNs) have shown tremendous utility in the topical delivery of such anti-fungal moieties. Hence, it was aimed to develop luliconazole (LCZ)-loaded SLN-based topical nanogel for improvised efficacy against topical fungal infections. Methods Response surface methodology-based experimental design, i.e., BBD, was employed to prepare LCZ-SLNs by solvent diffusion method. The SLNs were characterized based on particle size, entrapment efficiency, polydispersity index, zeta potential, and morphological investigations by SEM and transformed into gel form using pH-triggered gelling mechanism. After characterization, pH, viscosity, and texture profile, the developed gel's ex vivo drug release profiles were investigated, followed by ex vivo permeation studies and dermal retention studies. The developed gel was evaluated in vitro for its antifungal potential against Candida albicans and Sporotheix schenckii, safety, and long-term storage stability. Results The results showed the development of spherical shape colloidal nanosize particles (111.33 nm) with no aggregation. The drug entrapment efficiency was 63.65%, and the zeta potential was obtained to be 23.33 +/- 2.5 mV, presenting good stability. LCZ showed prolonged in vitro release from SLNs dispersion and gel. In vitro anti-fungal investigation portrayed a significant reduction in the growth inhibition zone (p < .05) compared to the control group. The findings of the study suggest that the developed LCZ-loaded SLN topical gels are safe to use and have long storage stability. Conclusion In conclusion, SLNs with optimum particle size, high entrapment efficiency, and modified drug release patterns can offer a promising carrier for the topical delivery of luliconazole-like molecules.