Design, Optimization, and Chemical Characterization of a Terbinafine Nanosponge-Based Nanogel Using a Factorial Methodological Approach

Terbinafine exhibits poor nail permeability, which limits its effectiveness against onychomycosis. To enhance topical delivery, a terbinafine nanosponge-loaded nanogel (TNG۳-O) has been developed for sustained antifungal action. Pre-formulation studies validated drug purity and compatibility using FTIR and XRD analyses. A ۳² factorial design improved the nanosponge formulation by using Eudragit RS۱۰۰ and PVA. Nanosponges prepared by emulsion solvent diffusion were added to a Carbopol ۹۴۰-based nanogel and tested for their physical and chemical properties, antimicrobial activity, and in vivo activity. The TNG۳-O had a particle size of ۱۷۷.۲ nm, a zeta potential of –۲۵.۷ mV, and a drug loading of ۶۷.۵%. It had a pH of ۵.۷۱, a viscosity of ۳۵,۱۰۰ mPa.s, a spreadability of ۳۶.۵ g.cm/s, and a drug content of ۹۳.۱۲%, and it was stable. SEM confirmed that the nanosponges were spherical and evenly spread. TNG۳-O created inhibition zones of ۲۹ ± ۰.۰۰ mm (Candida albicans) and ۳۰ ± ۰.۰۰ mm (Trichophyton rubrum), which was better than the marketed formulation. In vivo, TNG۳-O significantly diminished fungal invasion and formation of subungual abscesses in infected guinea pigs. TNG۳-O offers a stable and effective topical system with superior antifungal efficacy and is a promising approach for the management of onychomycosis.

کلیدواژه ها:

Terbinafine ، Nanosponge ، Eudragit RS۱۰۰ ، topical antifungal ، Onychomycosis ، Trichophyton rubrum