Design, Optimization, and Chemical Characterization of a Terbinafine Nanosponge-Based Nanogel Using a Factorial Methodological Approach
نویسندگان
1 GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
2 GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, Andhra Pradesh, India
doi
10.48309/chemm.2026.564156.2062چکیده
Terbinafine exhibits poor nail permeability, which limits its effectiveness against onychomycosis. To enhance topical delivery, a terbinafine nanosponge-loaded nanogel (TNG3-O) has been developed for sustained antifungal action. Pre-formulation studies validated drug purity and compatibility using FTIR and XRD analyses. A 3² factorial design improved the nanosponge formulation by using Eudragit RS100 and PVA. Nanosponges prepared by emulsion solvent diffusion were added to a Carbopol 940-based nanogel and tested for their physical and chemical properties, antimicrobial activity, and in vivo activity. The TNG3-O had a particle size of 177.2 nm, a zeta potential of –25.7 mV, and a drug loading of 67.5%. It had a pH of 5.71, a viscosity of 35,100 mPa.s, a spreadability of 36.5 g.cm/s, and a drug content of 93.12%, and it was stable. SEM confirmed that the nanosponges were spherical and evenly spread. TNG3-O created inhibition zones of 29 ± 0.00 mm (Candida albicans) and 30 ± 0.00 mm (Trichophyton rubrum), which was better than the marketed formulation. In vivo, TNG3-O significantly diminished fungal invasion and formation of subungual abscesses in infected guinea pigs. TNG3-O offers a stable and effective topical system with superior antifungal efficacy and is a promising approach for the management of onychomycosis.