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<p>Oxiconazole nitrate (OXN) is an imidazole-derived antifungal agent used topically for the treatment of superficial fungal infections, particularly those caused by <i>Candida</i> species and dermatophytes. In this study, a novel hydrogel formulation containing OXN, a choline chloride: propylene glycol (CC: PG)–based green solvent, and poloxamer 407 was developed and extensively characterized as a multifunctional topical delivery system. The formulation was evaluated for thermoresponsive viscosity behavior, drug release, cytocompatibility, antifungal efficacy, and anti-inflammatory activity. Viscosity analysis revealed that, contrary to conventional poloxamer gels, the formulation exhibited a decrease in viscosity with increasing temperature, which may be attributed to a green solvent-mediated suppression of micelle formation. This behavior allowed the hydrogel to remain semi-solid at room temperature while becoming more spreadable at body temperature. In vitro release studies demonstrated that the OXN-loaded hydrogel released 90.98 ± 7.52% of OXN within 24&#xa0;h, significantly higher than the marketed cream formulation (25.74 ± 4.00%). MTT assays confirmed high cell viability (133.65 ± 1.54% in HEK293 and 89.35 ± 1.97% in HaCaT cells), indicating excellent biocompatibility and an increase in metabolic activity that may be associated with the green solvent. Antifungal testing showed enhanced inhibition zones against <i>Candida albicans</i> and <i>Candida glabrata</i>, with minimal activity against <i>Lactobacillus crispatus</i>, suggesting possible microbiota-sparing properties. Furthermore, the hydrogel significantly reduced LPS-induced TNF-α and IL-1β expression by 71.5% and 42.3%, respectively, in RAW 264.7 macrophages. These findings support the potential of the developed OXN-loaded hydrogel (P4-P21) as an effective, biocompatible, anti-inflammatory, and microbiota-sparing topical formulation for the treatment of fungal infections.</p>

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A Multifunctional Green Solvent–poloxamer Hydrogel for Enhanced Topical Oxiconazole Delivery

  • 期刊论文

  • 发表日期：

    2025年11月22日

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  • Muhammet Davut Arpa,
  • Sevde Nur Biltekin Kaleli,
  • Melike Zeynep Ünükür Sevim,
  • Sema Nur Altındaş,
  • Feyza Koçak,
  • Ecem Kartal

摘要

Oxiconazole nitrate (OXN) is an imidazole-derived antifungal agent used topically for the treatment of superficial fungal infections, particularly those caused by Candida species and dermatophytes. In this study, a novel hydrogel formulation containing OXN, a choline chloride: propylene glycol (CC: PG)–based green solvent, and poloxamer 407 was developed and extensively characterized as a multifunctional topical delivery system. The formulation was evaluated for thermoresponsive viscosity behavior, drug release, cytocompatibility, antifungal efficacy, and anti-inflammatory activity. Viscosity analysis revealed that, contrary to conventional poloxamer gels, the formulation exhibited a decrease in viscosity with increasing temperature, which may be attributed to a green solvent-mediated suppression of micelle formation. This behavior allowed the hydrogel to remain semi-solid at room temperature while becoming more spreadable at body temperature. In vitro release studies demonstrated that the OXN-loaded hydrogel released 90.98 ± 7.52% of OXN within 24 h, significantly higher than the marketed cream formulation (25.74 ± 4.00%). MTT assays confirmed high cell viability (133.65 ± 1.54% in HEK293 and 89.35 ± 1.97% in HaCaT cells), indicating excellent biocompatibility and an increase in metabolic activity that may be associated with the green solvent. Antifungal testing showed enhanced inhibition zones against Candida albicans and Candida glabrata, with minimal activity against Lactobacillus crispatus, suggesting possible microbiota-sparing properties. Furthermore, the hydrogel significantly reduced LPS-induced TNF-α and IL-1β expression by 71.5% and 42.3%, respectively, in RAW 264.7 macrophages. These findings support the potential of the developed OXN-loaded hydrogel (P4-P21) as an effective, biocompatible, anti-inflammatory, and microbiota-sparing topical formulation for the treatment of fungal infections.