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<p>Vulvovaginal candidiasis (VVC) is a prevalent fungal infection with high recurrence, antifungal resistance, and poor patient compliance. Terbinafine’s antifungal activity is enhanced by tea tree, neem, and citronella oils, which disrupt fungal membranes, inhibit biofilms, and reduce inflammation. Incorporating these oils into a nanoemulsion improves penetration, sustains release, and enhances efficacy. However, terbinafine hydrochloride’s poor solubility and bioavailability limit its therapeutic potential. This study aimed to develop a terbinafine hydrochloride-loaded nanoemulsion gel for VVC treatment using natural antifungal oils and a Quality by Design (QbD) approach.&#xa0;A QbD-based strategy was used to formulate and optimize a stable nanoemulsion gel with enhanced solubility, controlled release, and improved bioavailability. Spontaneous emulsification was followed by optimization using a Central Composite Rotatable Design (CCRD)-based Design of Experiments (DoE).&#xa0;The optimized 1% terbinafine nanoemulsion gel exhibited a droplet size of 7.72 ± 3.04&#xa0;nm, PDI of 0.259, and transmittance of 93.13 ± 4.28%, indicating small, uniform droplets and high clarity. Ex vivo permeation studies demonstrated nearly twice the drug penetration compared to a commercial cream over 8&#xa0;h. Confocal laser scanning microscopy revealed 30% deeper penetration (80&#xa0;μm) in the nanoemulsion gel compared to the marketed formulation (60&#xa0;μm). Histopathological analysis confirmed biocompatibility and safety. The QbD-optimized terbinafine nanoemulsion gel, developed using a CCRD model, demonstrated superior drug penetration, antifungal efficacy, and skin retention, offering a promising topical therapy for VVC.</p> Graphical Abstract <p></p>

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Qbd Engineered and Terpene-Rich Nanoemulgel of Terbinafine for Enhanced Antifungal Efficacy in the Treatment of Vaginal Candidiasis

  • 期刊论文

  • 发表日期：

    2026年1月16日

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  • Naman Batra,
  • Saurabh Mittal,
  • Shivam Pathak,
  • Rupali Verma,
  • Sushama Talegaonkar

摘要

Vulvovaginal candidiasis (VVC) is a prevalent fungal infection with high recurrence, antifungal resistance, and poor patient compliance. Terbinafine’s antifungal activity is enhanced by tea tree, neem, and citronella oils, which disrupt fungal membranes, inhibit biofilms, and reduce inflammation. Incorporating these oils into a nanoemulsion improves penetration, sustains release, and enhances efficacy. However, terbinafine hydrochloride’s poor solubility and bioavailability limit its therapeutic potential. This study aimed to develop a terbinafine hydrochloride-loaded nanoemulsion gel for VVC treatment using natural antifungal oils and a Quality by Design (QbD) approach. A QbD-based strategy was used to formulate and optimize a stable nanoemulsion gel with enhanced solubility, controlled release, and improved bioavailability. Spontaneous emulsification was followed by optimization using a Central Composite Rotatable Design (CCRD)-based Design of Experiments (DoE). The optimized 1% terbinafine nanoemulsion gel exhibited a droplet size of 7.72 ± 3.04 nm, PDI of 0.259, and transmittance of 93.13 ± 4.28%, indicating small, uniform droplets and high clarity. Ex vivo permeation studies demonstrated nearly twice the drug penetration compared to a commercial cream over 8 h. Confocal laser scanning microscopy revealed 30% deeper penetration (80 μm) in the nanoemulsion gel compared to the marketed formulation (60 μm). Histopathological analysis confirmed biocompatibility and safety. The QbD-optimized terbinafine nanoemulsion gel, developed using a CCRD model, demonstrated superior drug penetration, antifungal efficacy, and skin retention, offering a promising topical therapy for VVC.

Graphical Abstract