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<p>We evaluated the pre-clinical efficacy of simvastatin (SVT)-loaded emulgels in an in vivo model of azole-resistant <i>Candida albicans</i> (ATCC 10231)-induced vaginal candidiasis and conducted in vitro biopharmaceutical characterization of the most effective formulation. The efficacy of SVT-loaded emulgels (15, 30, and 60&#xa0;mg/g) was assessed in immunosuppressed Wistar rats with induced candidiasis and compared to commercially available vaginal creams containing clotrimazole (10&#xa0;mg/g) or nystatin (25,000 IU/g). Products were administered once daily for seven days (<i>n</i> = 5 per group). A high-resolution and sensitive HPLC-PDA method was developed and validated to quantify SVT, determine its solubility in the release medium, and evaluate its in vitro release profile and kinetics. The 60&#xa0;mg/g SVT-loaded emulgel achieved a 100% reduction in fungal load after 7 days (<i>p</i> &lt; 0.05). SVT solubility in the release medium was 881 ± 36&#xa0;µg/mL, and its content in the emulgel was 114.95 ± 4.46% m/m. The controlled release kinetics followed Makoid-Banakar’s model, indicating an average release rate of 0.036%/h. Therefore, the 60&#xa0;mg/g SVT-loaded emulgel shows potential as a therapeutic strategy for treating resistant vulvovaginal candidiasis, warranting further clinical studies.</p>

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Innovative simvastatin-loaded emulgel effectively treats vulvovaginal candidiasis: in vivo efficacy and in vitro biopharmaceutical analysis

  • 期刊论文

  • 发表日期：

    2025年8月18日

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  • Maria Eliza Samuel Amorim,
  • Natália de Oliveira Lima Ribeiro,
  • Flávia Carmo Horta Pinto,
  • Pedro Ferreira de Oliveira,
  • Marcus Vinícius Pommini,
  • Mateus Boaventura Siqueira,
  • Zakariyya Muhammad Bello,
  • Rodrigo Luiz Fabri,
  • Marcelo Gonzaga de Freitas,
  • Renê Oliveira do Couto

摘要

We evaluated the pre-clinical efficacy of simvastatin (SVT)-loaded emulgels in an in vivo model of azole-resistant Candida albicans (ATCC 10231)-induced vaginal candidiasis and conducted in vitro biopharmaceutical characterization of the most effective formulation. The efficacy of SVT-loaded emulgels (15, 30, and 60 mg/g) was assessed in immunosuppressed Wistar rats with induced candidiasis and compared to commercially available vaginal creams containing clotrimazole (10 mg/g) or nystatin (25,000 IU/g). Products were administered once daily for seven days (n = 5 per group). A high-resolution and sensitive HPLC-PDA method was developed and validated to quantify SVT, determine its solubility in the release medium, and evaluate its in vitro release profile and kinetics. The 60 mg/g SVT-loaded emulgel achieved a 100% reduction in fungal load after 7 days (p < 0.05). SVT solubility in the release medium was 881 ± 36 µg/mL, and its content in the emulgel was 114.95 ± 4.46% m/m. The controlled release kinetics followed Makoid-Banakar’s model, indicating an average release rate of 0.036%/h. Therefore, the 60 mg/g SVT-loaded emulgel shows potential as a therapeutic strategy for treating resistant vulvovaginal candidiasis, warranting further clinical studies.