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

Created on 19 Aug 2025

Authors

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

Published in

Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology]. Aug 18, 2025. Epub Aug 18, 2025.

Abstract

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.

PMID:
40824518
Bibliographic data and abstract were imported from PubMed on 19 Aug 2025.

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