In Vitro Characterization of a Novel Medical Device in Simulated Vaginal Environment |Biomedgrid

Bacterial vaginosis, aerobic vaginitis and candidiasis are the most common infections in women in fertile age, characterized by an imbalanced vaginal microbiota population and vaginal discharge. The therapeutic approach could vary from antibiotics to antiseptics with the risk of developing resistance. For this reason, a novel hydrogel formulation, Fitostimoline® Septagel, has been developed for the local treatment of irritative-inflammatory-dystrophic states of the vaginal area. The aim of this study was to evaluate, by an in vitro assay, the efficacy of Fitostimoline® Septagel on the most common vaginitis and vaginosis pathogen. Agar spot overlay test and the survival of Streptococcus agalactiae, Escherichia coli and Candida albicans pathogens were detected in a simulated vaginal model. Furthermore, to determine the physical properties of Fitostimoline® Septagel, pH, viscosity and the swelling index of the gel were analyzed.