Journal
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 157, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.ejps.2020.105621
Keywords
Vaginal gels, Excipients; Formulation; Sodium Bicarbonate; Vulvovaginal Candidosis
Categories
Funding
- Health Sciences Research Center (CICS-UBI) through National Funds by FCT -Foundation for Science and Technology [UIDB/00709/2020]
- FCT [SFRH/BPD/115145/2016, SFRH/BPD/124437/2016]
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The study aimed to develop and characterize sodium bicarbonate gels to treat VVC, with formulation C showing the most effective inhibition of Candida albicans' growth and other VVC etiological agents. Gel C exhibited physicochemical characteristics suitable for short term treatments and was deemed biocompatible, making it suitable for further development.
Vulvovaginal candidosis (VVC), caused mainly by the yeast Candida albicans, is the second most prevalent vaginal infection. It has been found to have a large impact on women's quality of life, self-esteem and routines. The prevalence of recurrent vulvovaginal candidosis (RVVC) remains high so the development of alternative treatments is needed. The main objective of this study was to develop and characterize sodium bicarbonate gels to treat VVC. We described key formulation characteristics and analyzed their influence on in vitro performance evaluations. The potential to inhibit Candida albicans's growth, the pH, osmolality, viscosity and rheological performance in contact with vaginal fluid simulant and the bioadhesion's profile (using a vaginal ex vivo porcine model) were studied for all formulations. Among the formulations, formulation C (5% sodium bicarbonate, 1% carbomer and 94% water) was the most effective in inhibiting the C. albicans' growth. This gel presented the same potential (the same MIC 2.5%) to inhibit other etiological agents of VVC (C. glabrata, C. krusei, C. tropicalis and C. parapsilosis) for all species tested. Additionally, sensorial characteristics of gel C were in accord with users' preferences. This gel exhibited physicochemical characteristics acceptable for short term treatments, suggesting good overall performance for the treatment of VVC. Furthermore, Gel C was biocompatible with the HeLa cell line (MTT assay) and was classified as a non-severe irritant in the HET-CAM assay (irritation score 4 +/- 1). Overall, gel C was deemed the best performing of the set tested, and suitable for further development.
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