Preparation and evaluation of vaginal suppo-sponges loaded with benzydamine, in-vitro/in-vivo study

Abstract

This study aimed to design a new Benzydamine HCl (BNZ) suppo-sponge for controlled, mucoadhesive dosage form for vaginal candidiasis treatment, offering advantages over traditional creams, ointments, or gels. BNZ-loaded suppo-sponges were fabricated by simple casting / freeze-drying technique utilizing the cross-linking of chitosan (Cs) with vanillin (V). Vaginal suppo-sponges were prepared based on different vanillin cross-linking ratios (V)._n), from 0 to 2%w/w. To best of our knowledge, this is the first study that uses Schiff's base between chitosan and vanillin as a drug delivery system to treat fungal vaginal infections. Schiff's base formation was confirmed by FT-IR. In-vitro appraisal showed acceptable physical and mechanical characteristics. Formulations based on cross-linking of Cs with V showed a more pronounced in-vitro antifungal activity. In-vitro drug release revealed a prolonged release pattern, becoming more noticeable with the higher cross-linked suppo-sponges (22.34% after 8 h). In-vivo testing of CsV₂ suppo-sponge indicated a more pronounced reduction in fungal count than both CsV₀ and Tantum^® Rosa in the first week, with a peak reduction on day 7 and the 10^th and 11^th days of the second week. Conclusively, Chitosan/vanillin suppo-sponges represent a promising delivery system for drugs intended for local treatment of vaginal candidiasis. than both CsV₀ and Tantum^® Rosa in the first week, with a peak reduction on day 7 and the 10^th and 11^th days of the second week. Conclusively, Chitosan/vanillin suppo-sponges represent a promising delivery system for drugs intended for local treatment of vaginal candidiasis.

Keywords:

• Chitosan
• vanillin
• Schiff’s base
• vaginal
• candida
• sponge

Availability of data and materials

Not applicable.

Ethical approval for in vivo animal experiment

All procedures of animal handling were done in accordance with the National Institute of Health Guide for the Care and Use of Laboratory Animals and approved by the Research Ethical Committee of the Faculty of Pharmacy, Pharos University in Alexandria, Egypt (Ethical Committee approval number: 027-2020).

Disclosure statement

All authors declare that they have no conflict of interest.

CRediT author statement

Noha S. El-Salamouni: In-vitro methodology, writing, review, editing; Marwa A. Yakout: In-vitro & in-vivo microbiological methodology, writing; Ragwa M. Farid: Conceptualization, review, and editing; Gihan S. Labib: Writing, reviewing, and editing.

Acknowledgements

Not applicable.