New therapeutic system based on hydrogels for vaginal candidiasis management: formulation–characterization and in vitro evaluation based on vaginal irritation and direct contact test

Abstract

The objective of the present research was to examine the possible usage of terbinafine loaded hydrogels for vaginal application as part of vaginal candidiasis treatment. Vaginal candidiasis belongs to the most frequent gynecological disorders. Various antifungal drugs are used for its treatment, with Terbinafine being one of them. In this study, new gel formulations were prepared for Terbinafine vaginal delivery. Natural polymers such as chitosan, sodium carboxymethylcellulose, and Carbopol were used for the development of Terbinafine vaginal gels. The developed gels were examined for their viscosity and spreadability, pH and mechanical properties. The most optimal formulations were further evaluated for their in vitro release behavior and antifungal activities. In further, the cytotoxicity and irritation inducing capacity of optimum gel formulations were evaluated. In vitro drug release studies demonstrated that terbinafine release was prolonged whereas anti-candida activity in several species showed the superiority of the gels compared to the marketed product. G-5 and G-8 gels did not cause lysis, hemorrhage and coagulation, therefore, classified as non-irritant. The optimal formulations were also studied for their stability, demonstrating that they were stable for 3 months.

Keywords:

• Vaginal delivery
• terbinafine
• hydrogels
• HET-CAM
• chitosan
• Carbopol
• sodium carboxymethylcellulose

Acknowledgments

The authors wish to thank the Amino Chemicals Limited, Malta, for providing Terbinafine hydrochloride. The authors wish to thank Primex, Iceland for the kind gift the Chitosan. The authors are grateful to Dr Panoraia Siafaka for FTIR studies.

Disclosure statement

The authors declare no conflict of interest.