Development of Miconazole nitrate Thermosensitive Bioadhesive Vaignal Gel for Vaginal Candidiasis

Purpose: The aim of the present study was to formulate and evaluate miconazole nitrate containing thermosensitive bioadhesive gel for vaginal drug delivery to achieve a better therapeutic efficacy and patient compliance in the treatment for vaginal candidiasis. Method: Here miconazole nitrate (1%) was formulated as a vaginal gel using thermosensitive polymer, pluronic F127 (20%) along with bioadhesive polymers such as carbopol 934, HPMC, SCMC and polycarbophil. The drug polymer compatibility was studied using FTIR. The prepared formulations were evaluated for parameters such as gelation temperature, gelation time, viscosity, bioadhesive strength, gel strength and drug release. Results: Gelation temperatures for various formulations were found in the range of 30-38 oC with gelation time varying from 1-5 min. The developed formulations had optimum viscosity, good bioadhesive strength and hence will have high retention property which is required for convenience at the site of application. Among the prepared formulations, one with the combination of pluronic F127, polycarbophil and carbopol 934 showed optimum gelation temperature, gelation time, viscosity, bioadhesive strength with sustained drug release for 12 hrs. The optimized formulation (F8) showed insignificant change in physical property and drug content when stability testing was carried out at 25oC/60%RH for 3 months. Conclusions: All the performed experiments confirm the applicability of bioadhesive In-situ gels as a novel delivery system for local therapy of vaginal candidiasis.