Formulation and evaluation of mucoadhesive vaginal gel containing novel combination of metronidazole and miconazole nitrate for the treatment of vaginitis

Abstract

Aim of present research work was to develop polycarbophil based mucoadhesive vaginal gel comprising of novel combination of Miconazole nitrate (MIZ) & Metronidazole (MNZ) for the treatment of vaginitis. FT-IR studies revealed no interactions. Gel formulations were characterized for pH, spreadability, viscosity, rheological properties, mucoadhesive force, drug content, in vitro drug release study, drug release kinetics studies & antimicrobial efficacy studies. The pH & spreadability was found to be 4.19 & 5.5 to 8.1 cm, which is compatible with vaginal pH & indicates easy spreadability. F5 & F8 were selected as the best formulations with optimum gel viscosity of 22480 & 24800 cps respectively. The detachment stress of the optimized batch was found to be 81.06 & 88.11 respectively. Drug release was non-diffusion controlled. Microbiological studies revealed faster release of drugs than the commercial markets product of Metronidazole & Miconazole nitrate, expressed as inhibition zone. The stability study as per ICH guidelines revealed that the optimized batch holds promise for a high stability. It can be concluded that formulation batch F5 & F8 was considered optimized since it showed better release pattern of both drugs along with other parameters such as viscosity & mucoadhesive properties.