Formulation and Evaluation of Mucoadhesive Vaginal Film For Vaginal Candidiasis

Abstract

The aim of the present investigation was formulation, optimization and evaluation of mucoadhesive vaginal film of Clotrimazole that could be retained in the vagina for prolonged time for effective treatment of vaginal candidiasis. Clotrimazole is an imidazole derivative antimycotic drug applied locally for the treatment of vaginal candidiasis. Mucoadhesive vaginal films were formulated by solvent casting technique using Hydroxypropyl cellulose -EF (HPC- EF) and Sodium Alginate as polymers. Drug excipient compatibility study was carried out using Fourier Transformed Infrared spectroscopy and Differential Scanning Colorimetry. Propylene glycol and PEG-400 were selected as plasticizer. The vaginal films were evaluated for % elongation, tensile strength, folding endurance, drug content, in-vitro disintegration time, in-vitro dissolution study, swelling index, bioadhesive strength and diffusion study. Amongst various permeation enhancers used, Isopropyl Myristate was selected. To evaluate the role of concentration of permeation enhancer and concentration of polymers in optimization of vaginal film, 32 full factorial design was employed. Optimized batch F3 showed in vitro disintegration time of 18 min, drug content 99.83 % and tensile strength of 502.1 gm/mm2. In-vitro diffusion study showed that 77 % drug diffused in 6 hours. This batch was further evaluated by scanning electron microscopy, indicating that film was uniform. In-vitro lactobacillus inhibition and in-vitro antifungal activity of batch F3 showed inhibitory effect against C. albicans and did not affect the growth of Lactobacillus, which is a normal component of vaginal flora. The optimized formulation was compared with the marketed vaginal tablet and it was concluded that mucoadhesive vaginal film of Clotrimazole is an effective dosage form for treatment of vaginal candidiasis.