Formulation and Characterization of Vaginal Film Containing Clotrimazole

Abstract

Vaginal candidiasis is one of the most common disease faced by women. It is an acute inflammatory disease and a very common reason for gynecological consultation as it can affect up to 75% of women of child-bearing age. This infection is caused by overgrowth of fungi Candida albicans. The conventional products like cream, gels, and ointment does not maintain the required drug concentration for a prolonged period of time and generally get removed by continuous fluid discharge from vagina. Mucoadhesive vaginal drug delivery system such as film provide higher residence time and convenience. Clotrimazole is an antimycotic BCS class II drug having an imidazole ring which is effective for the treatment of vaginal candidiasis. The aim of the current investigation is to formulate and optimize vaginal films containing Clotrimazole and improve its solubility. Film forming polymers like sodium alginate, chitosan were used and solubility enhancement was carried out by preparing inclusion complex of clotrimazole with ß-cyclodextrin. Optimized concentration of permeation enhancers DMSO was used for improving drug diffusion. Various evaluation parameters such as tensile strength ,% elongation, invitro diffusion, swelling index, in-vitro disintegration time were opted for evaluation of the film. Comparative invitro release of optimized film and marketed formulation Candid gel was carried out.