Abstract
Recurrent vulvovaginal candidiasis is long-term condition that can severely affect the quality of life of affected women. Worldwide, recurrent vulvovaginal candidiasis affects about 138 million women annually (range 103–172 million), with a global annual prevalence of 3871 per 100 000 women; 372 million women are affected by recurrent vulvovaginal candidiasis over their lifetime. Along with oral antifungals, intravaginal therapy represents the route of choice for both local and systemic effects, which is patient convenient and effective alternate for vaginal infections. Mucoadhesive vaginal films of itraconazole were formulated and optimized using hydroxypropylmethylcellulose CP 50, Eudragit RS 100, PEG 400 and Soluplus ®, solvent casting technique using hydroxyl propylcellulose and sodium alginate as polymers. Propylene glycol and polyethylene glycol-400 were evaluated as plasticizers. Prepared films were evaluated for weight, thickness, uniformity of weight, disintegration time of films, drug content determination, in vitro drug release studies, mechanical strength and antifungal activity. The films exhibited controlled release over more than 24 hrs. From the study it was concluded that the films containing 25 mg itraconazole exhibited satisfactory swelling, an optimum mechanical strength and promising drug release. The formulation was found to be suitable candidate for the antifungal activity of vaginal films for therapeutic use.