Formulation and Evaluation of Mucoadhesive Vaginal Films of Ketoconazole

Abstract

Purpose: The aim of the present study was to formulate and evaluate mucoadhesive films containing Ketoconazole (KT) for the treatment of vaginal infections. Method: The vaginal films were made by solvent casting technique with different ratios of chitosan as mucoadhesive polymer. The prepared films were evaluated for their weight uniformity, thickness uniformity, drug content, folding endurance, in vitro diffusion, in vitro mucoadhesion study, in vitro dissolution and accelerated stability studies at 40 o ± 2 o /75% ± 5% for three months. Results: Compatibility studies by FTIR showed that there was no significant interaction between drug and polymer used. The weight of films was found to be between 1.03 g to 2.47 g. The thickness of films ranged between 0.15 mm to 0.32 mm. The drug content was found to be between 80.5% to 93.7% w/w. The folding endurance of films was found to be between 72.6 and 175.66. Mucoadhesive strength of films ranged between 17.45 g to 26.72 g. F4 was selected as the best formulation based on the evaluation studies and it showed zero order release. Conclusion: Based on the in vitro results it was concluded that the mucoadhesive films prepared with chitosan can be used as controlled drug delivery system and frequency of drug administration can be minimized leading to better patient compliance.