Development and Characterization of Mucoadhesive Films Containing Metronidazole for Vaginal Drug Delivery.

OBJECTIVES: Bacterial vaginosis (BV) is a common disease in women of reproductive age. Metronidazole (MET) is an antibiotic used to treat BV via the oral or vaginal route. Vaginal films are dosage forms that combine the properties of solid and gel formulations and increase patient compliance. This study aims to develop and characterize vaginal film formulations containing MET for the treatment of BV. MATERIALS AND METHODS: Film formulations were prepared using the solvent casting method with poly(vinyl alcohol), hydroxypropyl methylcellulose K100M, and mixtures of these polymers. Polyethylene glycol 400 was added to the formulations as a plasticizer. The moisture content, average thickness, and weight of the film formulations were examined. Also, the mechanical properties (tensile strength and elongation at break) and ex vivo mucoadhesion properties of the films were determined with vaginal tissue. The release of MET from the films was investigated using Franz diffusion cells. RESULTS: The moisture content of the formulations was found to be less than 10%. It was observed that tensile strength and elongation at break values decreased when MET was loaded onto the films. Mucoadhesion values decreased with MET loading and the work of mucoadhesion values was found to be 0.070±0.053, 0.067±0.039, and 0.150±0.061 for F4, F5, and F6, respectively. The release of MET was found to be 92.7%, 65.5%, and 87.6% for F4, F5, and F6, respectively. CONCLUSION: Mucoadhesive films can be used as an alternative dosage form for vaginal delivery of MET in the treatment of BV.