Saar Sinem, Tuğcu Demiröz Fatmanur
Gazi University Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Türkiye.
Turk J Pharm Sci. 2025 May 14;22(2):71-76. doi: 10.4274/tjps.galenos.2025.48380.
Bacterial vaginosis (BV) is a common disease in women of reproductive age. Metronidazole (MET) is an antibiotic used to treat BV 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.
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 mucoadhesion properties of the films were determined with vaginal tissue. The release of MET from the films was investigated using Franz diffusion cells.
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.
Mucoadhesive films can be used as an alternative dosage form for vaginal delivery of MET in the treatment of BV.
细菌性阴道病（BV）是育龄期女性的常见疾病。甲硝唑（MET）是一种用于经口服或阴道途径治疗BV的抗生素。阴道膜剂是兼具固体和凝胶制剂特性的剂型，可提高患者依从性。本研究旨在开发并表征含MET的阴道膜剂用于治疗BV。
采用溶剂浇铸法，使用聚乙烯醇、羟丙基甲基纤维素K100M以及这些聚合物的混合物制备膜剂。向制剂中添加聚乙二醇400作为增塑剂。检测膜剂的水分含量、平均厚度和重量。此外，用阴道组织测定膜剂的机械性能（拉伸强度和断裂伸长率）和黏膜粘附性能。使用Franz扩散池研究MET从膜剂中的释放情况。
发现制剂的水分含量低于10%。观察到当MET负载到膜剂上时，拉伸强度和断裂伸长率值降低。黏膜粘附值随MET负载量降低，F4、F5和F6的黏膜粘附功值分别为0.070±0.053、0.067±0.039和0.150±0.061。F4、F5和F6的MET释放率分别为92.7%、65.5%和87.6%。
黏膜粘附膜剂可作为MET经阴道给药治疗BV的替代剂型。
