阴道给药用甲硝唑黏附膜的研制与表征。

Sinem Saar, Fatmanur Tuğcu Demiröz
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引用次数: 0

摘要

目的:细菌性阴道病(BV)是育龄妇女的常见病。甲硝唑(MET)是一种抗生素,用于通过口服或阴道途径治疗细菌性阴道炎。阴道膜是一种结合固体和凝胶制剂特性的剂型,可以提高患者的依从性。本研究旨在开发和表征阴道膜配方含有MET治疗细菌性阴部炎。材料和方法:以聚乙烯醇、羟丙基甲基纤维素K100M及其混合物为原料,采用溶剂铸造法制备薄膜配方。将聚乙二醇400作为增塑剂添加到配方中。考察了薄膜配方的含水率、平均厚度和重量。同时,用阴道组织测定了膜的力学性能(抗拉强度和断裂伸长率)和体外黏附性能。用Franz扩散池研究了膜中MET的释放。结果:各制剂的水分含量均小于10%。观察到,当MET加载到薄膜上时,拉伸强度和断裂伸长率下降。F4、F5、F6的黏附作用值分别为0.070±0.053、0.067±0.039、0.150±0.061。F4、F5和F6的MET释放量分别为92.7%、65.5%和87.6%。结论:黏附膜可作为阴道给药的替代剂型,用于治疗细菌性阴道炎。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

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