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全氟己基辛烷与聚乙烯和聚丙烯药用包装材料的相互作用。

Interactions of Perfluorohexyloctane With Polyethylene and Polypropylene Pharmaceutical Packaging Materials.

机构信息

Biomedical Science, Faculty of Health and Society, Malmö University, SE-205 06 Malmö, Sweden; Biofilms - Research Center for Biointerfaces, Malmö University, SE-205 06 Malmö, Sweden.

Anthony Pettigrew Associates Ltd, Liverpool, UK.

出版信息

J Pharm Sci. 2020 Jul;109(7):2180-2188. doi: 10.1016/j.xphs.2020.03.026. Epub 2020 Mar 30.

DOI:10.1016/j.xphs.2020.03.026
PMID:32240694
Abstract

Semifluorinated alkanes (SFAs) are aprotic solvents, which may be used as drug solvents for topical ocular applications, for instance, in dry eye syndrome. Their physical properties suggest that they might be prone to interaction with plastic materials, such as, polyethylene (PE) and polypropylene (PP), which are commonly used as packaging materials for pharmaceutical products. In this study, we investigate interactions of PE and PP with a liquid SFA perfluorohexyloctane (PFHO) using differential scanning calorimetry (DSC), thermogravimetric analysis (TGA) and cross-polarized light microscopy. Binary phase diagrams of PFHO-PE and PFHO-PP systems demonstrating interactions of PFHO with the polymeric materials were constructed based on DSC data. According to this data, PFHO tends to lower the melting temperatures of PE and PP. The equilibrium values of solubilities of the polymers in PFHO and PFHO in the polymers were obtained by extrapolation of melting enthalpy data. Absorption of PFHO by PE and PP materials at ambient conditions after 4 weeks of equilibration was also studied by TGA. From the presented results, it may be concluded that thorough studies of interactions of PE or PP with SFAs are required when these materials are used as packaging components in SFA-based formulations.

摘要

全氟己基辛烷(SFAs)是非质子溶剂,可作为局部眼部应用的药物溶剂,例如在干眼症综合征中。它们的物理性质表明,它们可能容易与塑料材料相互作用,例如聚乙烯(PE)和聚丙烯(PP),它们通常用作药物产品的包装材料。在这项研究中,我们使用差示扫描量热法(DSC)、热重分析(TGA)和偏光显微镜研究了 PE 和 PP 与液体 SFA 全氟己基辛烷(PFHO)的相互作用。根据 DSC 数据构建了 PFHO-PE 和 PFHO-PP 系统的二元相图,表明 PFHO 与聚合物材料相互作用。根据该数据,PFHO 倾向于降低 PE 和 PP 的熔点。通过外推熔融焓数据获得了聚合物在 PFHO 中的平衡溶解度和 PFHO 在聚合物中的溶解度。还通过 TGA 研究了在平衡 4 周后环境条件下 PFHO 被 PE 和 PP 材料吸收的情况。从呈现的结果可以得出结论,当这些材料用作基于 SFA 的制剂的包装组件时,需要对 PE 或 PP 与 SFAs 的相互作用进行彻底研究。

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