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首页> 外文期刊>Journal of Applied Polymer Science >Mathematical Modeling of the Extractables Release from Multi-Layered Plastic Films Used in Drug Product Containers
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Mathematical Modeling of the Extractables Release from Multi-Layered Plastic Films Used in Drug Product Containers

机译：药品容器中多层塑料薄膜中可萃取物释放的数学模型

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The release of extractables from multi-layered plastic films such as those used in containers for liquid drug products has been investigated. Targeted extractables were chosen from the film's extractable profile, as elucidated by a controlled extraction study. The total available pool of targeted extractables was ascertained via exhaustive sequential extraction of the film and the film layer responsible for the target extractables was established. This information, along with the film's structure, was used to produce a mathematical migration model for each of these targets. The film was fashioned into pouches, filled with a simulating solvent and the release of the targeted extractables to the pouches' contents was measured. The measured and modeled concentrations were found to be very similar, establishing the model's ability to effectively mimic the experimental system. This result suggests that mathematical modeling, which is widely used in the food industry to assess the safety of food packaging, may be applicable to packaged pharmaceutical products. (C) 2014 Wiley Periodicals, Inc.
机译：已经研究了从多层塑料薄膜（例如用于液体药物产品的容器中使用的薄膜）释放可提取物的方法。如受控提取研究所阐明的那样，从薄膜的可提取谱中选择目标可提取物。通过对薄膜进行详尽的顺序萃取，确定了目标萃取物的总可用池，并确定了负责目标萃取物的薄膜层。这些信息以及胶片的结构被用于为每个目标生成数学迁移模型。将该薄膜制成小袋，用模拟溶剂填充，然后测量目标可萃取物对小袋内容物的释放。发现测得的浓度和模型浓度非常相似，从而建立了模型有效模拟实验系统的能力。该结果表明，在食品工业中广泛用于评估食品包装安全性的数学建模可能适用于包装的药品。 （C）2014威利期刊公司

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