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生物制品与产品包装的相互作用及克服这些相互作用的潜在方法。

Interactions Between Biological Products and Product Packaging and Potential Approaches to Overcome Them.

机构信息

Department of Pharmaceutics & Drug Delivery, The University of Mississippi, University, Mississippi, 38677, USA.

出版信息

AAPS PharmSciTech. 2018 Nov;19(8):3681-3686. doi: 10.1208/s12249-018-1184-z. Epub 2018 Oct 2.

DOI:10.1208/s12249-018-1184-z
PMID:30280349
Abstract

Biological products such as protein-based biopharmaceuticals are playing an important role in the healthcare and pharmaceutical industry. The interaction between biological products and packaging materials has become the focus of many studies since it can reduce the effectiveness of biological products. These interactions are heavily influenced by the surface properties and physicochemical nature of the therapeutic agents and the packaging materials. Therefore, it is critical to understand the interactions between packaging materials and biological products in order to design biocompatible packaging materials and develop approaches to minimize adverse interactions. We describe the interactions that occur when using several common packaging materials, including glass and polymer. We discuss the interaction between these materials and biological products such as blood, blood derivatives, recombinant proteins, monoclonal antibodies, and gene therapeutics. We also summarize approaches for overcoming these interactions. Understanding the interactions between biological materials and packaging materials is critical for the development of novel packaging materials that improve the safety of pharmaceutical products.

摘要

生物制品,如基于蛋白质的生物制药,在医疗保健和制药行业中发挥着重要作用。由于生物制品与包装材料之间的相互作用会降低生物制品的功效,因此,这种相互作用已成为许多研究的重点。这些相互作用受治疗剂和包装材料的表面特性和物理化学性质的强烈影响。因此,为了设计生物相容性包装材料并开发最小化不利相互作用的方法,了解包装材料和生物制品之间的相互作用至关重要。我们描述了使用几种常见包装材料(包括玻璃和聚合物)时发生的相互作用。我们讨论了这些材料与生物制品(如血液、血液衍生物、重组蛋白、单克隆抗体和基因治疗药物)之间的相互作用。我们还总结了克服这些相互作用的方法。了解生物材料和包装材料之间的相互作用对于开发新型包装材料以提高药物产品的安全性至关重要。

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