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Thermoanalytical Techniques for the Investigation of the Freeze Drying Process and Freeze-Dried Products

机译:研究冷冻干燥过程和冷冻干燥产品的热分析技术

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摘要

A key challenge facing the pharmaceutical industry is the production of biotechnological drug products such as proteins in a stable form. Freeze-drying is preferred for manufacturing such products because of the low temperatures used. However, the protein may still degrade during the process necessitating the inclusion of a protectant.nnThis review describes the range of thermal analysis techniques that have been used to investigate the properties of formulations to be freeze dried and the resultant products. This approach has allowed insight into the key parameters required for design of formulations and processes that will generate the best possible products.
机译:制药业面临的主要挑战是生产生物技术药物产品,例如稳定形式的蛋白质。由于使用的低温,冷冻干燥对于制造此类产品是优选的。但是,蛋白质在加工过程中仍可能降解,因此需要加入保护剂。nn本综述介绍了一系列热分析技术,这些技术已用于研究要冷冻干燥的制剂和所得产品的性能。这种方法可以洞察将设计出能够产生最佳产品的配方和工艺所需的关键参数。

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