Recent advances and further challenges in lyophilization
Recent advances and further challenges in lyophilization
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DOI：
10.1016/j.ejpb.2013.05.019
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发表时间：
2013-10-01
影响因子：
4.9
通讯作者：
Friess, Wolfgang
中科院分区：
文献类型：
--
作者：
Kasper, Julia Christina;Winter, Gerhard;Friess, Wolfgang
进入新世纪，冷冻干燥在医药领域得到了不断的发展和稳步扩大。这篇综述旨在强调最近的进展，但也讨论了冷冻干燥方面的进一步挑战。首先，总结了以冷冻干燥为基础的药物应用的扩展范围。此外，还讨论了新的配方方面和新的容器系统，并概述了冻结步骤的重要性。此外，还论证了“玻璃化转变温度以上永不冻干”的教条，并对新的稳定化概念提供了新的见解。过程分析技术(PAT)和设计质量(QBD)现在是主要问题，未来冷冻干燥设备的设计也可能不得不重新考虑。(C)2013爱思唯尔B.V.保留所有权利。
While entering a new century, lyophilization in the pharmaceutical field has been subjected to ongoing development and steady expansion. This review aims to highlight recent advances but also to discuss further challenges in lyophilization.At first, the expanded range of pharmaceutical applications based on lyophilization is summarized. Moreover, novel formulation aspects and novel container systems are discussed, and the importance of the freezing step is outlined. Furthermore, the dogma of "never lyophilize above the glass transition temperature" is argued, and recent insights into novel stabilization concepts are provided. Process analytical technology (PAT) and quality by design (QbD) are now leading issues, and the design of the lyophilization equipment also might have to be reconsidered in the future. (C) 2013 Elsevier B.V. All rights reserved.