Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany.
Eur J Pharm Biopharm. 2013 Oct;85(2):162-9. doi: 10.1016/j.ejpb.2013.05.019. Epub 2013 Jun 7.
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.
迈入新世纪，制药领域的冷冻干燥技术不断发展，稳步扩张。本综述旨在突出该领域的最新进展，同时探讨进一步的挑战。首先，概括了冷冻干燥在扩大的药物应用范围。此外，还讨论了新的配方和新的容器系统，并强调了冷冻步骤的重要性。再者，对“绝不高于玻璃化转变温度进行冷冻干燥”的教条提出质疑，并提供了对新型稳定概念的最新见解。目前，过程分析技术（PAT）和质量源于设计（QbD）是主要关注点，未来可能还需要重新考虑冷冻干燥设备的设计。
