Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen, Erlangen 91058, Germany.
J Pharm Sci. 2012 Nov;101(11):4025-31. doi: 10.1002/jps.23293. Epub 2012 Aug 14.
In the field of freeze-drying, the primary packaging material plays an essential role. Here, the packaging system not only contains and protects the drug product during storage and shipping, but it is also directly involved in the freeze-drying process itself. The heat transfer characteristics of the actual container system influence product temperature and therefore product homogeneity and quality as well as process performance. Consequently, knowledge of the container heat transfer characteristics is of vital importance for process optimization. It is the objective of this review article to provide a summary of research focused on heat transfer characteristics of different container systems for pharmaceutical freeze-drying. Besides the common tubing and molded glass vials and metal trays, more recent packaging solutions like polymer vials, LYOGUARD® trays, syringes, and blister packs are discussed. Recent developments in vial manufacturing are also taken into account.
在冷冻干燥领域，主要包装材料起着至关重要的作用。在这里，包装系统不仅在储存和运输过程中容纳和保护药品，而且直接参与冷冻干燥过程本身。实际容器系统的传热特性会影响产品温度，从而影响产品的均一性和质量以及工艺性能。因此，了解容器的传热特性对于工艺优化至关重要。本文的目的是对不同的药物冷冻干燥用容器系统的传热特性的研究进行综述。除了常见的玻璃管制瓶和金属盘式货架，本文还讨论了最近的包装解决方案，如聚合物瓶、LYOGUARD 托盘、注射器和泡罩包装。本文还考虑了最近在瓶制造方面的发展。
