Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen, Cauerstrasse, Erlangen, Germany.
Pharm Dev Technol. 2012 Sep-Oct;17(5):541-51. doi: 10.3109/10837450.2012.700937. Epub 2012 Jun 26.
In a previous study, heat transfer coefficients of different 10 mL tubing and molded vials were determined gravimetrically via sublimation tests with pure water. Contrary to "conventional wisdom", only small differences in K(v) values between tubing and molded vials were found in the pressure range relevant for pharmaceutical freeze-drying. In order to investigate the impact of these relatively small differences on the primary drying time of an actual product, freeze-drying experiments with 5% gentamicin sulfate solution as a model system were performed at 68, 100 and 200 mTorr. The primary drying times of the API in recently developed molded (EasyLyo™), tubing (TopLyo™) and polymer vials (TopPac™) were compared. At 68 and 100 mTorr the primary drying time of the drug in the glass vials only differed by 3% to 4%, while the polymer vial took around 9% longer. At 200 mTorr, the API in the EasyLyo™ vials dried approximately 15% faster compared to the other vial types. The present study suggest that molded vials that have been modified in design to have better heat transfer properties can achieve drying times comparable to tubing vials.
在之前的一项研究中，通过使用纯水进行升华试验，对不同的 10mL 管和模制小瓶的传热系数进行了重量法测定。与“传统观念”相反，在与制药冷冻干燥相关的压力范围内，仅发现管和模制小瓶之间的 K(v)值存在较小差异。为了研究这些相对较小的差异对实际产品的主干燥时间的影响，使用 5%硫酸庆大霉素溶液作为模型系统，在 68、100 和 200mTorr 下进行了冷冻干燥实验。比较了最近开发的模制小瓶（EasyLyo™）、管（TopLyo™）和聚合物小瓶（TopPac™）中 API 的主干燥时间。在 68 和 100mTorr 下，玻璃小瓶中药物的主干燥时间仅相差 3%至 4%，而聚合物小瓶的干燥时间则延长了约 9%。在 200mTorr 下，EasyLyo™小瓶中的 API 干燥速度比其他小瓶类型快约 15%。本研究表明，经过设计改进以具有更好传热性能的模制小瓶可以实现与管小瓶相当的干燥时间。
