Spray drying of biopharmaceuticals: Stability and process considerations
Spray drying of biopharmaceuticals: Stability and process considerations
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DOI：
10.1080/03602550600685275
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发表时间：
2006-01-01
影响因子：
3.3
通讯作者：
Maa, Yuh-Fun
中科院分区：
文献类型：
--
作者：
Ameri, Mahmoud;Maa, Yuh-Fun
喷雾干燥代表了一种用于生产具有独特颗粒特性的生物制药制剂的优雅的一步法。然而，治疗/蛋白质/肽的喷雾干燥的全部潜力尚未被充分开发。不愿意将喷雾干燥用于制剂开发可能源于这样的事实，即该方法经常使治疗活性物质经受超过100 ℃的温度，这对于热不稳定的药物是一个问题，因为喷雾干燥主要在并流喷雾干燥器上以单级模式进行。在这篇综述中，我们讨论了喷雾干燥各自的脱水机制和适当的配方策略，可以采取最大限度地减少对生物分子的不利影响。
Spray drying represents an elegant one-step process for producing biopharmaceutical formulations with unique particle characteristics. However, the full potential of spray drying of therapeutic/proteins/peptides has yet to be fully exploited. The reluctance of utilizing spray drying for formulation development may stem from the fact that the process oftentimes subjects the therapeutic actives to temperatures in excess of 100 degrees C, which is a concern for thermally labile drugs as spray drying was performed primarily on co-current spray dryer in a single-stage mode. In this review we discuss the respective dehydration mechanisms of spray drying and the appropriate formulation strategies that can be taken to minimize detrimental effects on biomolecules.