Division of Pharmaceutical Technology, Faculty of Pharmacy, University of Helsinki, P.O. Box 56, 00014 Helsinki, Finland.
AAPS PharmSciTech. 2010 Mar;11(1):46-53. doi: 10.1208/s12249-009-9351-x. Epub 2009 Dec 29.
Drying is one of the standard unit operations in the pharmaceutical industry and it is important to become aware of the circumstances that dominate during the process. The purpose of this study was to test microcapsulated thermochromic pigments as heat indicators in a fluid bed drying process. The indicator powders were manually granulated with alpha-lactose monohydrate resulting in three particle-size groups. Also, pellets were coated with the indicator powders. The granules and pellets were fluidized in fluid bed dryer to observe the progress of the heat flow in the material and to study the heat indicator properties of the indicator materials. A tristimulus colorimeter was used to measure CIELAB color values. Color indicator for heat detection can be utilized to test if the heat-sensitive API would go through physical changes during the pharmaceutical drying process. Both the prepared granules and pellets can be used as heat indicator in fluid bed drying process. The colored heat indicators give an opportunity to learn new aspects of the process at real time and could be exploded, for example, for scaling-up studies.
干燥是制药行业的标准单元操作之一,了解过程中占主导地位的情况非常重要。本研究的目的是测试微胶囊化热致变色颜料作为流化床干燥过程中的热指示剂。指示剂粉末用α-乳糖一水合物手动造粒,得到三个粒度组。此外,还对小球进行了指示剂粉末的包衣。将颗粒和小球在流化床干燥器中流化,以观察物料中热流的进展,并研究指示剂材料的热指示剂性能。使用三刺激比色计测量 CIELAB 颜色值。用于检测热量的颜色指示剂可用于测试热敏 API 是否会在药物干燥过程中发生物理变化。制备的颗粒和小球都可用作流化床干燥过程中的热指示剂。有色热指示剂为实时了解该过程的新方面提供了机会,并且可以用于例如放大研究的爆炸。