通过傅里叶变换拉曼光谱监测海藻糖完整片剂中的相转变。
Monitoring phase transformations in intact tablets of trehalose by FT-Raman spectroscopy.
机构信息
Department of Pharmaceutics, University of Minnesota, 9-157 Weaver Densford Hall, 308 Harvard Street SE, Minneapolis, Minnesota, 55455, USA.
出版信息
AAPS PharmSciTech. 2009;10(4):1420-6. doi: 10.1208/s12249-009-9337-8. Epub 2009 Nov 25.
The purpose of this study is to monitor phase transformations in intact trehalose tablets using FT-Raman spectroscopy. Tablets of trehalose dihydrate, amorphous trehalose (obtained by freeze-drying aqueous trehalose solutions), and anhydrous trehalose (beta-trehalose) were prepared. The tablets were exposed to different conditions [11% and 0% RH (60 degrees C); 75% RH (25 degrees C)] and monitored periodically over 96 h using Raman spectroscopy. Within 96 h of storage, the following phase transformations were observed: (1) trehalose dihydrate-->beta-trehalose (11% RH, 60 degrees C), (2) trehalose dihydrate-->alpha-trehalose (0% RH, 60 degrees C), (3) beta-trehalose-->trehalose dihydrate (75% RH, 25 degrees C), and (4) amorphous trehalose-->trehalose dihydrate (75% RH, 25 degrees C). FT-Raman spectroscopy was a useful technique to identify the solid form and monitor multiple-phase transformations in intact trehalose tablets stored at different conditions.
本研究旨在使用傅里叶变换拉曼光谱监测完整海藻糖片剂中的相转变。制备了海藻糖二水合物、无定形海藻糖（通过冷冻干燥含水海藻糖溶液获得）和无水海藻糖（β-海藻糖）的片剂。将片剂暴露于不同条件下[11%和 0%相对湿度（60°C）；75%相对湿度（25°C）]，并在 96 小时内使用拉曼光谱定期监测。在储存 96 小时内，观察到以下相转变：（1）海藻糖二水合物→β-海藻糖（11% RH，60°C），（2）海藻糖二水合物→α-海藻糖（0% RH，60°C），（3）β-海藻糖→海藻糖二水合物（75% RH，25°C），和（4）无定形海藻糖→海藻糖二水合物（75% RH，25°C）。傅里叶变换拉曼光谱是一种有用的技术，可以识别完整的海藻糖片剂在不同条件下储存时的固体形式和监测多种相转变。
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