Monitoring Phase Transformations in Intact Tablets of Trehalose by FT-Raman Spectroscopy

被引：15

作者：

Chakravarty, Paroma ^{[1
]}

Bhardwaj, Sunny P. ^{[1
]}

King, Leslie ^{[2
]}

Suryanarayanan, Raj ^{[1
]}

机构：

[1] Univ Minnesota, Dept Pharmaceut, Minneapolis, MN 55455 USA

[2] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46221 USA

来源：

AAPS PHARMSCITECH | 2009年 / 10卷 / 04期

关键词：

phase transformation; Raman spectroscopy; tablet; trehalose; QUANTITATIVE-ANALYSIS; ALPHA; ALPHA-TREHALOSE DIHYDRATE; WET GRANULATION; DEHYDRATION; CRYSTAL; FORMS; TRANSITIONS; POLYMORPHS;

D O I：

10.1208/s12249-009-9337-8

中图分类号：

R9 [药学];

学科分类号：

100702 [药剂学];

摘要：

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 (60A degrees C); 75% RH (25A 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, 60A degrees C), (2) trehalose dihydrate -> alpha-trehalose (0% RH, 60A degrees C), (3) beta-trehalose -> trehalose dihydrate (75% RH, 25A degrees C), and (4) amorphous trehalose -> trehalose dihydrate (75% RH, 25A 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.

引用

页码：1420 / 1426

页数：7

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