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

• Published in: AAPS PharmSciTech Vol. 10; no. 4; pp. 1420 - 1426
• Main Authors: Chakravarty, Paroma, Bhardwaj, Sunny P., King, Leslie, Suryanarayanan, Raj
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.12.2009
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Crystallization; Pharmacology/Toxicology; Pharmacy; Phase Transition; Research Article; Spectrum Analysis, Raman - methods; Tablets; Trehalose - chemistry; X-Ray Diffraction; tablet; trehalose; Raman spectroscopy; phase transformation
• ISSN: 1530-9932; 1530-9932
• DOI: 10.1208/s12249-009-9337-8

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 (β-trehalose) were prepared. The tablets were exposed to different conditions [11% and 0% RH (60°C); 75% RH (25°C)] and monitored periodically over 96 h using Raman spectroscopy. Within 96 h of storage, the following phase transformations were observed: (1) trehalose dihydrate → β-trehalose (11% RH, 60°C), (2) trehalose dihydrate → α-trehalose (0% RH, 60°C), (3) β-trehalose → trehalose dihydrate (75% RH, 25°C), and (4) amorphous trehalose → trehalose dihydrate (75% RH, 25°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.