Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 96, Issue 5, Pages 1366-1379Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.20923
Keywords
Raman spectroscopy; hydrates/solvates; hydration/dehydration; water in solids; relative humidity; physical stability; kinetics; intermolecular interactions
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Theophylline is known to undergo vapor phase induced hydrate-anhydrate pseudopolymorphic transformations, which can affect its bioavailability. In this work, the kinetics of the pseudopolymorphic transitions of theophylline crystals in different storage conditions is studied using a vibrational spectroscopic technique. While the hydration is a single-step process with a half-life time of ca. 5 h, the dehydration occurs through a two-step mechanism. In addition, the phase stability of hydrate-anhydrate systems in different relative humidity (RH) conditions was probed. The critical RH for anhydrous teophylline was found to be at ca. 79%, while the critical RH for dehydration is ca. 30%. (c) 2007 Wiley-Liss, Inc. and the American Pharmacists Association.
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