Journal of Thermal Analysis and Calorimetry
Volume/Issue:
Volume 68: Issue 2
Solid State Characterizations of Pharmaceutical Hydrates
Authors:
D. Giron Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Ch. Goldbronn Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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M. Mutz Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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S. Pfeffer Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Ph. Piechon Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Ph. Schwab Novartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Pages:
453–465
Online Publication Date:
03 Nov 2004
Publication Date:
01 May 2002
Article Category:
Research Article
DOI:
https://doi.org/10.1023/a:1016031517430
Keywords:
aging; DSC; freezable water; phase changes; phase transitions; pseudo-polymorphism; stability; sub-ambient DSC; TG; TG-MS; water activity
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Abstract  

Manufacturing processes may involve the presence of water in the crystallization of the drug substance or in manufacturing or in the composition of the drug product through excipients. Dehydration steps may occur in drying, milling, mixing and tabletting processes. Furthermore, drug substances and drug products are submitted to different temperatures and relative humidities, due to various climatic conditions giving rise to unexpected hydration or dehydration aging phenomena. Therefore the manufacture and the characterization of hydrates is part of the study of the physical properties of drug substances. Several hydrates and even polymorphic forms thereof can be encountered. Upon dehydration crystal hydrates may retain more or less their original crystal structure, they can lose crystallinity and give anamorphous phase, they can transform to crystalline less hydrated forms or to crystalline anhydrous forms. The proper understanding of the complex polyphasic systemhydrates–polymorphs–amorphous state needs several analytical methods. The use of techniques such as DSC-TG, TG-MS, sorption-desorption isotherms, sub-ambient experiments, X-ray diffraction combined with temperature or moisture changes as well as crystal structure and crystal modelling in addition to solubilities and dissolution experiments make interpretation and quantitation easier as demonstrated with some typical examples.

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Cover Journal of Thermal Analysis and Calorimetry
Journal of Thermal Analysis and Calorimetry
Print ISSN:
1388-6150
Online ISSN:
1572-8943

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation		 1969
Volumes
per Year		 1
Issues
per Year		 24
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)

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