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D. GironNovartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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M. MutzNovartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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Ph. SchwabNovartis Pharma Chemical and Analytical Research and Development Basel Switzerland

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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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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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Geopolymers

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Author:
J. Davidovits