Journal of Thermal Analysis and Calorimetry
Volume/Issue:
Volume 73: Issue 2
Characterisation of salts of drug substances
Author:
D. Giron Novartis Pharma Group leader CHAD-ARD, Technical R&D Chemical and Analytical Development Basel Switzerland Basel Switzerland

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Pages:
441–457
Online Publication Date:
31 Oct 2004
Publication Date:
01 Aug 2003
Article Category:
Research Article
DOI:
https://doi.org/10.1023/a:1025461625782
Keywords:
phase transitions; pharmaceutical salt form; salt selection; sorption-desorption; characterisation of salts; polymorphism in salt selection; thermal analysis combined techniques; microcalorimetry; thermal analysis; intrinsic dissolution; polymorphism affected properties; salt candidates
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Abstract  

The properties of the solid-state of drug substances are critical factors that determine the choice of an appropriate salt form for the development of the pharmaceutical formulation. The most relevant properties may affect the therapeutic efficacy, toxicity, bioavailability, pharmaceutical processing and stability. The salt form must fulfil the needs of the targeted formulation, be suitable for full-scale production and its solid-state properties maintained batchwise as well as over time. Comparison of the solid-state properties of different salt candidates may be quite complicated if each salt candidate exist as different solid phases: polymorphs, solvates or amorphous forms. Thermal analysis, microcalorimetry and combined techniques, X-ray diffraction, solubility, intrinsic dissolution, sorption-desorption and stability studies are basic techniques for the characterisation of the salt candidates. Some examples show the role of the salt form as well as the polymorphic form in the characteristics of the solid-state. Thermal analysis and combined techniques are efficient for the detection of unexpected phase transitions and for the comparison of the suitability of the salt candidates prepared for salt selection.

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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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