Applications of Thermal Analysis and Coupled Techniques in Pharmaceutical Industry |
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Authors: | Giron D |
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Institution: | (1) Chemical and Analytical Research and Development, Novartis Pharma, Basel, Switzerland |
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Abstract: | Thermal analysis methods are well-established techniques in research laboratories of pharmaceutical industry. The robustness
and sensitivity of instrumentation, the introduction of automation and of reliable software according to the industrial needs
widened considerably the areas of applications in the last decade. Calibration of instruments and validation of results follow
the state of the art of cGMP as for other analytical techniques. Thermal analysis techniques are especially useful for the
study of the behavior of the poly-phasic systems drug substances and excipients and find a unique place for new delivery systems.
Since change of temperature and moisture occur by processing and storage, changes of the solid state may have a considerable
effect on activity, toxicity and stability of compounds. Current requirements of the International Conference of Harmonisation
for the characterization and the quantitation of polymorphism in new entities re-enforce the position of thermal analysis
techniques. This challenging task needs the use of complementary methods. Combined techniques and microcalorimetry demonstrate
their advantages. This article reviews the current use of thermal analysis and combined techniques in research and development
and in production. The advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.
This revised version was published online in August 2006 with corrections to the Cover Date. |
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Keywords: | amorphous state cGMP DSC-TG DSC-X-ray diffraction ICH ICHQ6 microcalorimetry pharmaceutical industry pharmaceuticalpolymers phase transitions phase-diagrams polymorphism sorption-desorption pseudo-polymorphism purity analysis TG-FT-IR TG-MS thermal analysis coupled techniques validation of methods |
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