Netsu Sokutei
Online ISSN : 1884-1899
Print ISSN : 0386-2615
ISSN-L : 0386-2615
JSCTA Award 2010
Application of Thermal Analysis to the Pharmaceutical Development
Katsuhide Terada
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2011 Volume 38 Issue 2 Pages 46-53

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Abstract
The pharmaceutical development challenges various processes from the exploration of potential candidates of API (active pharmaceutical ingredient) to the manufacturing of pharmaceutical products. To ensure the developability of drug candidates, the full understanding of physicochemical characteristics of API is indispensable for the formulation and manufacturing of pharmaceutical product. We have introduced the usefulness of thermal analysis for the evaluation of various physicochemical characteristics of pharmaceuticals from API to pharmaceutical products. In the field of API, such as thermodynamic relative stability of polymorphs, quantitative relationship between dissolution rate and morphology, and crystallization mechanism of amorphous to polymorphs were studied. In the field of pharmaceutical products, such as compatibility of formulation, evaluation of stability of pharmaceuticals, monitoring of wetting and disintegration process, physical stability estimation of solid dispersion, optimum manufacturing process for freeze drying product were studied.
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© 2011 The Japan Society of Calorimetry and Thermal Analysis
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