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Abstract  

Modern thermal analysis, microcalorimetry and new emerging combined techniques which deliver calorimetric, microscopic and spectroscopic data offer a powerful analytical battery for the study of pharmaceuticals. These techniques are very useful in all steps of development of new drug products as well as methods for quality control in production. The characterization of raw materials enables to understand the relationships between polymorphs, solvates and hydrates and to choose the proper development of new drug products with very small amount of material in a very short time. Information on stability, purity is valuable for new entities as well as for marketed drug substances from different suppliers. Excipients which vary from single organic or inorganic entity to complexes matrixes or polymers need to be characterized and properly controlled. The thermodynamic phase-diagrams are the basis of the studies of drug-excipients interactions. They are very useful for the development of new delivery systems. A great number of new formulations need proper knowledge of the behaviour of the glass transition temperature of the components. Semi-liquid systems, interactions in aqueous media are also successfully studied by these techniques.

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. Chem Eng Technol . 2006 ; 29 : 233 – 237 10.1002/ceat.200500397 . 9. Snider , DA , Addicks , W , Owens , W . Polymorphism in generic drug product development . Adv Drug Deliv Rev

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. Because the amorphous state is in a higher energy state than the crystalline form, several physical changes can take place, resulting in several solid-state stability problems affecting drug product development, manufacture and shelf life [ 3

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with millions of theoretical plates [32, 33]. Although miniaturization has now been introduced in HPLC, it does not reach the level of the miniaturization and simplicity in CE. Stability testing forms an integral part of drug product development

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