ISSN:
1572-8943
Keywords:
amorphous state
;
combined techniques
;
drug design
;
drug product development
;
drug substance
;
drug technology
;
DSC
;
excipients
;
failure investigations
;
hydrates
;
MDSC
;
microcalorimetry
;
pharmaceuticals
;
polymorphism
;
polymers
;
preformulation
;
process optimization
;
purity
;
quality control
;
solvates
;
stability
;
sub-ambient DSC
;
TG
;
temperature resolved X-ray diffraction
;
water interactions
;
thermal microscopy
;
water sorption-desorption
Source:
Springer Online Journal Archives 1860-2000
Topics:
Chemistry and Pharmacology
Notes:
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.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1010194020563
