Journal ArticleDOI
Applications of thermal analysis and coupled techniques in pharmaceutical industry
TLDR
The current use of thermal analysis and combined techniques in research and development and in production is reviewed and the advantage of commercially coupled techniques to thermogravimetry is emphasized with some examples.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 inthe 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.read more
Citations
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Journal ArticleDOI
Evaluation of radiostability of some steroid derivatives
TL;DR: The effect of ionising radiation (15-100 kGy) on the physico-chemical properties of 6 steroid derivatives in solid state (Hydrocortisone, Hydrocortinone acetate, Prednisolone and Dexamethasone) was studied by differential scanning calorimetry (DSC), differential thermal analysis (DTA), scanning electron microscopy (SEM), UV spectrophotometry, high-performance liquid chromatography (HPLC), X-ray powder diffraction and polarimetry.
Journal ArticleDOI
Similar but Different: The Case of Metoprolol Tartrate and Succinate Salts
Paola Paoli,Patrizia Rossi,Eleonora Macedi,Andrea Ienco,Laura Chelazzi,Gianluca Bartolucci,Bruno Bruni +6 more
TL;DR: In this article, the solid-state structure and behavior of tartrate (MT-o) and succinate (MS-m) metoprolol salts were studied with a combined experimental (X-ray diffraction by both single crystal and microcrystalline powder and differential scanning calorimetry) and modeling approach (molecular dynamics and molecular orbital calculations).
Journal ArticleDOI
Thermal compatibility studies of nitroimidazoles and excipients
Márcia Ferraz Pinto,Elisana Afonso de Moura,Fábio Santos de Souza,Rui Oliveira Macêdo,Rui Oliveira Macêdo +4 more
TL;DR: In this article, a model was developed to characterize possible interactions between active substances and excipients using: Thermogravimetry, Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC), and DSC coupled to photovisual system.
Journal ArticleDOI
Non-isothermal dehydration kinetic study of aspartame hemihydrate using DSC, TGA and DSC-FTIR microspectroscopy.
TL;DR: In this article, three thermal analytical techniques such as differential scanning calorimetry (DSC), thermal gravimetric analysis (TGA) using five heating rates, and DSC-Fourier Transform Infrared microspectroscopy using one heating rate, were used to determine the thermal characteristics and the dehydration process of aspartame (APM) hemihydrate in the solid state.
Journal ArticleDOI
Physical and thermal characterisation of chiral omeprazole sodium salts
TL;DR: The physical and thermal properties of both forms are examined and in highlighting their differences provides an explanation for the potential differences in bioavailability and therapeutic efficacy.
References
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Book
Enantiomers, Racemates, and Resolutions
TL;DR: RACEMATE and their ENANTIOMER CONSTITUENTS Types of Crystalline Racemates Binary Mixtures of Enantiomers Solution Properties as mentioned in this paper.
Journal ArticleDOI
Characteristics and Significance of the Amorphous State in Pharmaceutical Systems
Bruno C. Hancock,George Zografi +1 more
TL;DR: The amorphous state is critical in determining the solid-state physical and chemical properties of many pharmaceutical dosage forms and some of the most common methods that can be used to measure them are described.
Journal ArticleDOI
Solid dispersion of poorly water‐soluble drugs: Early promises, subsequent problems, and recent breakthroughs
TL;DR: Commercial use of solid dispersion systems during the past four decades has been very limited, primarily because of manufacturing difficulties and stability problems, but this has been changing in recent years because of the availability of surface-active and self-emulsifying carriers and the development of technologies to encapsulate solid dispersions directly into hard gelatin capsules as melts.
Book
Polymorphism in Pharmaceutical Solids
TL;DR: Brittain et al. as mentioned in this paper applied the phase rule to the characterisation of polymorphic and solvatomorphic systems, and proposed a computational method to predict polymorphism.
Book ChapterDOI
Crystalline Polymorphism of Organic Compounds
TL;DR: A wide variety of techniques appropriate to the study of organic crystalline polymorphism and pseu-dopolymorphism is then surveyed, ranging from simple crystal density measurement to observation of polymorphic transformations using variable-temperature synchrotron X-ray diffraction methods.