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Journal ArticleDOI

Applications of thermal analysis and coupled techniques in pharmaceutical industry

D. Giron1
01 May 2002-Journal of Thermal Analysis and Calorimetry (Akadémiai Kiadó, co-published with Springer Science+Business Media B.V., Formerly Kluwer Academic Publishers B.V.)-Vol. 68, Iss: 2, pp 335-357
TL;DR: 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.
Citations
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Journal ArticleDOI
TL;DR: Current understanding of pharmaceutical solids in terms of molecular recognition and complementarity provides new insights into the design and function of single and fully miscible, multiple-component solids with varying degrees of order, and in this way is leading the path to supramolecular pharmaceutics.

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TL;DR: A general prospect of the principal analytical techniques which can be employed for a suitable characterization of drug-cyclodextrin systems in the solid state, evidencing their respective potential advantages and limits is presented.

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TL;DR: The state‐of‐the‐art on this subject is offered in order to develop new insights and to promote cooperative efforts in the fascinating field of API salt and cocrystal forms.

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Cites methods from "Applications of thermal analysis an..."

  • ...This wealth of data is useful to establish manufacturing and storage conditions, and to characterize both solvates and hydrates [102]....

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TL;DR: This article reviews key biophysical aspects and computational studies for several major categories of nanocarriers, including dendrimers and dendrons, polymer-, peptide-, nucleic acid-, lipid-, and carbon-based DDSs, and gold nanoparticles, and discusses how computer modeling can assist in rational design of D DSs with improved and optimized properties.

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Patent
07 Jul 2009
TL;DR: In this article, the present invention is directed to 1,2,5-oxadiazole derivatives, and compositions of the same, which are inhibitors of indoleamine 2,3-dioxygenase and are useful in the treatment of cancer and other disorders.
Abstract: The present invention is directed to 1,2,5-oxadiazole derivatives, and compositions of the same, which are inhibitors of indoleamine 2,3-dioxygenase and are useful in the treatment of cancer and other disorders, and to the processes and intermediates for making such 1,2,5-oxadiazole derivatives.

126 citations

References
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Book
01 Jan 1981
TL;DR: RACEMATE and their ENANTIOMER CONSTITUENTS Types of Crystalline Racemates Binary Mixtures of Enantiomers Solution Properties as mentioned in this paper.
Abstract: RACEMATES AND THEIR ENANTIOMER CONSTITUENTS Types of Crystalline Racemates Binary Mixtures of Enantiomers Solution Properties of Enantiomers and Their Mixtures RESOLUTION OF ENANTIOMER MIXTURES Resolution by Direct Crystallization Formation and Separation of Diastereomers Crystallization-Induced Asymmetric Transformations Experimental Aspects and Art of Resolutions Index

2,028 citations

Journal ArticleDOI
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.

1,864 citations

Journal ArticleDOI
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.

1,730 citations

Book
03 Mar 1999
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.
Abstract: THERMODYNAMIC AND THEORETICAL ISSUES Theory and Principles of Polymorphic Systems, Harry G. Brittain Application of the Phase Rule to the Characterization of Polymorphic and Solvatomorphic Systems, Harry G. Brittain Computational Methodologies: Toward Crystal Structure and Polymorph Prediction, Sarah (Sally) L. Price PREPARATIVE METHODS FOR POLYMORPHS AND SOLVATOMORPHS Classical Methods of Preparation of Polymorphs and Alternative Solid Forms, Peter W. Cains Approaches to High-Throughput Physical Form Screening and Discovery, Alastair J. Florence STRUCTURAL PROPERTIES OF POLYMORPHS AND SOLVATOMORPHS Structural Aspects of Polymorphism, Harry G. Brittain, Stephen R. Byrn, and Eunhee Lee Structural Aspects of Solvatomorphic Systems, Harry G. Brittain, Kenneth R. Morris, and Stephan X. M. Boerrigter Pharmaceutical Co-crystals: A New Opportunity in Pharmaceutical Science for a Long-Known but Little-Studied Class of Compounds, Kapildev K. Arora and Michael J. Zaworotko CHARACTERIZATION METHODS FOR POLYMORPHS AND SOLVATOMORPHS Thermoanalytical and Crystallographic Methods, Sisir Bhattacharya, Harry G. Brittain, and Raj Suryanarayanan Vibrational Spectroscopy, Harry G. Brittain Solid-State Nuclear Magnetic Resonance Spectroscopy, Patrick A. Tishmack Effects of Polymorphism and Solid-State Solvation on Solubility and Dissolution Rate, Harry G. Brittain, David J. R. Grant, and Paul B. Myrdal INTERCONVERSION OF POLYMORPHS AND SOLVATOMORPHS Solid-State Phase Transformations, Harry G. Brittain Effects of Pharmaceutical Processing on the Solid Form of Drug and Excipient Materials, Peter L. D. Wildfong SPECIAL TOPICS RELATED TO POLYMORPHISM AND SOLVATOMORPHISM Structural Aspects of Molecular Dissymmetry, Harry G. Brittain Amorphous Solids, Lynne S. Taylor and Sheri L. Shamblin Index

1,448 citations

Book ChapterDOI
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.
Abstract: Crystal polymorphism is encountered in all areas of research involving solid substances. Its occurrence introduces complications during manufacturing processes and adds another dimension to the complexity of designing materials with specific properties. Research on polymorphism is fraught with unique difficulties due to the subtlety of polymorphic transformations and the inadvertent formation of pseudopolymorphs. In this report, a summary of thermodynamic, kinetic and structural considerations of polymorphism is presented. 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. Application of newer methodology described in this report is yielding fresh insights into the nature of the crystallization process, holding promise for a deeper understanding of the phenomenon of polymorphism and its practical control.

1,444 citations