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Structural Characterization of Amorphous Solid Dispersions

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Amorphous Solid Dispersions

Part of the book series: Advances in Delivery Science and Technology ((ADST))

Abstract

Amorphous solid dispersions (ASD) stand on the forefront of solubilizing formulations for many poorly soluble drug candidates. It has been widely accepted that the physical stability, downstream processability, and performance of an ASD largely inherits its physical structure. The in-depth and multi-methodological characterization of ASD microstructure require a range of analytical techniques working on diverse principles. This chapter presents a broad comprehension on various analytical techniques applicable for qualitative and/or quantitative analysis of the physical structure of ASD, e.g., molecular miscibility/mobility, compositional homogeneity, crystallinity, etc. The application, strength, and limitations of calorimetric techniques (differential scanning calorimetry, isothermal microcalorimetry), powder X-ray diffractometry, and gravimetric vapor sorption for the elucidation of various molecular level attributes of ASD are extensively discussed. Furthermore, brief accounts on the use of spectroscopic, microscopic, surface analytical, hyphenated, and some emerging techniques for the assessment of ASD microstructure are summarized.

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Authors and Affiliations

  1. Drug Delivery and Disposition, University of Leuven, Leuven, Belgium

    Amrit Paudel, Joke Meeus & Guy Van den Mooter

  2. Research Center Pharmaceutical Engineering GmbH (RCPE), Graz, Austria

    Amrit Paudel

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  1. Amrit Paudel
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  2. Joke Meeus
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  3. Guy Van den Mooter
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Correspondence to Guy Van den Mooter .

Editor information

Editors and Affiliations

  1. Kashiv Pharmaceuticals, Bridgewater, New Jersey, USA

    Navnit Shah

  2. Merck & Co., Inc., Summit, New Jersey, USA

    Harpreet Sandhu

  3. Kashiv Pharmaceuticals, Bridgewater, New Jersey, USA

    Duk Soon Choi

  4. Pharmaceutical Research & Early Development, Roche Innovation Center, New York, New York, USA

    Hitesh Chokshi

  5. Pharmaceutical and Analytical R&D, Hoffmann-La Roche Ltd., Nutley, New Jersey, USA

    A. Waseem Malick

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Paudel, A., Meeus, J., Mooter, G. (2014). Structural Characterization of Amorphous Solid Dispersions. In: Shah, N., Sandhu, H., Choi, D., Chokshi, H., Malick, A. (eds) Amorphous Solid Dispersions. Advances in Delivery Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1598-9_14

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