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Theoretical Considerations in Developing Amorphous Solid Dispersions

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Amorphous Solid Dispersions

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

Abstract

Before pursuing the laborious route of amorphous solid dispersion formulation and development, which is the topic of many of the subsequent chapters in this book, the formulation scientist would benefit from a priori knowledge whether the amorphous route is a viable one for a given drug and how much solubility improvement, and hence increase in bioavailability, can be expected, and what forms of solid dispersion have been developed in the past. In this chapter, we therefore initially define the various forms of solid dispersions, and then go on to discuss properties of pure drugs with respect to their glass-forming ability and glass stability. In the main parts of this chapter, we review theoretical approaches to determine amorphous drug polymer miscibility and crystalline drug polymer solubility, as a prerequisite to develop amorphous solid dispersions (glass solutions).

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Authors and Affiliations

  1. School of Pharmacy, University of Eastern Finland, Kuopio, Finland

    Riikka Laitinen

  2. School of Pharmacy, University of Otago, Dunedin, New Zealand

    Petra A. Priemel

  3. Division of Pharmaceutical Chemistry and Technology, University of Helsinki, Helsinki, Finland

    Sachin Surwase & Clare J. Strachan

  4. pRED, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland

    Kirsten Graeser

  5. Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark

    Holger Grohganz

  6. Pharmaceutical Design and Drug Delivery, Faculty of Health and Medical Sciences, Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark

    Thomas Rades

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  1. Riikka Laitinen
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  2. Petra A. Priemel
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  3. Sachin Surwase
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  4. Kirsten Graeser
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  5. Clare J. Strachan
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  6. Holger Grohganz
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  7. Thomas Rades
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Correspondence to Thomas Rades .

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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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Laitinen, R. et al. (2014). Theoretical Considerations in Developing 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_2

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