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Physical Instability: A Key Problem of Amorphous Drugs

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Amorphous Drugs

Abstract

Physical instability of amorphous APIs is a complex problem and the major limitation which impedes the wider application of amorphous products in a common practice. There is a set of divergent factors which may cause that material under certain conditions will recrystallize losing the benefits resulting from its amorphous form. It is obvious that the successful implementation of amorphous drug is strictly related to the problem how to control its crystallization ability. Therefore, the debate on the stability of amorphous drug is in a large extent identified with the discussion about its crystallization ability. One should realize that dealing with crystallization is an inherent step of each stage of work with amorphous products. Thus, through understanding of API crystallization behavior is an obligatory starting point during the rational design of amorphous drug compositions maintaining stability for the desired period of time.

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Authors and Affiliations

  1. Institute of Physics, University of Silesia, Chorzów, Poland

    Marzena Rams-Baron & Marian Paluch

  2. Chair of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University - Medical College, Kraków, Poland

    Renata Jachowicz & Witold Jamroz

  3. Institute of Solid State Chemistry and Mechanochemistry, Siberian Branch of the Russian Academy of Sciences, Novosibirsk State University, Novosibirsk, Russian Federation

    Elena Boldyreva

  4. AbbVie, North Chicago, USA

    Deliang Zhou

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  1. Marzena Rams-Baron
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  3. Elena Boldyreva
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  5. Witold Jamroz
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Rams-Baron, M., Jachowicz, R., Boldyreva, E., Zhou, D., Jamroz, W., Paluch, M. (2018). Physical Instability: A Key Problem of Amorphous Drugs. In: Amorphous Drugs. Springer, Cham. https://doi.org/10.1007/978-3-319-72002-9_5

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