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Stability of Amorphous Solid Dispersion

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Amorphous Solid Dispersions

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

Abstract

Amorphous solid dispersion (ASD) has attracted tremendous attention in pharmaceutical development due to its characteristic solubility enhancement, thus positively affecting oral bioavailability of a range of hydrophobic drugs. Nevertheless, being in a metastable state, ASD has the intrinsic tendency of spontaneously reverting to a more stable crystalline state due to both thermodynamic and kinetic driving forces, making it challenging to the successful development of an ASD dosage form. In this chapter, factors that affect the stability of ASD are reviewed and methods of physical and chemical characterization as well as approaches applicable for stability predictions are discussed. Finally, some practical stability programs that are suitable at different stages of pharmaceutical research and development are introduced. The focus of this chapter is on physical stability of ASD with its chemical stability aspect briefly discussed.

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Acknowledgements

The authors would like to express their gratitude to Dr. Quanying Bao at Novartis for useful discussions and her help with the proof reading.

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Authors and Affiliations

  1. Chemical and Pharmaceutical Profiling, Novartis Pharmaceuticals, Shanghai, China

    Xiang Kou

  2. Ipsen Biosciences, Cambridge, MA, USA

    Liping Zhou

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  1. Xiang Kou
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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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Kou, X., Zhou, L. (2014). Stability of Amorphous Solid Dispersion. 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_16

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