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Hot-Melt Extrusion for Solid Dispersions: Composition and Design Considerations

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Amorphous Solid Dispersions

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

Abstract

Melt extrusion is a robust and efficient manufacturing platform that can be utilized for the production of amorphous dispersions. The development of these systems requires careful design of both formulation and process under a structured approach to ensure critical quality attributes are achieved and maintained. This chapter discusses specific aspects for selecting the manufacturing platform, developing and characterizing dispersions that are applicable to the compositional definition.

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Authors and Affiliations

  1. Pharmaceutical Sciences & Clinical Supplies, Merck & Co., Inc., 556 Morris Ave, 07901, Summit, NJ, USA

    James DiNunzio

  2. Merck & Co., Inc., Whitehouse Station, NJ, USA

    Chad Brown, Michael Eglesia, Seth Forster, Matthew Lamm, Michael Lowinger, Patrick Marsac, Craig McKelvey, Robert Meyer, Luke Schenck, Graciela Terife, Gregory Troup, Brandye Smith-Goettler & Cindy Starbuck

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  1. Chad Brown
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  2. James DiNunzio
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  3. Michael Eglesia
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Correspondence to James DiNunzio .

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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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Brown, C. et al. (2014). Hot-Melt Extrusion for Solid Dispersions: Composition and Design Considerations. 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_6

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