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Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process

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Melt Extrusion

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 9))

Abstract

The implementation of continuous manufacturing in the pharmaceutical industry has been of increasing interest over the last years. This chapter focuses on continuous hot melt extrusion (HME) processing as well as on the continuous downstream options that are available. Furthermore, process analytical technology (PAT) tools and the integration of such tools in process control environment are presented. In general, real-time pharmaceutical process verification is accomplished by monitoring univariate (temperature, pressure, etc.) and multivariate (spectra, images, etc.) process parameters and quality attributes, to provide an accurate state estimation of the process, required for advanced control strategies. This chapter describes the development and use of such tools for a continuous HME process, monitored with generic sensors and a near-infrared (NIR) spectrometer in real time, using SIPAT (Siemens platform to collect, display and extract process information) and additional components developed as needed.

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Authors and Affiliations

  1. Institute for Process Engineering, Pharmaceutical and Process Engineering, Graz University of Technology, Graz, Austria

    Daniel Treffer, Patrick Wahl, Daniel Markl, Gerold Koscher, Eva Roblegg & Johannes G. Khinast

Authors
  1. Daniel Treffer
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  2. Patrick Wahl
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  3. Daniel Markl
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  4. Gerold Koscher
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  5. Eva Roblegg
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  6. Johannes G. Khinast
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Corresponding author

Correspondence to Johannes G. Khinast .

Editor information

Editors and Affiliations

  1. Department of Pharmaceutics, University of Mississippi School of Phar National Center for Natural Products Res, University, Mississippi, USA

    Michael A. Repka

  2. Pharma Ingredients & Services, BASF Corporation, Tarrytown, New York, USA

    Nigel Langley

  3. Bridgewater, New Jersey, USA

    James DiNunzio

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© 2013 American Association of Pharmaceutical Scientists

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Treffer, D., Wahl, P., Markl, D., Koscher, G., Roblegg, E., Khinast, J. (2013). Hot Melt Extrusion as a Continuous Pharmaceutical Manufacturing Process. In: Repka, M., Langley, N., DiNunzio, J. (eds) Melt Extrusion. AAPS Advances in the Pharmaceutical Sciences Series, vol 9. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-8432-5_15

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