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Formulation, Bioavailability, and Manufacturing Process Enhancement: Novel Applications of Melt Extrusion in Enabling Product Development

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Melt Extrusion

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

Abstract

Melt extrusion is increasingly popular in pharmaceutical applications due to a host of benefits it confers. However, due to the technology’s relatively more recent introduction into pharmaceutical processing, challenges in the development of extrusion based formulations/processes as well as the strategies to resolve them may not be as widely understood as the benefits. This chapter illustrates strategies to resolve challenges in the development of extruder-based formulations/processes using case studies on poorly soluble drugs (a) that are thermosensitive, (b) that exhibit high, or (c) low melting points and glass transition temperatures. Additional case studies also illustrate strategies to enable (d) very high drug loads of up to 95 % for highly water-soluble drugs and (e) moisture-sensitive drugs. As these case studies represent a small part of the expanding universe of melt extrusion applications and a ready-to-use solutions that address the challenges become increasingly available, it is fair to expect that twin-screw extrusion will continue to emerge as a powerful technology solution to a number of pharmaceutical formulation/process challenges.

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Acknowledgments

The author wishes to acknowledge several colleagues from Novartis for their experimental support, many discussions, and insights: Al Hollywood, Arun Patel, Jim Kowalski, Madhav Vasanthavada, Vivian Georgousis, Yu Cao, Jennifer Snyder, Marilyn Alvine, Bal Reddy, and Raju Vegesna; and Mike Motto, Colleen Ruegger, Steve Krill, Tony Tong, Ann Comfort, Alan Royce, Abu Serajuddin, and Yatindra Joshi for their support and encouragement.

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Authors and Affiliations

  1. Novartis Pharmaceuticals Corporation, East Hannover, NJ, USA

    Jay P. Lakshman

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  1. Jay P. Lakshman
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Correspondence to Jay P. Lakshman .

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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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Lakshman, J. (2013). Formulation, Bioavailability, and Manufacturing Process Enhancement: Novel Applications of Melt Extrusion in Enabling Product Development. 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_14

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