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

  • Chad Brown
  • James DiNunzio
  • 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
Chapter
First Online:
Part of the Advances in Delivery Science and Technology book series (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.

Keywords

Hot-melt extrusion Amorphous process selection Dispersion formulation Solid-state characterization Mechanical properties Solubility enhancement Melt processing Early development Composition design Enabled formulation 
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Copyright information

© Controlled Release Society 2014

Authors and Affiliations

  • Chad Brown
    • 2
  • James DiNunzio
    • 1
  • Michael Eglesia
    • 2
  • Seth Forster
    • 2
  • Matthew Lamm
    • 2
  • Michael Lowinger
    • 2
  • Patrick Marsac
    • 2
  • Craig McKelvey
    • 2
  • Robert Meyer
    • 2
  • Luke Schenck
    • 2
  • Graciela Terife
    • 2
  • Gregory Troup
    • 2
  • Brandye Smith-Goettler
    • 2
  • Cindy Starbuck
    • 2
  1. 1.Pharmaceutical Sciences & Clinical SuppliesMerck & Co., Inc.SummitUSA
  2. 2.Merck & Co., Inc.Whitehouse StationUSA

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