Hot melt extrusion as a continuous pharmaceutical manufacturing process

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

doi:10.1007/978-1-4614-8432-5_15

Hot melt extrusion as a continuous pharmaceutical manufacturing process

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

Strathclyde Institute Of Pharmacy And Biomedical Sciences

Research output: Chapter in Book/Report/Conference proceeding › Chapter

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.

Original language	English
Title of host publication	Melt Extrusion
Editors	Michael A. Repka, Nigel Langley, James DiNunzio
Place of Publication	New York
Publisher	Springer
Pages	363-396
Number of pages	34
ISBN (Print)	9781461484318, 9781461484325
DOIs	https://doi.org/10.1007/978-1-4614-8432-5_15
Publication status	Published - 11 Oct 2013

Keywords

injection molding
active pharmaceutical ingredient
computerize system
residence time distribution
process control system

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10.1007/978-1-4614-8432-5_15

Cite this

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title = "Hot melt extrusion as a continuous pharmaceutical manufacturing process",

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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author = "Daniel Treffer and Patrick Wahl and Daniel Markl and Gerold Koscher and Eva Roblegg and Khinast, {Johannes G.}",

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T1 - Hot melt extrusion as a continuous pharmaceutical manufacturing process

AU - Treffer, Daniel

AU - Wahl, Patrick

AU - Markl, Daniel

AU - Koscher, Gerold

AU - Roblegg, Eva

AU - Khinast, Johannes G.

PY - 2013/10/11

Y1 - 2013/10/11

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KW - injection molding

KW - active pharmaceutical ingredient

KW - computerize system

KW - residence time distribution

KW - process control system

U2 - 10.1007/978-1-4614-8432-5_15

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A2 - Langley, Nigel

A2 - DiNunzio, James

PB - Springer

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ER -

Hot melt extrusion as a continuous pharmaceutical manufacturing process

Abstract

Keywords

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