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Process monitoring and visualization solutions for hot-melt extrusion: a review

Lien Saerens (UGent) , Chris Vervaet (UGent) , Jean Paul Remon (UGent) and Thomas De Beer (UGent)
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Abstract
Objectives: Hot-melt extrusion (HME) is applied as a continuous pharmaceutical manufacturing process for the production of a variety of dosage forms and formulations. To ensure the continuity of this process, the quality of the extrudates must be assessed continuously during manufacturing. The objective of this review is to provide an overview and evaluation of the available process analytical techniques which can be applied in hot-melt extrusion. Key Findings: Pharmaceutical extruders are equipped with traditional (univariate) process monitoring tools, observing barrel and die temperatures, throughput, screw speed, torque, drive amperage, melt pressure and melt temperature. The relevance of several spectroscopic process analytical techniques for monitoring and control of pharmaceutical HME has been explored recently. Nevertheless, many other sensors visualizing HME and measuring diverse critical product and process parameters with potential use in pharmaceutical extrusion are available, and were thoroughly studied in polymer extrusion. The implementation of process analytical tools in HME serves two purposes: (1) improving process understanding by monitoring and visualizing the material behaviour and (2) monitoring and analysing critical product and process parameters for process control, allowing to maintain a desired process state and guaranteeing the quality of the end product. Summary: This review is the first to provide an evaluation of the process analytical tools applied for pharmaceutical HME monitoring and control, and discusses techniques that have been used in polymer extrusion having potential for monitoring and control of pharmaceutical HME.
Keywords
NEAR-INFRARED SPECTROSCOPY, process understanding, process analysis, hot-melt extrusion, in-process monitoring, TWIN-SCREW EXTRUDER, RESIDENCE TIME DISTRIBUTION, ONLINE ROTATIONAL RHEOMETRY, SOLID LIPID EXTRUSION, WATER-SOLUBLE DRUGS, IN-LINE, RAMAN-SPECTROSCOPY, PHARMACEUTICAL APPLICATIONS, POLYMER MELTS

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Citation

Please use this url to cite or link to this publication:

Chicago
Saerens, Lien, Chris Vervaet, Jean Paul Remon, and Thomas De Beer. 2014. “Process Monitoring and Visualization Solutions for Hot-melt Extrusion: a Review.” Journal of Pharmacy and Pharmacology 66 (2): 180–203.
APA
Saerens, L., Vervaet, C., Remon, J. P., & De Beer, T. (2014). Process monitoring and visualization solutions for hot-melt extrusion: a review. JOURNAL OF PHARMACY AND PHARMACOLOGY, 66(2), 180–203.
Vancouver
1.
Saerens L, Vervaet C, Remon JP, De Beer T. Process monitoring and visualization solutions for hot-melt extrusion: a review. JOURNAL OF PHARMACY AND PHARMACOLOGY. 2014;66(2):180–203.
MLA
Saerens, Lien, Chris Vervaet, Jean Paul Remon, et al. “Process Monitoring and Visualization Solutions for Hot-melt Extrusion: a Review.” JOURNAL OF PHARMACY AND PHARMACOLOGY 66.2 (2014): 180–203. Print.
@article{4270305,
  abstract     = {Objectives: Hot-melt extrusion (HME) is applied as a continuous pharmaceutical manufacturing process for the production of a variety of dosage forms and formulations. To ensure the continuity of this process, the quality of the extrudates must be assessed continuously during manufacturing. The objective of this review is to provide an overview and evaluation of the available process analytical techniques which can be applied in hot-melt extrusion.
Key Findings: Pharmaceutical extruders are equipped with traditional (univariate) process monitoring tools, observing barrel and die temperatures, throughput, screw speed, torque, drive amperage, melt pressure and melt temperature. The relevance of several spectroscopic process analytical techniques for monitoring and control of pharmaceutical HME has been explored recently. Nevertheless, many other sensors visualizing HME and measuring diverse critical product and process parameters with potential use in pharmaceutical extrusion are available, and were thoroughly studied in polymer extrusion. The implementation of process analytical tools in HME serves two purposes: (1) improving process understanding by monitoring and visualizing the material behaviour and (2) monitoring and analysing critical product and process parameters for process control, allowing to maintain a desired process state and guaranteeing the quality of the end product.
Summary: This review is the first to provide an evaluation of the process analytical tools applied for pharmaceutical HME monitoring and control, and discusses techniques that have been used in polymer extrusion having potential for monitoring and control of pharmaceutical HME.},
  author       = {Saerens, Lien and Vervaet, Chris and Remon, Jean Paul and De Beer, Thomas},
  issn         = {0022-3573},
  journal      = {JOURNAL OF PHARMACY AND PHARMACOLOGY},
  keyword      = {NEAR-INFRARED SPECTROSCOPY,process understanding,process analysis,hot-melt extrusion,in-process monitoring,TWIN-SCREW EXTRUDER,RESIDENCE TIME DISTRIBUTION,ONLINE ROTATIONAL RHEOMETRY,SOLID LIPID EXTRUSION,WATER-SOLUBLE DRUGS,IN-LINE,RAMAN-SPECTROSCOPY,PHARMACEUTICAL APPLICATIONS,POLYMER MELTS},
  language     = {eng},
  number       = {2},
  pages        = {180--203},
  title        = {Process monitoring and visualization solutions for hot-melt extrusion: a review},
  url          = {http://dx.doi.org/10.1111/jphp.12123},
  volume       = {66},
  year         = {2014},
}

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