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Journal of Pharmacy and Pharmacology
Article . 2014 . Peer-reviewed
License: OUP Standard Publication Reuse
Data sources: Crossref
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Process monitoring and visualization solutions for hot-melt extrusion: a review

Authors: Saerens, Lien; Vervaet, Chris; Remon, Jean Paul; De Beer, Thomas;

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

Abstract

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.

Country
Belgium
Related Organizations
Keywords

Quality Control, NEAR-INFRARED SPECTROSCOPY, Hot Temperature, IN-LINE, Polymers, Chemistry, Pharmaceutical, Drug Compounding, in-process monitoring, WATER-SOLUBLE DRUGS, RAMAN-SPECTROSCOPY, Freezing, Medicine and Health Sciences, Humans, TWIN-SCREW EXTRUDER, PHARMACEUTICAL APPLICATIONS, SOLID LIPID EXTRUSION, Drug Carriers, hot-melt extrusion, RESIDENCE TIME DISTRIBUTION, Solutions, process understanding, process analysis, POLYMER MELTS, ONLINE ROTATIONAL RHEOMETRY

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    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
69
Top 10%
Top 10%
Top 10%
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