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Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution

The granule size distribution is a critical quality attribute of granules. It has a great impact on further packaging or processing. Due to increasing interest in continuous manufacturing techniques, it is of high interest to develop an in-line or on-line tool to monitor the granule size distributio...

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Detalles Bibliográficos
Autores principales: Wilms, Annika, Knop, Klaus, Kleinebudde, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733292/
https://www.ncbi.nlm.nih.gov/pubmed/31517294
http://dx.doi.org/10.1016/j.ijpx.2019.100029
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author Wilms, Annika
Knop, Klaus
Kleinebudde, Peter
author_facet Wilms, Annika
Knop, Klaus
Kleinebudde, Peter
author_sort Wilms, Annika
collection PubMed
description The granule size distribution is a critical quality attribute of granules. It has a great impact on further packaging or processing. Due to increasing interest in continuous manufacturing techniques, it is of high interest to develop an in-line or on-line tool to monitor the granule size distribution. However, development of an in-line measurement tool for granule size distribution was challenging since large throughput and inhomogeneous product stream are limiting factors for current particle size analyzers. In this study, continuous sampling was tested in conjunction to a continuous on-line method of size determination using dynamic image analysis. A rotating tube sample divider was used to split previously compacted material in representative samples at different ratios and the sample was directly conveyed to the particle size analyzer where the granule size distribution was determined. The method was tested for different granule sizes to determine limits of detection and its ability to detect these changes immediately, as this enables real-time monitoring of the process. This research is the base for development of control tools concerning the granule size distributions for continuous granulation processes.
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spelling pubmed-67332922019-09-12 Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution Wilms, Annika Knop, Klaus Kleinebudde, Peter Int J Pharm X Article The granule size distribution is a critical quality attribute of granules. It has a great impact on further packaging or processing. Due to increasing interest in continuous manufacturing techniques, it is of high interest to develop an in-line or on-line tool to monitor the granule size distribution. However, development of an in-line measurement tool for granule size distribution was challenging since large throughput and inhomogeneous product stream are limiting factors for current particle size analyzers. In this study, continuous sampling was tested in conjunction to a continuous on-line method of size determination using dynamic image analysis. A rotating tube sample divider was used to split previously compacted material in representative samples at different ratios and the sample was directly conveyed to the particle size analyzer where the granule size distribution was determined. The method was tested for different granule sizes to determine limits of detection and its ability to detect these changes immediately, as this enables real-time monitoring of the process. This research is the base for development of control tools concerning the granule size distributions for continuous granulation processes. Elsevier 2019-08-12 /pmc/articles/PMC6733292/ /pubmed/31517294 http://dx.doi.org/10.1016/j.ijpx.2019.100029 Text en © 2019 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Wilms, Annika
Knop, Klaus
Kleinebudde, Peter
Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title_full Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title_fullStr Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title_full_unstemmed Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title_short Combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
title_sort combination of a rotating tube sample divider and dynamic image analysis for continuous on-line determination of granule size distribution
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733292/
https://www.ncbi.nlm.nih.gov/pubmed/31517294
http://dx.doi.org/10.1016/j.ijpx.2019.100029
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