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Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion
Even though hot melt extrusion (HME) is a commonly applied process in the pharmaceutical area, determination of the optimal process parameters is demanding. The goal of this study was to find a rational approach for predetermining suitable extrusion parameters, with a focus on material temperature a...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502425/ https://www.ncbi.nlm.nih.gov/pubmed/36145505 http://dx.doi.org/10.3390/pharmaceutics14091757 |
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author | Gottschalk, Tobias Özbay, Cihangir Feuerbach, Tim Thommes, Markus |
author_facet | Gottschalk, Tobias Özbay, Cihangir Feuerbach, Tim Thommes, Markus |
author_sort | Gottschalk, Tobias |
collection | PubMed |
description | Even though hot melt extrusion (HME) is a commonly applied process in the pharmaceutical area, determination of the optimal process parameters is demanding. The goal of this study was to find a rational approach for predetermining suitable extrusion parameters, with a focus on material temperature and throughput. A two-step optimization procedure, called scale-independent optimization strategy (SIOS), was applied and developed further, including the use of an autogenic extrusion mode. Three different polymers (Plasdone S-630, Soluplus, and Eudragit EPO) were considered, and different optimal process parameters were assessed. The maximum barrel load was dependent on the polymers’ bulk density and the extruder size. The melt temperature was influenced by the screw speed and the rheological behavior of the polymer. The melt viscosity depended mainly on the screw speed and was self-adjusted in the autogenic extrusion. A new approach, called SIOS 2.0, was suggested for calculating the extrusion process parameters (screw speed, melt temperature and throughput) based on the material data and a few extrusion experiments. |
format | Online Article Text |
id | pubmed-9502425 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-95024252022-09-24 Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion Gottschalk, Tobias Özbay, Cihangir Feuerbach, Tim Thommes, Markus Pharmaceutics Article Even though hot melt extrusion (HME) is a commonly applied process in the pharmaceutical area, determination of the optimal process parameters is demanding. The goal of this study was to find a rational approach for predetermining suitable extrusion parameters, with a focus on material temperature and throughput. A two-step optimization procedure, called scale-independent optimization strategy (SIOS), was applied and developed further, including the use of an autogenic extrusion mode. Three different polymers (Plasdone S-630, Soluplus, and Eudragit EPO) were considered, and different optimal process parameters were assessed. The maximum barrel load was dependent on the polymers’ bulk density and the extruder size. The melt temperature was influenced by the screw speed and the rheological behavior of the polymer. The melt viscosity depended mainly on the screw speed and was self-adjusted in the autogenic extrusion. A new approach, called SIOS 2.0, was suggested for calculating the extrusion process parameters (screw speed, melt temperature and throughput) based on the material data and a few extrusion experiments. MDPI 2022-08-23 /pmc/articles/PMC9502425/ /pubmed/36145505 http://dx.doi.org/10.3390/pharmaceutics14091757 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Gottschalk, Tobias Özbay, Cihangir Feuerbach, Tim Thommes, Markus Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title | Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title_full | Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title_fullStr | Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title_full_unstemmed | Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title_short | Predicting Throughput and Melt Temperature in Pharmaceutical Hot Melt Extrusion |
title_sort | predicting throughput and melt temperature in pharmaceutical hot melt extrusion |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502425/ https://www.ncbi.nlm.nih.gov/pubmed/36145505 http://dx.doi.org/10.3390/pharmaceutics14091757 |
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