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Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes

Compaction simulators are frequently used in the formulation and process development of tablets, bringing about the advantages of flexibility, low material consumption, and high instrumentation to generate the most possible process understanding. However, their capability of resembling general aspec...

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Detalles Bibliográficos
Autores principales: Wünsch, Isabell, Friesen, Irene, Puckhaber, Daniel, Schlegel, Thomas, Finke, Jan Henrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238235/
https://www.ncbi.nlm.nih.gov/pubmed/32244401
http://dx.doi.org/10.3390/pharmaceutics12040310
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author Wünsch, Isabell
Friesen, Irene
Puckhaber, Daniel
Schlegel, Thomas
Finke, Jan Henrik
author_facet Wünsch, Isabell
Friesen, Irene
Puckhaber, Daniel
Schlegel, Thomas
Finke, Jan Henrik
author_sort Wünsch, Isabell
collection PubMed
description Compaction simulators are frequently used in the formulation and process development of tablets, bringing about the advantages of flexibility, low material consumption, and high instrumentation to generate the most possible process understanding. However, their capability of resembling general aspects of rotary press compaction and their precision in simulating or mimicking sub-processes such as feeding and filling need to be systematically studied. The effect of material deformation behavior, blend composition, and feeding on tensile strength and simulation precision as compared with rotary presses of different scales is evaluated in this study. Generally, good simulation performance was found for the studied compaction simulator. Compaction profile-sensitivity was demonstrated for highly visco-plastic materials while shear-sensitivity in feeding was demonstrated for lubricated blends of ductile particles. Strategies for the compensation of both in compaction simulator experiments are presented by careful investigation of the compaction stress over time profiles and introduction of a compaction simulator-adapted shear number approach to account for differences in layout and operation mode between compaction simulator and rotary press, respectively. These approaches support the general aim of this study to provide a more straightforward determination of scaling process parameters between rotary press and compaction simulator and facilitate a quicker and more reliable process transfer.
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spelling pubmed-72382352020-06-02 Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes Wünsch, Isabell Friesen, Irene Puckhaber, Daniel Schlegel, Thomas Finke, Jan Henrik Pharmaceutics Article Compaction simulators are frequently used in the formulation and process development of tablets, bringing about the advantages of flexibility, low material consumption, and high instrumentation to generate the most possible process understanding. However, their capability of resembling general aspects of rotary press compaction and their precision in simulating or mimicking sub-processes such as feeding and filling need to be systematically studied. The effect of material deformation behavior, blend composition, and feeding on tensile strength and simulation precision as compared with rotary presses of different scales is evaluated in this study. Generally, good simulation performance was found for the studied compaction simulator. Compaction profile-sensitivity was demonstrated for highly visco-plastic materials while shear-sensitivity in feeding was demonstrated for lubricated blends of ductile particles. Strategies for the compensation of both in compaction simulator experiments are presented by careful investigation of the compaction stress over time profiles and introduction of a compaction simulator-adapted shear number approach to account for differences in layout and operation mode between compaction simulator and rotary press, respectively. These approaches support the general aim of this study to provide a more straightforward determination of scaling process parameters between rotary press and compaction simulator and facilitate a quicker and more reliable process transfer. MDPI 2020-03-31 /pmc/articles/PMC7238235/ /pubmed/32244401 http://dx.doi.org/10.3390/pharmaceutics12040310 Text en © 2020 by the authors. 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 (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Wünsch, Isabell
Friesen, Irene
Puckhaber, Daniel
Schlegel, Thomas
Finke, Jan Henrik
Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title_full Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title_fullStr Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title_full_unstemmed Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title_short Scaling Tableting Processes from Compaction Simulator to Rotary Presses—Mind the Sub-Processes
title_sort scaling tableting processes from compaction simulator to rotary presses—mind the sub-processes
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238235/
https://www.ncbi.nlm.nih.gov/pubmed/32244401
http://dx.doi.org/10.3390/pharmaceutics12040310
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