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The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters

For the efficient and safe production of pharmaceutical tablets, a deep process understanding is of high importance. An essential process step during tableting is the die filling, as it is responsible for a consistent tablet weight and drug content. Furthermore, it affects the results of subsequent...

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Autores principales: Schomberg, Ann Kathrin, Kwade, Arno, Finke, Jan Henrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150958/
https://www.ncbi.nlm.nih.gov/pubmed/32164230
http://dx.doi.org/10.3390/pharmaceutics12030248
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author Schomberg, Ann Kathrin
Kwade, Arno
Finke, Jan Henrik
author_facet Schomberg, Ann Kathrin
Kwade, Arno
Finke, Jan Henrik
author_sort Schomberg, Ann Kathrin
collection PubMed
description For the efficient and safe production of pharmaceutical tablets, a deep process understanding is of high importance. An essential process step during tableting is the die filling, as it is responsible for a consistent tablet weight and drug content. Furthermore, it affects the results of subsequent process steps, compaction and ejection, and thus critical quality attributes. This study focuses on understanding the influences of process parameters and material properties on die filling on a rotary tablet press. By the systematic variation in process parameters as the turret and paddle speeds as well as the fill and dosing depths, five formulations with differing properties are processed. Analysis of the normalized tablet weight, called filling yield, revealed different limitation mechanisms of the filling process, i.e., incomplete filled dies for certain parameter settings. Kinetic limitations occur due to a short residence time under the feed frame (filling time) caused by high turret speeds, which additionally induce high tablet weight variation coefficients. Characteristic maximum turret speeds at certain paddle speeds can be found to still achieve complete filling. At low turret speeds, densification of the powder inside the dies takes place, induced by two mechanisms: either high paddle speeds or high overfill ratios, or a combination of both. The challenge to fill the dies completely as well as avoid densification is dependent on material properties as the flowability. The mass discharge rate from an orifice was found to be in a linear correlation to the filling results of different formulations below complete filling.
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spelling pubmed-71509582020-04-20 The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters Schomberg, Ann Kathrin Kwade, Arno Finke, Jan Henrik Pharmaceutics Article For the efficient and safe production of pharmaceutical tablets, a deep process understanding is of high importance. An essential process step during tableting is the die filling, as it is responsible for a consistent tablet weight and drug content. Furthermore, it affects the results of subsequent process steps, compaction and ejection, and thus critical quality attributes. This study focuses on understanding the influences of process parameters and material properties on die filling on a rotary tablet press. By the systematic variation in process parameters as the turret and paddle speeds as well as the fill and dosing depths, five formulations with differing properties are processed. Analysis of the normalized tablet weight, called filling yield, revealed different limitation mechanisms of the filling process, i.e., incomplete filled dies for certain parameter settings. Kinetic limitations occur due to a short residence time under the feed frame (filling time) caused by high turret speeds, which additionally induce high tablet weight variation coefficients. Characteristic maximum turret speeds at certain paddle speeds can be found to still achieve complete filling. At low turret speeds, densification of the powder inside the dies takes place, induced by two mechanisms: either high paddle speeds or high overfill ratios, or a combination of both. The challenge to fill the dies completely as well as avoid densification is dependent on material properties as the flowability. The mass discharge rate from an orifice was found to be in a linear correlation to the filling results of different formulations below complete filling. MDPI 2020-03-10 /pmc/articles/PMC7150958/ /pubmed/32164230 http://dx.doi.org/10.3390/pharmaceutics12030248 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
Schomberg, Ann Kathrin
Kwade, Arno
Finke, Jan Henrik
The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title_full The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title_fullStr The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title_full_unstemmed The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title_short The Challenge of Die Filling in Rotary Presses—A Systematic Study of Material Properties and Process Parameters
title_sort challenge of die filling in rotary presses—a systematic study of material properties and process parameters
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7150958/
https://www.ncbi.nlm.nih.gov/pubmed/32164230
http://dx.doi.org/10.3390/pharmaceutics12030248
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