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Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing
The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10537298/ https://www.ncbi.nlm.nih.gov/pubmed/37765286 http://dx.doi.org/10.3390/pharmaceutics15092317 |
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author | Forster, Seth P. Dippold, Erin Haser, Abbe Emanuele, Daniel Meier, Robin |
author_facet | Forster, Seth P. Dippold, Erin Haser, Abbe Emanuele, Daniel Meier, Robin |
author_sort | Forster, Seth P. |
collection | PubMed |
description | The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging to move towards continuous processing since traditional equipment has been predominantly strictly batch, instead of readily adapted to material flow such as dry granulation or tablet compression, and there have been few equipment options for continuous granule drying. Recently, pilot and commercial scale equipment combining a twin-screw wet granulator and a novel horizontal vibratory fluid-bed dryer have been developed. This study describes the process space of that equipment and compares the granules produced with batch high-shear and fluid-bed wet granulation processes. The results of this evaluation demonstrate that the equipment works across a range of formulations, effectively granulates and dries, and produces granules of similar or improved quality to batch wet granulation and drying. |
format | Online Article Text |
id | pubmed-10537298 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-105372982023-09-29 Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing Forster, Seth P. Dippold, Erin Haser, Abbe Emanuele, Daniel Meier, Robin Pharmaceutics Article The pharmaceutical industry is in the midst of a transition from traditional batch processes to continuous manufacturing. However, the challenges in making this transition vary depending on the selected manufacturing process. Compared with other oral solid dosage processes, wet granulation has been challenging to move towards continuous processing since traditional equipment has been predominantly strictly batch, instead of readily adapted to material flow such as dry granulation or tablet compression, and there have been few equipment options for continuous granule drying. Recently, pilot and commercial scale equipment combining a twin-screw wet granulator and a novel horizontal vibratory fluid-bed dryer have been developed. This study describes the process space of that equipment and compares the granules produced with batch high-shear and fluid-bed wet granulation processes. The results of this evaluation demonstrate that the equipment works across a range of formulations, effectively granulates and dries, and produces granules of similar or improved quality to batch wet granulation and drying. MDPI 2023-09-14 /pmc/articles/PMC10537298/ /pubmed/37765286 http://dx.doi.org/10.3390/pharmaceutics15092317 Text en © 2023 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 Forster, Seth P. Dippold, Erin Haser, Abbe Emanuele, Daniel Meier, Robin Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title | Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title_full | Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title_fullStr | Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title_full_unstemmed | Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title_short | Integrated Continuous Wet Granulation and Drying: Process Evaluation and Comparison with Batch Processing |
title_sort | integrated continuous wet granulation and drying: process evaluation and comparison with batch processing |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10537298/ https://www.ncbi.nlm.nih.gov/pubmed/37765286 http://dx.doi.org/10.3390/pharmaceutics15092317 |
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