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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...

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Detalles Bibliográficos
Autores principales: Forster, Seth P., Dippold, Erin, Haser, Abbe, Emanuele, Daniel, Meier, Robin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
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.
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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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