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Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development

[Image: see text] Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration an...

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Autores principales: Ottoboni, Sara, Coleman, Simon J., Steven, Christopher, Siddique, Mariam, Fraissinet, Marine, Joannes, Marion, Laux, Audrey, Barton, Alastair, Firth, Paul, Price, Chris J., Mulheran, Paul A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Chemical Society 2020
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685224/
https://www.ncbi.nlm.nih.gov/pubmed/33250628
http://dx.doi.org/10.1021/acs.oprd.0c00035
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author Ottoboni, Sara
Coleman, Simon J.
Steven, Christopher
Siddique, Mariam
Fraissinet, Marine
Joannes, Marion
Laux, Audrey
Barton, Alastair
Firth, Paul
Price, Chris J.
Mulheran, Paul A.
author_facet Ottoboni, Sara
Coleman, Simon J.
Steven, Christopher
Siddique, Mariam
Fraissinet, Marine
Joannes, Marion
Laux, Audrey
Barton, Alastair
Firth, Paul
Price, Chris J.
Mulheran, Paul A.
author_sort Ottoboni, Sara
collection PubMed
description [Image: see text] Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing prototypes for pharmaceutical process development and small-scale manufacture. Here, we address the challenge of static drying of a solvent-wet crystalline API in a fixed bed to facilitate the design of a continuous filter dryer for pharmaceutical development, without excessive particle breakage or the formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a time scale suitable for continuous manufacturing, complemented by the development of a drying model that provides a design tool for process development. We also evaluate the impact of alternative washing and drying approaches on particle agglomeration. We conclude that our approach yields effective technology, with a performance that is amenable to predictive modeling.
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spelling pubmed-76852242020-11-25 Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development Ottoboni, Sara Coleman, Simon J. Steven, Christopher Siddique, Mariam Fraissinet, Marine Joannes, Marion Laux, Audrey Barton, Alastair Firth, Paul Price, Chris J. Mulheran, Paul A. Org Process Res Dev [Image: see text] Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing prototypes for pharmaceutical process development and small-scale manufacture. Here, we address the challenge of static drying of a solvent-wet crystalline API in a fixed bed to facilitate the design of a continuous filter dryer for pharmaceutical development, without excessive particle breakage or the formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a time scale suitable for continuous manufacturing, complemented by the development of a drying model that provides a design tool for process development. We also evaluate the impact of alternative washing and drying approaches on particle agglomeration. We conclude that our approach yields effective technology, with a performance that is amenable to predictive modeling. American Chemical Society 2020-10-16 2020-11-20 /pmc/articles/PMC7685224/ /pubmed/33250628 http://dx.doi.org/10.1021/acs.oprd.0c00035 Text en © 2020 American Chemical Society This is an open access article published under a Creative Commons Attribution (CC-BY) License (http://pubs.acs.org/page/policy/authorchoice_ccby_termsofuse.html) , which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
spellingShingle Ottoboni, Sara
Coleman, Simon J.
Steven, Christopher
Siddique, Mariam
Fraissinet, Marine
Joannes, Marion
Laux, Audrey
Barton, Alastair
Firth, Paul
Price, Chris J.
Mulheran, Paul A.
Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title_full Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title_fullStr Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title_full_unstemmed Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title_short Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
title_sort understanding api static drying with hot gas flow: design and test of a drying rig prototype and drying modeling development
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685224/
https://www.ncbi.nlm.nih.gov/pubmed/33250628
http://dx.doi.org/10.1021/acs.oprd.0c00035
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