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Solvent-Assisted Secondary Drying of Spray-Dried Polymers
PURPOSE: The purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingred...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395053/ https://www.ncbi.nlm.nih.gov/pubmed/32737611 http://dx.doi.org/10.1007/s11095-020-02890-0 |
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author | Shepard, Kimberly B. Dower, April M. Ekdahl, Alyssa M. Morgen, Michael M. Baumann, John M. Vodak, David T. |
author_facet | Shepard, Kimberly B. Dower, April M. Ekdahl, Alyssa M. Morgen, Michael M. Baumann, John M. Vodak, David T. |
author_sort | Shepard, Kimberly B. |
collection | PubMed |
description | PURPOSE: The purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spray-drying process, API and excipients are co-dissolved in a volatile organic solvent, atomized into droplets through a nozzle, and introduced to a drying chamber containing heated nitrogen gas. The product dries rapidly to form a powder, but small amounts of residual solvent (typically, 1 to 10 wt%) remain in the product and must be removed in a secondary-drying process. For some spray-dried materials, secondary drying by traditional techniques can take days and requires balancing stability risks with process time. METHODS: Spray-dried polymers were secondary dried, comparing the results for three state-of-the-art methods that employed a jacketed, agitated-vessel dryer: (1) vacuum-only drying, (2) water-assisted drying, or (3) methanol-assisted drying. Samples of material were pulled at various time points and analyzed by gas chromatography (GC) and Karl Fischer (KF) titration to track the drying process. RESULTS: Model systems were chosen for which secondary drying is slow. For all cases studied, methanol-assisted drying outperformed the vacuum-only and water-assisted drying methods. CONCLUSIONS: The observation that methanol-assisted drying is more effective than the other drying techniques is consistent with the free-volume theory of solvent diffusion in polymers. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11095-020-02890-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-7395053 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-73950532020-08-18 Solvent-Assisted Secondary Drying of Spray-Dried Polymers Shepard, Kimberly B. Dower, April M. Ekdahl, Alyssa M. Morgen, Michael M. Baumann, John M. Vodak, David T. Pharm Res Research Paper PURPOSE: The purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spray-drying process, API and excipients are co-dissolved in a volatile organic solvent, atomized into droplets through a nozzle, and introduced to a drying chamber containing heated nitrogen gas. The product dries rapidly to form a powder, but small amounts of residual solvent (typically, 1 to 10 wt%) remain in the product and must be removed in a secondary-drying process. For some spray-dried materials, secondary drying by traditional techniques can take days and requires balancing stability risks with process time. METHODS: Spray-dried polymers were secondary dried, comparing the results for three state-of-the-art methods that employed a jacketed, agitated-vessel dryer: (1) vacuum-only drying, (2) water-assisted drying, or (3) methanol-assisted drying. Samples of material were pulled at various time points and analyzed by gas chromatography (GC) and Karl Fischer (KF) titration to track the drying process. RESULTS: Model systems were chosen for which secondary drying is slow. For all cases studied, methanol-assisted drying outperformed the vacuum-only and water-assisted drying methods. CONCLUSIONS: The observation that methanol-assisted drying is more effective than the other drying techniques is consistent with the free-volume theory of solvent diffusion in polymers. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11095-020-02890-0) contains supplementary material, which is available to authorized users. Springer US 2020-07-31 2020 /pmc/articles/PMC7395053/ /pubmed/32737611 http://dx.doi.org/10.1007/s11095-020-02890-0 Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Research Paper Shepard, Kimberly B. Dower, April M. Ekdahl, Alyssa M. Morgen, Michael M. Baumann, John M. Vodak, David T. Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title | Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title_full | Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title_fullStr | Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title_full_unstemmed | Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title_short | Solvent-Assisted Secondary Drying of Spray-Dried Polymers |
title_sort | solvent-assisted secondary drying of spray-dried polymers |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395053/ https://www.ncbi.nlm.nih.gov/pubmed/32737611 http://dx.doi.org/10.1007/s11095-020-02890-0 |
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