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The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production

In prospect of developing an oral dosage form of Infliximab, for treatment of Crohn’s disease and rheumatoid arthritis, freeze-drying (vial vs Lyoguard trays) and spray-drying were investigated as production method for stable powders. Dextran and inulin were used in combination with sucrose as stabi...

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Autores principales: Kanojia, Gaurav, Have, Rimko ten, Bakker, Arjen, Wagner, Koen, Frijlink, Henderik W., Kersten, Gideon F. A., Amorij, Jean-Pierre
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051734/
https://www.ncbi.nlm.nih.gov/pubmed/27706175
http://dx.doi.org/10.1371/journal.pone.0163109
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author Kanojia, Gaurav
Have, Rimko ten
Bakker, Arjen
Wagner, Koen
Frijlink, Henderik W.
Kersten, Gideon F. A.
Amorij, Jean-Pierre
author_facet Kanojia, Gaurav
Have, Rimko ten
Bakker, Arjen
Wagner, Koen
Frijlink, Henderik W.
Kersten, Gideon F. A.
Amorij, Jean-Pierre
author_sort Kanojia, Gaurav
collection PubMed
description In prospect of developing an oral dosage form of Infliximab, for treatment of Crohn’s disease and rheumatoid arthritis, freeze-drying (vial vs Lyoguard trays) and spray-drying were investigated as production method for stable powders. Dextran and inulin were used in combination with sucrose as stabilizing excipients. The drying processes did not affect Infliximab in these formulations, i.e. both the physical integrity and biological activity (TNF binding) were retained. Accelerated stability studies (1 month at 60°C) showed that the TNF binding ability of Infliximab was conserved in the freeze-dried formulations, whereas the liquid counterpart lost all TNF binding. After thermal treatment, the dried formulations showed some chemical modification of the IgG in the dextran-sucrose formulation, probably due to Maillard reaction products. This study indicates that, with the appropriate formulation, both spray-drying and freeze-drying may be useful for (bulk) powder production of Infliximab.
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spelling pubmed-50517342016-10-27 The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production Kanojia, Gaurav Have, Rimko ten Bakker, Arjen Wagner, Koen Frijlink, Henderik W. Kersten, Gideon F. A. Amorij, Jean-Pierre PLoS One Research Article In prospect of developing an oral dosage form of Infliximab, for treatment of Crohn’s disease and rheumatoid arthritis, freeze-drying (vial vs Lyoguard trays) and spray-drying were investigated as production method for stable powders. Dextran and inulin were used in combination with sucrose as stabilizing excipients. The drying processes did not affect Infliximab in these formulations, i.e. both the physical integrity and biological activity (TNF binding) were retained. Accelerated stability studies (1 month at 60°C) showed that the TNF binding ability of Infliximab was conserved in the freeze-dried formulations, whereas the liquid counterpart lost all TNF binding. After thermal treatment, the dried formulations showed some chemical modification of the IgG in the dextran-sucrose formulation, probably due to Maillard reaction products. This study indicates that, with the appropriate formulation, both spray-drying and freeze-drying may be useful for (bulk) powder production of Infliximab. Public Library of Science 2016-10-05 /pmc/articles/PMC5051734/ /pubmed/27706175 http://dx.doi.org/10.1371/journal.pone.0163109 Text en © 2016 Kanojia et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Kanojia, Gaurav
Have, Rimko ten
Bakker, Arjen
Wagner, Koen
Frijlink, Henderik W.
Kersten, Gideon F. A.
Amorij, Jean-Pierre
The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title_full The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title_fullStr The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title_full_unstemmed The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title_short The Production of a Stable Infliximab Powder: The Evaluation of Spray and Freeze-Drying for Production
title_sort production of a stable infliximab powder: the evaluation of spray and freeze-drying for production
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5051734/
https://www.ncbi.nlm.nih.gov/pubmed/27706175
http://dx.doi.org/10.1371/journal.pone.0163109
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