Cargando…
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...
Autores principales: | , , , , , , |
---|---|
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 |
_version_ | 1782458133868707840 |
---|---|
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. |
format | Online Article Text |
id | pubmed-5051734 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT kanojiagaurav theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT haverimkoten theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT bakkerarjen theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT wagnerkoen theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT frijlinkhenderikw theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT kerstengideonfa theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT amorijjeanpierre theproductionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT kanojiagaurav productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT haverimkoten productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT bakkerarjen productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT wagnerkoen productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT frijlinkhenderikw productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT kerstengideonfa productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction AT amorijjeanpierre productionofastableinfliximabpowdertheevaluationofsprayandfreezedryingforproduction |