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...

Full description

Saved in:
Bibliographic Details
Published in:PloS one 2016-10, Vol.11 (10), p.e0163109-e0163109
Main Authors: Kanojia, Gaurav, Have, Rimko Ten, Bakker, Arjen, Wagner, Koen, Frijlink, Henderik W, Kersten, Gideon F A, Amorij, Jean-Pierre
Format: Article
Language:English
Subjects:
Analysis
Arthritis
Binding
Biological activity
Biological products
Biology and Life Sciences
Chemical modification
Chromatography, Gel
Dextran
Dextrans
Dextrans - chemistry
Drug Compounding - methods
Drug Stability
Electrophoresis, Polyacrylamide Gel
Feasibility studies
Formulations
Freeze Drying
Heat treatment
Hydrogen
Immunoglobulin G
Immunoglobulins
Immunotherapy
Infliximab
Infliximab - analysis
Infliximab - chemistry
Inulin
Inulin - chemistry
Maillard Reaction
Maillard reaction products
Medical treatment
Monoclonal antibodies
Pharmaceutical industry
Pharmaceutical sciences
Physical Sciences
Powder
Powders (Particulate matter)
Proteins
Research and Analysis Methods
Rheumatoid arthritis
Rheumatoid factor
Sucrose
Sucrose - chemistry
Sugar
Trays
Tumor necrosis factor
Tumor necrosis factor-TNF
Tumor necrosis factor-α
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0163109