In prospect of developing an oral dosage form of Infliximab, for treatment of Crohnâ��s disease\nand rheumatoid arthritis, freeze-drying (vial vs Lyoguard trays) and spray-drying were\ninvestigated as production method for stable powders. Dextran and inulin were used in\ncombination with sucrose as stabilizing excipients. The drying processes did not affect\nInfliximab in these formulations, i.e. both the physical integrity and biological activity (TNF\nbinding) were retained. Accelerated stability studies (1 month at 60�šC) showed that the\nTNF binding ability of Infliximab was conserved in the freeze-dried formulations, whereas\nthe liquid counterpart lost all TNF binding. After thermal treatment, the dried formulations\nshowed some chemical modification of the IgG in the dextran-sucrose formulation, probably\ndue to Maillard reaction products. This study indicates that, with the appropriate formulation,\nboth spray-drying and freeze-drying may be useful for (bulk) powder production of\nInfliximab.
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