Immunoglobulin formulation and method of preparation thereof

A - Human Necessities – 61 – K

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Details

A61K 39/00 (2006.01) A61K 39/38 (2006.01) A61K 39/395 (2006.01) C07K 1/00 (2006.01)

Patent

CA 2515444

A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight.

L'invention a trait à une préparation pharmaceutique aqueuse stable, qui contient une dose thérapeutiquement efficace d'un anticorps, du polysorbate 80, un tampon qui inhibe l'oxydation du polysorbate, ainsi qu'à des procédés de production de ladite préparation. L'invention concerne également des préparations contenant une concentration d'anticorps élevée, qui conservent un volume fixe et qui peuvent être utilisées sur des patients de poids variable.

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