High concentration antibody and protein formulations

Details High concentration antibody and protein formulations High concentration antibody and protein formulations

A - Human Necessities

61

K

A61K 47/18 (2006.01) A61K 39/395 (2006.01) A61K 47/06 (2006.01) C07K 16/18 (2006.01)

Patent

CA 2519408

The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein. The formulations comprise arginine-HC1, histidine and polysorbate.

L'invention concerne des préparations d'anticorps et de protéines à forte concentration, à viscosité réduite, qui sont stables, relativement isotoniques et présentent une faible turbidité. Ces préparations se prêtent particulièrement bien à des une administration sous-cutanée. Sont également décrits des articles manufacturés renfermant de telles préparations et une méthode d'utilisation de ces dernières pour le traitement de troubles pouvant être traités par l'anticorps ou la protéine de ladite préparation. Les préparations de l'invention contiennent de l'arginine-HC1, de l'histidine et du polysorbate.

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