Protein formulation comprising coagulation factor viii or...

Details Protein formulation comprising coagulation factor viii or... Protein formulation comprising coagulation factor viii or...

A - Human Necessities

61

K

A61K 38/37 (2006.01) A61K 38/36 (2006.01) A61K 38/48 (2006.01) A61K 38/57 (2006.01) C07K 14/755 (2006.01)

Patent

CA 2216098

The present invention relates to a final drug product of a plasma protein selected from the group consisting of coagulation factor VIII and factor IX, in a aqueous solution, wherein the concentration of oxygen in the solution is reduced and/or the solution contains an antioxidant, and wherein the solution further contains a carbohydrate in a concentration of at least 350 mg/ml. In this way, the protein activity can be essentially retained after storage for at least 6 months. The present invention also relates to a process for preparing the final drug product, and a method for improving the long-term stability of coagulation factor VIII and factor IX in an aqueous solution, wherein the solution contains a carbohydrate in a concentration of at least 350 mg/ml, and wherein the solution is stored in its final container under an oxygen-reduced atmosphere.

L'invention concerne un produit médicamenteux final constitué d'une protéine plasmique choisie dans le groupe comprenant les facteurs de coagulation VIII et IX, dans une solution aqueuse à concentration d'oxygène réduite et/ou contenant un antioxydant. Ladite solution contient également un glucide à raison d'au moins 350 mg/ml. Ainsi, l'activité de laprotéine peut être maintenue après un stockage d'au moins six mois. L'invention porte également sur un procédé de préparation dudit produit médicamenteux final, sur un procédé permettant d'améliorer la stabilité à long terme des facteurs de coagulation VIII et IX dans une solution aqueuse, laquelle contient un glucide à raison d'au moins 350 mg/ml et est stockée dans son récipient définitif dans une atmosphère à teneur réduite en oxygène.

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