US 5,962,650 A · Oxygen-reduced aqueous solution of factor VIII

Abstract

The present invention relates to a final drug product comprising coagulation factor VIII in an aqueous solution with a reduced concentration of oxygen. In this way, the factor VIII activity can be retained during storage to a surprisingly high degree. The factor VIII activity can be retained for a prolonged period of time, if the final drug product further comprises an inert gas and/or an antioxidant. The present invention also relates to processes for reducing the oxygen concentration of the aqueous solution, and a method for improving the stability of factor VIII in an aqueous solution by storing the solution under an inert gas atmosphere. By the present invention it is possible to retain at least 50% of the initial activity of factor VIII after storage for at least 6 months at a temperature of 2 to 10.degree. C. and a pH of the solution of 6.5 to 8.5.

Claims16

Dependent claims

A formulation comprising coagulation factor VIII ready for use, wherein said factor VIII has an activity of 10 to 100,000 IU/ml in an aqueous solution with a concentration of oxygen below 200 ppm and capable of retaining at least 50% of its initial activity after storage for at least 6 months, and wherein the aqueous solution contains:

i) 10-100,000 IU/ml of recombinant coagulation factor VIII,
ii) at least 0.01 mg/ml of a polyoxyethylene sorbitan fatty acid ester,
iii) sodium chloride,
iv) calcium salt,
v) an amino acid in an amount of more than 1 mM, and
vi) a Mono- or disaccharide or a sugar alcohol, and is free of albumin.

3 more elements

Dependencies are inferred from the claim text.

Oxygen-reduced aqueous solution of factor VIII

Life of this patent

Oxygen-reduced aqueous solution of factor VIII

Life of this patent

Abstract

Claims16