Stabilized albumin-free recombinant factor VII preparation havin

Details Stabilized albumin-free recombinant factor VII preparation havin Stabilized albumin-free recombinant factor VII preparation havin

1998-05-28

1999-02-23

Moezie, F.T.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

514 21, 530383, A61K 3516, A61K 3816, A61K 3800

Patent

active

058744088

ABSTRACT:
A stable albumin-free Recombinant Factor VIII (rFVIII) formulation in lyophilized form having both crystalline and amorphous components and comprising, when reconstituted with water, about 65 to 400 mM glycine, up to 50 mM histidine, 15 to 60 mM sucrose, up to 50 mM NaCl (up to 100 mM NaCl if cake appearance not critical), up to 5 mM CaCl.sub.2 and 50 to 1500 lU/ml of rFVIII. A very preferred formulation comprises upon reconstitution with water about 290 mM glycine, 20 mM histidine, 30 mM sucrose, 30 mM NaCl, 2.5 mM CaCl.sub.2 and 50 to 1500 lU/ml of rFVIII. The residual water content of the lyophilized preparation is about 1 to 3% by weight, preferably about 1% by weight.

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