Liquid, aqueous pharmaceutical compositions of factor VII...

Details Liquid, aqueous pharmaceutical compositions of factor VII... Liquid, aqueous pharmaceutical compositions of factor VII...

2006-02-14

2010-06-08

Kam, Chih-Min (Department: 1656)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

C514S597000, C530S350000, C530S384000

Reexamination Certificate

active

07732405

ABSTRACT:
The present invention is directed to liquid, aqueous pharmaceutical compositions stabilized against chemical and/or physical degradation containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising at least 0.01 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; and at least one stabilizing agent (iii) comprising a —C(═N-Z1-R1)—NH-Z2-R2motif, e.g. benzamidine compounds and guanidine compounds such as arginine.

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