HIGH CONCENTRATION FACTOR VII POLYPEPTIDE FORMULATION CONTAINING AROMATIC PRESERVATIVE AND ANTI-OXIDANT

摘要

PROBLEM TO BE SOLVED: To provide a Factor VII polypeptide formulation (hereinafter, liquid aqueous pharmaceutical composition) having excellent stability.SOLUTION: A pharmaceutical composition contains at least 10 mg/ml of a Factor VII polypeptide (i), a buffer agent suitable for keeping the pH in the range of about 5.0 to about 9.0 (ii), at least one aromatic preservative having a concentration of at least 0.1 mg/ml (iii), and at least one anti-oxidant having a concentration of at least 0.1 mg/ml (iv). The composition optionally comprises a further component, but the further component is not any of Factor VII polypeptide stabilizers selected from (a) an agent containing a metal selected from the group consisting of first transition series metals of oxidation state + II except for zinc and (b) stabilizers containing -C(=N-Z-R-NH-Z-Rmotif.