Novo Nordisk Healthcare Ag

Andrew Neil Bowler

Anders Klarskov Petersen

Michael Bech Jensen

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 &#x2014;C(&#x2550;N&#x2014;Z&#x2014;R)&#x2014;NH&#x2014;Z&#x2014;Rmotif, e.g. benzamidine compounds and guanidine compounds such as arginine.

Liquid, aqueous pharmaceutical compositions of factor VII polypeptides

The present invention is directed to liquid, aqueous pharmaceutical compositions stabilised 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 stabilising agent (iii) comprising a &#x2014;C(&#x2550;N&#x2014;Z&#x2014;R)&#x2014;NH&#x2014;Z&#x2014;Rmotif, e.g. benzamidine compounds and guanidine compounds such as arginine.

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 &#x2014;C(&#x2550;N-Z-R)&#x2014;NH-Z-Rmotif, e.g. benzamidine compounds and guanidine compounds such as arginine.

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Gentofte, Denmark

Andrew Neil Bowler