Patent ID: 9186323
Filing Date: 2015-11-17
Classification: A61K,A61P,C12N,C12Y

Abstract:
1. A liquid aqueous pharmaceutical composition comprising a formulation of: (i) at least 10 mg/mL of a Factor VII polypeptide; (ii) a buffering agent suitable for keeping the pH of the composition in a range of from about 5.0 to about 9.0; (iii) at least one aromatic preservative in a concentration of at least 0.1 mg/mL, wherein the aromatic preservative is selected from the group consisting of phenol, benzyl alcohol, orto-cresol, meta-cresol, para-cresol, methyl paraben, propyl paraben, benzalkonium chloride, and benzethonium chloride; (iv) at least one antioxidant in a concentration of at least 0.1 mg/mL; wherein the composition does not contain a Factor VII polypeptide stabilizing agent selected from the group consisting of (a) a metal-containing agent, wherein the metal is a first transition series metal of oxidation state +II with the exception of zinc; and (b) a stabilising agent comprising a —C(═N—Z (v) a pharmaceutically acceptable carrier.