High Concentration Factor VII Polypeptide Formulations Comprising an Aromatic Preservative and an Antioxidant

摘要

The present invention relates to pharmaceutical compositions comprising at least 10 mg/mL of a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 5.0 to about 9.0; at least one aromatic preservative (iii) in a concentration of at least 0.1 mg/mL; and at least one antioxidant (iv) in a concentration of at least 0.1 mg/mL; the composition optionally comprising further components, with the proviso that none of such further components are Factor VII polypeptide stabilizing agents selected from (a) metal-containing agents, wherein said metal is selected from the group consisting of first transition series metals of oxidation state +II, except zinc; and (b) stabilising agent comprising a—C(═N—Z1-R1)-NH—Z2-R2 motif.