High concentration factor VII polypeptide formulations comprising an aromatic preservative and an antioxidant
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United States of America Patent
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Nov 17, 2015
Grant Date -
Nov 25, 2010
app pub date -
Apr 30, 2008
filing date -
May 2, 2007
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Abstract
The present invention relates to pharmaceutical compositions comprising: (i) at least 10 mg/mL of a Factor VII polypeptide; (ii) a buffering agent suitable for keeping pH in the 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; and (iv) at least one antioxidant in a concentration of at least 0.1 mg/mL; the composition optionally comprising further components, with the proviso that such further components are not 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) stabilizing agents comprising a —C(═N—Z1-R1)-NH—Z2-R2 motif.
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