US 12,440,567 B2
Aqueous antibody formulation stabilized by antioxidants for parenteral administration
Christopher James Sloey, Thousand Oaks, CA (US); Jason Ko, Thousand Oaks, CA (US); and Tiansheng Li, Thousand Oaks, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Filed by AMGEN INC., Thousand Oaks, CA (US)
Filed on Sep. 1, 2022, as Appl. No. 17/929,232.
Application 17/929,232 is a division of application No. 14/305,450, filed on Jun. 16, 2014, granted, now 11,433,134.
Application 14/305,450 is a division of application No. 12/743,333, granted, now 8,796,206, previously published as PCT/US2008/083327, filed on Nov. 13, 2008.
Claims priority of provisional application 60/988,354, filed on Nov. 15, 2007.
Prior Publication US 2023/0126688 A1, Apr. 27, 2023
Int. Cl. A61K 39/00 (2006.01); A61K 9/00 (2006.01); A61K 38/18 (2006.01); A61K 39/395 (2006.01); A61K 47/12 (2006.01); A61K 47/22 (2006.01); C07K 16/00 (2006.01)
CPC A61K 47/12 (2013.01) [A61K 9/0019 (2013.01); A61K 38/1816 (2013.01); A61K 39/3955 (2013.01); A61K 39/39591 (2013.01); A61K 47/22 (2013.01)] 9 Claims
 
1. An aqueous formulation comprising (i) at least 0.1 mg/ml of a therapeutic antibody and (ii) an antioxidant in a concentration of about 0.01 mM to about 0.1 mM, wherein the antioxidant is coumaric acid, ferulic acid, a pharmaceutically acceptable salt or ester of coumaric acid, a pharmaceutically acceptable salt or ester of ferulic acid, or a mixture of coumaric acid and ferulic acid, wherein:
the therapeutic antibody exhibits less than about 10% degradation as determined by exposure for about 3 hours to a 8 watt mid UV lamp having a spectral distribution from 270 nm to 360 nm with a maximum energy emission of about 302 nm; and
the formulation is suitable for parenteral administration.