US 11,813,328 B2
Methods for reducing the viscosity of liquid pharmaceutical formulations comprising therapeutic proteins
Christopher James Sloey, Newbury Park, CA (US); and Sekhar Kanapuram, Thousand Oaks, CA (US)
Assigned to AMGEN INC., Thousand Oaks, CA (US)
Appl. No. 15/521,057
Filed by AMGEN INC., Thousand Oaks, CA (US)
PCT Filed Oct. 22, 2015, PCT No. PCT/US2015/056972
§ 371(c)(1), (2) Date Apr. 21, 2017,
PCT Pub. No. WO2016/065181, PCT Pub. Date Apr. 28, 2016.
Claims priority of provisional application 62/067,637, filed on Oct. 23, 2014.
Prior Publication US 2017/0333559 A1, Nov. 23, 2017
Int. Cl. A61K 39/395 (2006.01); A61K 47/18 (2017.01); A61K 9/19 (2006.01); A61K 9/00 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/19 (2013.01); A61K 39/3955 (2013.01); A61K 47/183 (2013.01); A61K 9/0019 (2013.01); C07K 2317/90 (2013.01)] 35 Claims
 
1. A method for reducing the viscosity of a liquid pharmaceutical formulation comprising an antibody at a concentration of at least 70 mg/ml, comprising combining the antibody with a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl histidine, n-acetyl proline and mixtures thereof, wherein the viscosity of the liquid pharmaceutical formulation is reduced by at least 5% versus a control formulation.