US 11,951,207 B2
Stable liquid pharmaceutical preparation
Joon Won Lee, Incheon (KR); Won Yong Han, Incheon (KR); Su Jung Kim, Incheon (KR); Jun Seok Oh, Incheon (KR); So Young Kim, Incheon (KR); Su Hyeon Hong, Incheon (KR); and Yeon Kyeong Shin, Incheon (KR)
Assigned to Celltrion Inc., Incheon (KR)
Appl. No. 16/310,585
Filed by Celltrion Inc., Incheon (KR)
PCT Filed Jun. 28, 2017, PCT No. PCT/KR2017/006855
§ 371(c)(1), (2) Date Dec. 17, 2018,
PCT Pub. No. WO2018/004260, PCT Pub. Date Jan. 4, 2018.
Claims priority of application No. 10-2016-0083039 (KR), filed on Jun. 30, 2016.
Prior Publication US 2021/0000743 A1, Jan. 7, 2021
Int. Cl. A61K 9/08 (2006.01); A61K 39/00 (2006.01); A61K 39/395 (2006.01); A61P 37/02 (2006.01); A61P 37/04 (2006.01); A61P 37/06 (2006.01); C07K 16/00 (2006.01); C07K 16/24 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01)
CPC A61K 9/08 (2013.01) [A61K 39/00 (2013.01); A61K 39/395 (2013.01); A61P 37/02 (2018.01); A61P 37/04 (2018.01); A61P 37/06 (2018.01); C07K 16/00 (2013.01); C07K 16/241 (2013.01); A61K 2039/505 (2013.01); A61K 47/10 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); C07K 2317/622 (2013.01)] 14 Claims
 
1. A stable liquid pharmaceutical formulation, comprising:
(A) 90 to 145 mg/ml of infliximab;
(B) 0.02 to 0.1% (w/v) of a surfactant comprising polysorbate 80;
(C) 1 to 10% (w/v) of a sugar comprising sorbitol; and
(D) 1 to 50 mM of a buffer comprising sodium acetate.