US 12,433,947 B2
Stable formulations of therapeutic antibody
Murali Jayaraman, Kancheepuram (IN); and Anuja Chandrasekar, Chennai (IN)
Assigned to DR. REDDY'S LABORATORIES LIMITED, Hyderabad (IN)
Appl. No. 17/045,406
Filed by DR. REDDY'S LABORATORIES LIMITED, Hyderabad (IN)
PCT Filed Apr. 10, 2019, PCT No. PCT/IN2019/050293
§ 371(c)(1), (2) Date Oct. 5, 2020,
PCT Pub. No. WO2019/198101, PCT Pub. Date Oct. 17, 2019.
Claims priority of application No. 201841013647 (IN), filed on Apr. 10, 2018.
Prior Publication US 2021/0401982 A1, Dec. 30, 2021
Int. Cl. A61K 9/19 (2006.01); A61K 39/395 (2006.01); A61K 47/22 (2006.01); A61K 47/26 (2006.01); C07K 16/28 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/19 (2013.01); A61K 47/22 (2013.01); A61K 47/26 (2013.01); C07K 16/2839 (2013.01); C07K 2317/24 (2013.01)] 4 Claims
OG exemplary drawing
 
1. A stable pharmaceutical formulation of vedolizumab comprising 60 mg/ml of vedolizumab, phosphate buffer at a concentration of 20 mM, 60 mg/ml sugar selected from sucrose or trehalose, and surfactant, wherein the formulation is devoid of free amino acid and is devoid of salt of amino acid, and wherein the amount of aggregate and fragment content is less than about 2% and less than about 1.5% respectively, when stored at 50° C. for two weeks.