	US 12,128,089 B2
	Stable liquid compositions of glucagon
Harish Govindaraja Setty Chinnari, Hyderabad (IN); Somashekhar Battini, Hyderabad (IN); Lourdu Chinnu Thippabattuni, Hyderabad (IN); Satheesh Balasubramanian, Hyderabad (IN); Sumitra Ashokkumar Pillai, Hyderabad (IN); and Praveen Kumar Subbappa, Princeton, NJ (US)
Assigned to SLAYBACK PHARMA LLC, Princeton, NJ (US)
Filed by Slayback Pharma LLC, Princeton, NJ (US)
Filed on May 25, 2023, as Appl. No. 18/202,103.
Claims priority of application No. 202241030296 (IN), filed on May 26, 2022.
Prior Publication US 2023/0381282 A1, Nov. 30, 2023
Int. Cl. A61K 38/26 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01)

CPC A61K 38/26 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01)]

20 Claims

1. An injectable solution, consisting of:

(a) a therapeutically effective amount of glucagon;

(b) at least one pharmaceutically acceptable solvent;

(d) at least one sugar; and

(e) optionally, at least one pH adjusting agent;

wherein the solution does not comprise a surfactant,

wherein said injectable solution is stable and ready-to-use,

wherein pH of said solution ranges from 3.8 to 4.2,

wherein the concentration of glucagon in the injectable solution is from about 2.5 mg/mL to about 10 mg/mL,

wherein the total impurities are present in an amount less than 10% w/w when stored at 25° C./60% RH for at least 12 months,

wherein a Glucagon (16-29) impurity is present in an amount less than 2% w/w when stored at 25° C./60% RH for at least 12 months,

wherein the injectable solution is suitable for administration for at least 12 months, and

wherein the injectable solution has not been reconstituted from a lyophilized powder prior to administration.