US 10,888,616 B2
Stabilized glucagon solutions
Hailiang Chen, San Diego, CA (US); Andrew Xian Chen, San Diego, CA (US); and Norman Keith Orida, San Diego, CA (US)
Assigned to LATITUDE PHARMACEUTICALS, INC., San Diego, CA (US)
Filed by Latitude Pharmaceuticals, Inc., San Diego, CA (US)
Filed on Feb. 22, 2018, as Appl. No. 15/902,337.
Application 15/902,337 is a continuation of application No. PCT/US2016/050110, filed on Sep. 2, 2016.
Claims priority of provisional application 62/214,831, filed on Sep. 4, 2015.
Prior Publication US 2018/0236079 A1, Aug. 23, 2018
Int. Cl. A61K 47/10 (2017.01); A61K 9/08 (2006.01); A61K 38/26 (2006.01); A61K 47/02 (2006.01); A61K 9/00 (2006.01); A61K 47/20 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61P 3/08 (2006.01); A61K 47/12 (2006.01)
CPC A61K 47/10 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 38/26 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61P 3/08 (2018.01)] 7 Claims
 
1. A ready-to-use, non-gelling, clear and one-phase solution composition, the composition comprising: glucagon having a concentration between 0.05 mg/mL and 5 mg/mL, water having a concentration between 3% and 5% w/v, an anti-gelling polyol comprising a combination of a propylene glycol and polyethylene glycol having a concentration between 60% and 97% w/v, an acid in sufficient quantity to adjust pH of the composition to a pH between 2 and 4, a stabilizing-salt selected from the group consisting of sodium chloride, calcium chloride, sodium acetate or a combination thereof, having a concentration between 0.5% and 3% w/v, an antioxidant selected from the group consisting of methionine, EDTA or a combination thereof having a concentration between 0.01% and 1% w/v, and optionally ethanol as a viscosity-reducer, wherein the clear and one-phase composition is free from cationic surfactants or a phospholipid and retains no less than 65% of the initial glucagon concentration after 24-month storage at 2-8° C.