US 11,806,320 B2
Isoproterenol compositions and methods
Ronald Domalaon, Raritan, NJ (US); Jinjiang Li, Monmouth Junction, NJ (US); Tushar Hingorani, Bridgewater, NJ (US); and Kumaresh Soppimath, Skillman, NJ (US)
Assigned to ENDO VENTURES LIMITED, Dublin (IE)
Filed by ENDO VENTURES LIMITED, Dublin (IE)
Filed on Feb. 18, 2021, as Appl. No. 17/179,078.
Claims priority of provisional application 62/978,624, filed on Feb. 19, 2020.
Prior Publication US 2021/0259994 A1, Aug. 26, 2021
Int. Cl. A61K 31/137 (2006.01); A61K 9/08 (2006.01); A61K 47/54 (2017.01); A61J 1/14 (2023.01); A61L 2/00 (2006.01)
CPC A61K 31/137 (2013.01) [A61K 9/08 (2013.01); A61K 47/547 (2017.08); A61L 2/0017 (2013.01); A61J 1/14 (2013.01); A61L 2202/21 (2013.01)] 18 Claims
 
1. A storage stable sterile ready-to-administer pharmaceutical composition, comprising:
a buffered aqueous solution comprising isoproterenol at a concentration of between 1-10 mcg/mL;
wherein the buffered aqueous solution has a pH range of between 3.0 and 4.5 and wherein the buffer is a tartrate buffer and has a concentration of equal to or less than 10 mM;
wherein the solution further comprises ethylenediamine tetraacetic acid (EDTA) as a chelating agent at a concentration of about 5 mcg/mL and a tonicity agent;
wherein the ready-to-administer composition contains, after storage over at least three weeks at 60° C. in a container having a headspace that has not been flushed with an inert gas, equal to or less than 2.0% of total impurities formed from degradation of the isoproterenol, and
wherein the composition is formulated for intravenous administration and is antioxidant free.