US 11,752,097 B2
N-acetylcysteine 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 Jul. 5, 2022, as Appl. No. 17/857,587.
Application 17/857,587 is a division of application No. 17/177,797, filed on Feb. 17, 2021, granted, now 11,413,238.
Claims priority of provisional application 62/978,128, filed on Feb. 18, 2020.
Prior Publication US 2022/0331239 A1, Oct. 20, 2022
Int. Cl. A61K 9/00 (2006.01); A61K 47/26 (2006.01); A61K 47/02 (2006.01); A61K 31/19 (2006.01); A61J 1/10 (2006.01)
CPC A61K 9/0019 (2013.01) [A61K 31/19 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); A61J 1/10 (2013.01)] 8 Claims
 
1. A sterile and ready-to-administer N-acetylcysteine composition, comprising:
an aqueous solution containing N-acetylcysteine at a concentration suitable for direct administration via intravenous injection to a patient without dilution prior to administration;
wherein the composition has a pH of between 6.0 and 7.5 and comprises a chelating agent at a concentration of between 10 and 60 mcg/mL; and
wherein the ready-to-administer composition contains, after storage over at least three weeks at 80° C., equal or less than 7% total impurities generated from degradation of the N-acetylcysteine.