US 12,295,932 B2
Succinylcholine chloride prefilled syringe
Keith Jarmusik, Bedford, OH (US); and Ragheb M. AbuRmaileh, Bedford, OH (US)
Assigned to Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ (US)
Filed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ (US)
Filed on Nov. 3, 2021, as Appl. No. 17/517,808.
Application 17/517,808 is a continuation of application No. 17/517,259, filed on Nov. 2, 2021, abandoned.
Prior Publication US 2023/0132721 A1, May 4, 2023
Int. Cl. A61K 31/221 (2006.01); A61J 1/20 (2006.01); A61K 9/00 (2006.01); A61K 31/225 (2006.01); A61K 47/02 (2006.01); A61M 5/31 (2006.01); A61M 5/315 (2006.01); A61M 5/50 (2006.01); A61M 5/00 (2006.01)
CPC A61K 31/221 (2013.01) [A61J 1/2048 (2015.05); A61J 1/2096 (2013.01); A61K 9/0019 (2013.01); A61K 31/225 (2013.01); A61K 47/02 (2013.01); A61M 5/3129 (2013.01); A61M 5/3134 (2013.01); A61M 5/31505 (2013.01); A61M 5/5086 (2013.01); A61M 5/002 (2013.01)] 32 Claims
 
1. A prefilled syringe containing a premixed succinylcholine chloride composition,
wherein the succinylcholine chloride composition comprises (a) about 10 mg/ml to about 30 mg/ml succinylcholine chloride; (b) a tonicity agent comprising sodium chloride, (c) a pH adjuster comprising hydrochloric acid, sodium hydroxide, or a combination thereof, and (d) water for injection;
wherein the succinylcholine chloride composition has an initial pH of from about 3.0 to about 4.5;
wherein the syringe has a syringe barrel and a syringe tip comprising a cyclic olefin monopolymer (COP) or a cyclic olefin copolymer (COC), a plastic plunger rod, and a plunger rod stopper comprising bromobutyl rubber, chlorobutyl rubber, or an elastomer coated with a poly (ethylene tetrafluoroethylene) (ETFE) film;
wherein the succinylcholine chloride composition in the prefilled syringe contains at least 90% of the initial amount of succinylcholine chloride after storage at 2-8° C. for about 15 months, as determined by High Performance Liquid Chromatography (HPLC); and
wherein the succinylcholine chloride composition in the prefilled syringe does not contain leachables or is substantially free of leachables after storage at 2-8° C. for about 15 months.