Claims for Patent: 12,295,932

Summary for Patent: 12,295,932

Title:	Succinylcholine chloride prefilled syringe
Abstract:	Prefilled syringes containing a succinylcholine chloride composition, where the prefilled syringes comprise a syringe barrel and a syringe tip comprising cyclic olefin monopolymer (“COP”) or cyclic olefin copolymer (“COC”). The syringes can also comprise a luer adapter integral with the syringe tip, where the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. The succinylcholine chloride compositions include succinylcholine chloride, a tonicity agent and one or more pH adjusters in an aqueous solution having a pH from about 3.0-4.5. The prefilled syringes containing the succinylcholine compositions are storage-stable for extended periods of time at a temperature of 2-8° C., have acceptable physical parameters such as glide force and break force, and make safe and robust connections with needles and needleless luer adapter devices (“NLADs”).
Inventor(s):	Keith Jarmusik, Ragheb M. AbuRmaileh
Assignee:	Hikma Pharmaceuticals USA Inc
Application Number:	US17/517,808
Patent 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. 2. 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); wherein the succinylcholine chloride composition in the prefilled syringe contains not more than 6.5% by weight total impurities, not more than 0.2% by weight succinic acid, not more than 2.5% by weight choline chloride, and not more than 4.5% by weight succinylmonocholine chloride after storage at 2-8° C. for about 15 months, as determined by HPLC and/or Ion Chromatography (IC); 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. 3. The prefilled syringe of claim 1, wherein the succinylcholine chloride composition is present at a concentration of about 20 mg/ml. 4. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition is present in a volume of about 5 ml to about 10 ml. 5. The prefilled syringe of claim 1, wherein the syringe further comprises a luer adapter integral with the syringe tip, and wherein the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. 6. The prefilled syringe of claim 1, wherein the succinylcholine chloride composition has an initial osmolality of from about 260 to about 340 mOsm/kg. 7. The prefilled syringe of claim 1, wherein the sodium chloride is present in an amount of from about 4 mg/ml to about 7 mg/ml. 8. The prefilled syringe of claim 7, where the sodium chloride is present in an amount of about 4.5 mg/ml. 9. The prefilled syringe of claim 1, where the syringe has a glide force of less than 7 N and a break force of less than 20 N after storage at 2-8° C. for about 15 months, as determined by mechanical testing. 10. The prefilled syringe of claim 1, where the succinylcholine chloride composition is free of added preservatives. 11. The prefilled syringe of claim 1, wherein the succinylcholine chloride composition has an initial pH of from about 3.3 to about 3.8. 12. A prefilled syringe containing a premixed succinylcholine chloride composition, wherein the succinylcholine chloride composition comprises (a) about 20 mg/ml succinylcholine chloride; (b) a tonicity agent comprising sodium chloride present in an amount of about 4.5 mg/ml, (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, a syringe tip, and a luer adapter, where the syringe barrel, syringe tip and luer adapter are a single element 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 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. 13. A prefilled syringe containing a premixed succinylcholine chloride composition, wherein the succinylcholine chloride composition comprises (a) about 20 mg/ml succinylcholine chloride; (b) a tonicity agent comprising sodium chloride present in an amount of about 4.5 mg/ml, (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, a syringe tip, and a luer adapter, where the syringe barrel, syringe tip and luer adapter are a single element 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 after storage at 2-8° C. for about 15 months, as determined by High Performance Liquid Chromatography (HPLC); wherein the succinylcholine chloride composition in the prefilled syringe contains not more than about 6.5% by weight total impurities, not more than 0.2% by weight succinic acid, not more than 2.5% by weight choline chloride, and not more than 4.5% by weight succinylmonocholine chloride after storage at 2-8° C. for about 15 months, as determined by HPLC and/or Ion Chromatography (IC); 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. 14. A kit comprising: (a) the prefilled syringe of claim 12; and (b) tamper-evident flexible plastic packaging enveloping the prefilled syringe, wherein the packaging comprises polyester film. 15. The prefilled syringe of claim 1, 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 18 months, as determined by HPLC. 16. The prefilled syringe of claim 2, 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 18 months, as determined by HPLC and wherein the succinylcholine chloride composition contains not more than 6.5% by weight total impurities, not more than 0.2% by weight succinic acid, not more than 2.5% by weight choline chloride, and not more than 4.5% by weight succinylmonocholine chloride after storage at 2-8° C. for about 18 months, as determined by HPLC and/or IC. 17. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition is present at a concentration of about 20 mg/ml. 18. The prefilled syringe of claim 2, wherein the syringe further comprises a luer adapter integral with the syringe tip, and wherein the syringe barrel, syringe tip and luer adapter are a single element comprising COP or COC. 19. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition has an initial osmolality of from about 260 to about 340 mOsm/kg. 20. The prefilled syringe of claim 2, wherein the sodium chloride is present in an amount of from about 4 mg/ml to about 7 mg/ml. 21. The prefilled syringe of claim 2, where the succinylcholine chloride composition is free of added preservatives. 22. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition has an initial pH of from about 3.3 to about 3.8. 23. The prefilled syringe of claim 12, 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 18 months, as determined by HPLC. 24. The prefilled syringe of claim 13, 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 18 months, as determined by HPLC and wherein the succinylcholine chloride composition contains not more than 6.5% by weight total impurities, not more than 0.2% by weight succinic acid, not more than 2.5% by weight choline chloride, and not more than 4.5% by weight succinylmonocholine chloride after storage at 2-8° C. for about 18 months, as determined by HPLC and/or IC. 25. The prefilled syringe of claim 12, wherein the succinylcholine chloride composition has an initial pH of from about 3.3 to about 3.8. 26. The prefilled syringe of claim 25, wherein the succinylcholine chloride composition has a pH of from about 3.3 to about 3.8 after storage at 2-8° C. for about 15 months. 27. The prefilled syringe of claim 13, wherein the succinylcholine chloride composition has an initial pH of from about 3.3 to about 3.8. 28. The prefilled syringe of claim 27, wherein the succinylcholine chloride composition has a pH of from about 3.3 to about 3.8 after storage at 2-8° C. for about 15 months. 29. The prefilled syringe of claim 11, wherein the succinylcholine chloride composition has a pH of from about 3.3 to about 3.8 after storage at 2-8° C. for about 15 months. 30. The prefilled syringe of claim 22, wherein the succinylcholine chloride composition has a pH of from about 3.3 to about 3.8 after storage at 2-8° C. for about 15 months. 31. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition in the prefilled syringe does not contain leachables after storage at 2-8° C. for about 15 months. 32. The prefilled syringe of claim 2, wherein the succinylcholine chloride composition in the prefilled syringe is substantially free of leachables after storage at 2-8° C. for about 15 months.