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”).

We claim: 
     
         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 COP or COC, a plastic plunger rod, and a plunger rod stopper comprising bromobutyl rubber, chlorobutyl rubber, or an elastomer coated with an ETFE film; and   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 up to 15 months, as determined by HPLC.   
     
     
         2 . The prefilled syringe of  claim 1 , 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 up to 15 months, as determined by HPLC and/or IC. 
     
     
         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 up to 15 months, as determined by HPLC. 
     
     
         10 . The prefilled syringe of  claim 1 , where the succinylcholine 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 COP or COC; a plastic plunger rod; and a plunger rod stopper comprising bromobutyl rubber, chlorobutyl rubber, or an elastomer coated with an ETFE film; and   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 up to 15 months, as determined by HPLC.   
     
     
         13 . The prefilled syringe of  claim 12 , 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 up to 15 months, as determined by HPLC and/or IC. 
     
     
         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.