Low extractable, thermoplastic syringe and tip cap

• US 20050075611A1
• Filed: 04/05/2004
• Published: 04/07/2005
• Est. Priority Date: 10/01/2003
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hetzler, Kevin G., Groskopf, Roger
• Application Number:
  US10/818,206
• Publication Number:
  US 20050075611A1
• Time in Patent Office: Days
• US Class Current: 604/192
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001

Abstract

A prefilled syringe and syringe assembly having a syringe and a tip cap are produced from materials that do not interfere with the substance contained in the syringe and enable long term storage. The tip cap is made from a blend of a cyclic olefin polymer or copolymer and a thermoplastic elastomer. The thermoplastic elastomer is blended with the cyclic olefin copolymer in an amount so that the normally stiff and hard cyclic olefin copolymer is flexible and resilient to effectively seal and couple to the tip of a prefilled syringe.

Claims

1. A syringe tip cap comprising:

a body having a first open end, a closed second end and a bore having an internal dimension for mating with a tip of a syringe, said body being made from a polymer composition comprising a thermoplastic cyclic olefin polymer or copolymer and a thermoplastic elastomer and being sufficiently flexible to couple to and seal with the tip of a syringe.

2. The syringe tip cap of claim 1, wherein said thermoplastic cyclic olefin polymer or copolymer is a norbornene copolymer.

3. The syringe tip cap of claim 1, wherein said body is sterilizable by gamma radiation, ethylene oxide, autoclaving and combinations thereof without loss of flexibility and resilience and exhibits low extractables after sterilization.

4. The syringe tip cap of claim 1, wherein said body exhibits a residue upon ignition at 450°

C.-500°

C. of not more than 0.10 wt % based on the initial weight of said polymer composition.

5. The syringe tip cap of claim 3, wherein after sterilization said body exhibits low extractable levels as determined by 20 ml of a sample test solution having a residue of not more than 1.0 mg after evaporation and drying for 1 hour at 105°

C., where said sample test solution is obtained by autoclaving said polymer composition in 200 ml of water at 121°

C. for 1 hour.

6. The syringe tip cap of claim 1, wherein said polymer resin composition is sufficiently flexible and has elastomeric properties sufficient to couple with a frustoconical shaped syringe tip or a threaded syringe tip.

7. The syringe tip cap of claim 1, wherein said bore of said body has an axial length complementing a length of a cannula of said syringe, whereby a bottom end of said bore is able to seal an open outer end of said cannula, and where said polymer resin composition is sufficiently flexible and has elastomeric properties sufficient to couple with a frustoconical shaped syringe tip.

8. The syringe tip cap of claim 1, wherein said polymer composition comprises about 20 wt % to about 50 wt % of said thermoplastic elastomer.

9. The syringe tip cap of claim 1, wherein said polymer composition comprises about 30 wt % to about 40 wt % of said thermoplastic elastomer.

10. The syringe tip cap of claim 1, wherein said polymer composition consists essentially of norbornene cyclic olefin copolymer and said thermoplastic elastomer.

11. The syringe tip cap of claim 1, wherein said thermoplastic elastomer is a styrene-ethylene-ethylene-propylene-styrene block copolymer.

12. The syringe tip of claim 1, wherein said polymer composition comprises about 50 wt % to about 80 wt % of norbornene thermoplastic copolymer, and about 20 wt % to about 50 wt % of said thermoplastic elastomer.

13. A prefillable, low particle, low extractable syringe comprising:

a syringe assembly including a syringe barrel having a substance receiving chamber and a tip extending from a distal end of said syringe barrel and having a fluid passage extending through said tip, and a plunger received in said syringe barrel, and

a tip cap coupled to said tip for closing said tip, said tip cap being sufficiently flexible and resilient to be removably coupled to said tip and form a substantially fluidtight seal with said tip, said tip cap being made from an elastic and flexible polymer composition comprising a thermoplastic cyclic olefin polymer or copolymer and a thermoplastic elastomer.

14. The prefillable syringe of claim 13, wherein said syringe assembly and tip cap exhibit low extractables after sterilization by gamma radiation, ethylene oxide, autoclaving and combinations thereof as determined by extractables in solution as determined by a sample test solution having a residue of not more than 1.0 mg after evaporation and drying for 1 hour at 105°

C., where said sample solution is obtained by autoclaving said polymer composition in 200 ml of water at 121°

C. for 1 hour.

15. The prefillable syringe of claim 13, wherein said tip of said syringe has a substantially frustoconical shape or a threaded tip and where said tip cap is sufficiently flexible and resilient after sterilization to couple with said tip of said syringe and form said fluidtight seal.

16. The prefillable syringe of claim 13, wherein said syringe barrel has a luer collar surrounding said top of said syringe barrel and having internal threads, and where said tip cap has external threads complementing said internal threads of said luer collar for coupling said tip cap to said syringe barrel.

17. The prefillable syringe of claim 13, wherein said syringe includes a cannula extending from said tip for delivering a substance from said syringe, and where said tip cap has a channel with a closed end and an open end for coupling with said tip, said channel of said tip cap having an axial length complementing a length of said cannula whereby an end of said cannula penetrates a bottom end of said channel to seal an open end of said cannula.

18. The prefillable syringe of claim 13, wherein said tip cap exhibits a residue upon ignition at 450°

C.-500°

C. of not more than 0.10 wt % based on the initial weight of said polymer composition.

19. The prefillable syringe of claim 13, wherein said polymer composition comprises about 20 wt % to about 50 wt % of said thermoplastic elastomer.

20. The prefillable syringe of claim 13, wherein said polymer composition comprises about 30 wt % to about 40 wt % of said thermoplastic elastomer.

21. The prefillable syringe of claim 13, wherein said polymer composition consists essentially of said thermoplastic cyclic olefin polymer and said thermoplastic elastomer.

22. The prefillable syringe of claim 13, wherein said thermoplastic elastomer is a styrene-ethylene-ethylene-propylene-styrene block copolymer.

23. The prefillable syringe of claim 13, wherein said thermoplastic cyclic olefin is a norbomene copolymer.

24. A prefilled syringe assembly comprising:

a syringe barrel having a hollow body with a first open end and a tip with a bore extending into said hollow body;

a plunger received in and closing said first open end;

a solution or suspension contained within said syringe barrel to define said prefilled syringe; and

a tip cap removably coupled to said tip, said tip cap being made from a flexible and resilient polymer composition comprising a thermoplastic cyclic olefin polymer or copolymer and a thermoplastic elastomer.

25. The prefilled syringe assembly of claim 24, wherein said solution or suspension is a drug.

26. The prefilled syringe assembly of claim 24, wherein said solution or suspension remains free of contamination during prolonged storage.

27. The prefilled syringe assembly of claim 24, wherein said syringe assembly exhibits low extractable levels after sterilization by gamma radiation, ethylene oxide, autoclaving or combinations thereof as determined by a 20 ml sample test solution having a residue of not more than 1.0 mg after evaporation and drying for 1 hour at 105°

C., where said sample test solution is obtained by autoclaving said polymer composition in 200 ml of water at 121°

C. for 1 hour.

28. The prefilled syringe assembly of claim 24, wherein said solution or suspension is stable for at least six months at room temperature.

29. The prefilled syringe assembly of claim 24, wherein said tip cap exhibits a residue upon ignition at 450°

C.-500°

C. of not more than 0.10 wt % based on the initial weight of said polymer composition.

30. The prefilled syringe assembly of claim 24, wherein said thermoplastic cyclic olefin copolymer is a norbomene copolymer.

31. The prefilled syringe assembly of claim 24, wherein said prefilled syringe assembly is sterilizable by autoclaving and where said tip cap remains sufficiently flexible to seal said tip and exhibits low extractables after sterilization.

32. The prefilled syringe assembly of claim 31, wherein said prefilled syringe assembly is sterilizable by gamma radiation, ethylene oxide, autoclaving or combinations thereof and exhibits low extractables after sterilization.

33. The prefilled syringe assembly of claim 24, wherein said polymer composition comprises about 20 wt % to about 50 wt % of said thermoplastic elastomer based on the weight of said polymer composition.

34. The prefilled syringe assembly of claim 24, wherein said polymer composition comprises about 30 wt % to about 40 wt % of said thermoplastic elastomer based on the weight of said polymer composition.

35. The prefilled syringe assembly of claim 24, wherein said polymer composition consists essentially of said thermoplastic cyclic olefin copolymer and said thermoplastic elastomer.

36. The prefilled syringe assembly of claim 24, wherein said thermoplastic cyclic olefin is a norbomene copolymer and where said polymer composition consists essentially of said norbomene copolymer and said thermoplastic elastomer.