Container and method for storing a pharmaceutical agent

• US 9,068,565 B2
• Filed: 05/03/2012
• Issued: 06/30/2015
• Est. Priority Date: 05/03/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Alarcon, Javier, Horvath, Joshua, Riggsbee, William, Kommireddy, Dinesh, Pettis, Ron J.
• Primary Examiner(s): PACKARD, BENJAMIN J
• Application Number:
  US13/463,509
• Publication Number:
  US 20130296235A1
• Time in Patent Office: 1,153 Days
• US Class Current: 1/1
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/2488 via rotation, e.g. threads or bayonet
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31585 performed by axially moving actuator, e.g. an injection button
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/18 characterised by the use of special additives
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: F04B 43/0072 of tubular flexible members
• CPC Class Codes: F04B 43/08 having tubular flexible members F04B43/12 takes precedence
• CPC Class Codes: F05C 2225/00 Synthetic polymers, e.g. plastics; Rubber
• CPC Class Codes: F05C 2231/00 Organic materials not otherwise provided for

Abstract

A container and method for storing a pharmaceutical agent are provided for enhancing the storage time. The storage time of the pharmaceutical agent is improved by reducing the loss of stabilizing agents in the pharmaceutical agent. The storage container is formed from a polyolefin that includes a stabilizing agent in an amount effective to reduce or inhibit the migration of stabilizing agents in the pharmaceutical agent. The polyolefin container is formed with a fatty acid amide such as erucamide for stabilizing insulin that contains m-cresol and/or phenol as stabilizing agents for the insulin. The fatty acid amide incorporated in the container inhibits and/or reduces the rate of migration of the m-cresol and/or phenol into the polyolefin to extend the storage life of the insulin. The container can be a syringe, such as a pre-filled syringe, a storage vial or the flow path of an infusion pump.

Claims

1. A storage apparatus for a pharmaceutical agent, said storage apparatus comprising:

a storage container formed from a polyolefin, including a fatty acid amide dispersed in said polyolefin; and

a pharmaceutical agent in said storage container and containing a phenolic stabilizing agent in an amount effective to stabilize said pharmaceutical agent;

said fatty acid amide being included in said polyolefin in an amount effective to reduce a rate of migration of said phenolic stabilizing agent from said pharmaceutical agent into said polyolefin.

2. The storage apparatus of claim 1, wherein

said storage container is a prefilled syringe.

3. The storage apparatus of claim 1, wherein

said storage container is a storage reservoir of an electro-mechanical infusion pump assembly.

4. The storage apparatus of claim 1, wherein

said storage container includes an outer layer and an inner layer, said inner layer being formed from said polyolefin containing said fatty acid amide.

5. The storage apparatus of claim 4, wherein

said container is flexible tubing.

6. The storage apparatus of claim 4, wherein

said container is a primary insulin reservoir of an insulin infusion device and where said pharmaceutical agent is insulin.

7. The storage apparatus of claim 1, wherein

said polyolefin is polypropylene and said fatty acid amide is erucamide.

8. The storage apparatus of claim 1, wherein

said polyolefin is selected from the group consisting of polypropylene, polyethylene and polypropylene/polyethylene blends.

9. The storage apparatus of claim 1, wherein

said polyolefin is a cyclic olefin copolymer.

10. The storage apparatus of claim 1, wherein

said fatty acid amide is selected from the group consisting of lauramide, myristamide, palmitamide, stearamide, behenamide, erucamide, montanamide, stearylerucamide, oleylpalmitamide, methylenebis(stearamide), ethylenebis(myristamide), ethylenebis(palmitamide) and ethylenebis(stearamide);

and where said stabilizing agent is m-cresol, phenol, or mixtures thereof.

26. The storage apparatus of claim 1, wherein

said fatty acid amide is included in said polyolefin in an amount of 0.02 to 2.0 wt %.

27. The storage apparatus of claim 1, wherein

said fatty acid amide is included in said polyolefin in an amount of 0.02 to 0.4 wt %.

11. A method of preserving a pharmaceutical agent comprising the step of:

containing and storing the pharmaceutical agent in a containment vessel formed of a polyolefin including a fatty acid amide, said pharmaceutical agent including a phenolic stabilizing agent in an amount effective to stabilize said pharmaceutical agent for prolonged storage, and said polyolefin includes said fatty acid amide in an amount effective to reduce the rate of migration of said stabilizing agent from said pharmaceutical agent into said polyolefin.

12. The method of claim 11, wherein

said pharmaceutical agent is insulin and said stabilizing agent is selected from the group consisting of m-cresol, phenol, and mixtures thereof.

13. The method of claim 11, wherein

said fatty acid amide is selected from the group consisting of lauramide, myristamide, palmitamide, stearamide, behenamide, erucamide, montanamide, stearylerucamide, oleylpalmitamide, methylenebis(stearamide), ethylenebis(myristamide), ethylenebis(palmitamide) and ethylenebis(stearamide).

14. The method of claim 11, wherein

said containment vessel is a reservoir of an electro-mechanical infusion pump.

15. The method of claim 14, wherein

said electro-mechanical infusion pump includes flexible tubing made from said polyolefin and fatty acid amide.

16. The method of claim 11, wherein

said containment vessel is a pre-filled syringe containing insulin.

17. The method of claim 11, wherein

said polyolefin is selected from the group consisting of polypropylene, ethylene and polypropylene/polyethylene blends.

18. The method of claim 11, wherein

said polyolefin is a cyclic olefin copolymer.

19. A method of inhibiting loss of a stabilizing agent from a pharmaceutical agent during storage, said method comprising the steps of:

introducing the pharmaceutical agent into and storing the pharmaceutical agent in a storage chamber formed from a polyolefin containing a fatty acid amide, said pharmaceutical agent including a phenolic stabilizing agent in an amount effective to stabilize said pharmaceutical agent, and said fatty acid amide is incorporated in said polyolefin in an amount effective to reduce the rate of migration of said stabilizing agent from said pharmaceutical agent into said polyolefin.

20. The method of claim 19, wherein

said pharmaceutical agent is insulin and said stabilizing agent is selected from the group consisting of m-cresol, phenol, and mixtures thereof.

21. The method of claim 20, wherein

said fatty acid amide is selected from the group consisting of lauramide, myristamide, palmitamide, stearamide, behenamide, erucamide, montanamide, stearylerucamide, oleylpalmitamide, methylenebis(stearamide), ethylenebis(myristamide), ethylenebis(palmitamide) and ethylenebis(stearamide).

22. The method of claim 19, wherein

said storage chamber is an electro-mechanical infusion device.

23. The method of claim 19, wherein

said storage chamber is a flexible tubing of said electro-mechanical infusion device.

24. The method of claim 23, wherein

said flexible tubing has an outer layer and an inner barrier layer in contact with said pharmaceutical agent, said inner barrier layer being formed from said polyolefin and fatty acid amide.

25. The method of claim 19, wherein

said pharmaceutical agent is insulin, said stabilizing agent is selected from the group consisting of m-cresol, phenol, and mixtures thereof, and said fatty acid amide is erucamide.

28. The method of claim 19, further comprising

adding said fatty acid amide to said polyolefin in an amount of 0.02 to 2.0 wt %.

29. The method of claim 19, further comprising

adding said fatty acid amide to said polyolefin in an amount of 0.02 to 0.4 wt %.

30. An insulin delivery device, comprising

a cartridge having an internal cavity and a plunger, said cartridge being formed from a polyolefin and a fatty acid amide, said fatty acid amide selected from the group consisting of lauramide, myristamide, palmitamide, stearamide, behenamide, erucamide, montanamide, stearylerucamide, oleylpalmitamide, methylenebis(stearamide), ethylenebis(myristamide), ethylenebis(palmitamide) and ethylenebis(stearamide);

and

an amount of insulin contained in said cartridge, said insulin containing a stabilizing agent selected from the group consisting of m-cresol, phenol, and mixtures thereof, said stabilizing agent being included in an amount effective to stabilize said insulin during storage;

said fatty acid amide being included in said polyolefin in an amount effective to inhibit migration of said stabilizing agent from said insulin into said polyolefin.