Self-lubricating pharmaceutical syringe stoppers

• US 8,530,536 B2
• Filed: 09/08/2011
• Issued: 09/10/2013
• Est. Priority Date: 10/01/2009
• Status: Active Grant

• Current Assignee: Momentive Performance Materials Incorporated (Momentive Performance Materials Holdings LLC)
• Original Assignee: Momentive Performance Materials Incorporated (Momentive Performance Materials Holdings LLC)
• Inventors: Conzone, Samuel D., Rusinko, David M., Raman, Chandrashekar, Ramakrishnan, Indumathi, Dhanabalan, Anantharaman, Dubey, Mayank Kumar, Dinkar, Sumi, Devi, Mayanglambam Rebika, Bley, Markus
• Primary Examiner(s): Seidleck, James J
• Assistant Examiner(s): Salamon, Peter A
• Application Number:
  US13/227,625
• Publication Number:
  US 20120065595A1
• Time in Patent Office: 733 Days
• Field of Search: 640/230, 523/75, 523/78
• US Class Current: 522/75
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: C10M 169/04 Mixtures of base-materials and additives
• CPC Class Codes: C10M 2201/041 Carbon; Graphite; Carbon black
• CPC Class Codes: C10M 2201/061 Carbides; Hydrides; Nitrides
• CPC Class Codes: C10M 2201/066 Molybdenum sulfide
• CPC Class Codes: C10M 2201/103 Clays; Mica; Zeolites
• CPC Class Codes: C10M 2201/105 Silica
• CPC Class Codes: C10M 2205/20 Natural rubber; Natural resins
• CPC Class Codes: C10M 2205/203 used as base material
• CPC Class Codes: C10M 2207/126 monocarboxylic
• CPC Class Codes: C10M 2207/28 Esters epoxidised esters C10M2207/24
• CPC Class Codes: C10M 2207/283 of polyhydroxy compounds
• CPC Class Codes: C10M 2213/062 Polytetrafluoroethylene [PTFE]
• CPC Class Codes: C10M 2215/08 Amides
• CPC Class Codes: C10M 2229/02 Unspecified siloxanes; Silicones
• CPC Class Codes: C10M 2229/025 used as base material
• CPC Class Codes: C10M 2229/04 Siloxanes with specific structure
• CPC Class Codes: C10M 2229/051 containing halogen
• CPC Class Codes: C10N 2030/06 Oiliness; Film-strength; Anti-wear; Resistance to extreme pressure
• CPC Class Codes: C10N 2040/50 : Medical uses

Abstract

In one aspect, a self-lubricating component is provided for a pharmaceutical packaging assembly. The self-lubricating component comprises a polymer composition and an effective amount of a lubricating additive such as, for example, boron nitride. In another aspect, a pharmaceutical packaging assembly may be provided having a surface thereof coated with a lubricating composition comprising boron nitride. The pharmaceutical packaging composition may be, for example, a pre-filled syringe comprising a body (barrel) and a plunger assembly.

Claims

1. A self-lubricating component for a pharmaceutical packaging assembly comprising a polymer composition comprising an effective amount of lubricating additive, wherein the lubricating additive comprises hexagonal boron nitride and wherein the component is in the form of a plunger, piston, diaphragm, or valve disc for medical equipment.

2. The component of claim 1 where the lubricating additive further comprises zinc stearate, oleamide, erucamide, pentaerythitol stearate or any salt, ester or amide of a fatty acid.

3. The component of claim 1, wherein the lubricating additive is present in an amount of from about 0.1 to about 50% by weight of the polymer composition.

4. The component of claim 1, wherein the lubricating additive is present in an amount of from about 3 to about 20% by weight of the polymer composition.

5. The component of claim 1, wherein the lubricating additive is present in an amount of from about 5 to about 10% by weight of the polymer composition.

17. The component of claim 1, wherein the lubricating additive further comprises one or more of:

boron nitride, graphite, molybdenum disulfide, talc, mica, colloidal silica, fumed silica, high molecular weight silicone gum, Reimer'"'"'s salt, siloxane particles, a salt, ester, or amide of a fatty acid, vinylfluoro silicones, D4 or any combination of two or more thereof.

6. A pharmaceutical package assembly comprising a barrel having an interior surface coated with a lubricating polymeric composition comprising a lubricating additive, wherein the lubricating additive comprises hexagonal boron nitride.

7. The pharmaceutical package assembly of claim 6, wherein the lubricating additive is present in an amount of from about 3 to about 20% by weight of the polymer composition.

8. The pharmaceutical package assembly of claim 6, wherein the lubricating additive is present in an amount of from about 5 to about 10% by weight of the polymer composition.

9. The pharmaceutical package assembly of claim 6 further comprising a plunger.

10. The pharmaceutical package assembly of claim 9, wherein the plunger is a self-lubricating component comprising a polymer composition comprising an effective amount of lubricating additive.

11. The pharmaceutical package assembly of claim 10, where the lubricating additive comprises one or more of:

boron nitride, graphite, molybdenum disulfide, talc, mica, colloidal silica, fumed silica, high molecular weight silicone gum, Reimer'"'"'s salt, siloxane particles, vinylfluoro silicones, D4, a salt, ester, or amide of a fatty acid, or any combination of two or more thereof.

12. The pharmaceutical package assembly of claim 9, wherein at least a portion of a surface of the plunger is coated with a lubricating polymeric composition comprising a lubricating additive.

18. The pharmaceutical package assembly of claim 6, wherein the lubricating additive is chosen from one or more of:

boron nitride, graphite, molybdenum disulfide, talc, mica, colloidal silica, fumed silica, high molecular weight silicone gum, Reimer'"'"'s salt, siloxane particles, a salt, ester, or amide of a fatty acid, vinylfluoro silicones, D4 or any combination of two or more thereof.

13. A pharmaceutical package assembly comprising a plunger having at least part of its surface coated with a lubricating polymeric composition comprising a lubricating additive, where the lubricating additive comprises hexagonal boron nitride.

14. The package assembly of claim 13, wherein the lubricating additive is present in an amount of from about 0.1 to about 50% by weight of the polymer composition.

15. The package assembly of claim 13, wherein the lubricating additive is present in an amount of from about 3 to about 20% by weight of the polymer composition.

16. The package assembly of claim 13, wherein the lubricating additive is present in an amount of from about 5 to about 10% by weight of the polymer composition.

19. The pharmaceutical package assembly of claim 13, wherein the lubricating additive is chosen from one or more of:

boron nitride, graphite, molybdenum disulfide, talc, mica, colloidal silica, fumed silica, high molecular weight silicone gum, Reimer'"'"'s salt, siloxane particles, a salt, ester, or amide of a fatty acid, vinylfluoro silicones, D4 or any combination of two or more thereof.