SELF-LUBRICATING PHARMACEUTICAL SYRINGE STOPPERS

• US 20130338606A1
• Filed: 08/16/2013
• Published: 12/19/2013
• 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, Rusinko, David M., Ramakrishnan, Indumathi, Dhanabalan, Anantharaman, Dubey, Mayank Kumar, Bley, Markus, Raman, Chandrashekar, Winkelbach, Hans Rafael
• Granted Patent: US 9,782,542 B2
• Time in Patent Office: Days
• US Class Current: 604/230
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• 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:

a lubricating additive, wherein 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;

a hard filler chosen from alumina, silica, titania, magnesia, zinc oxide, silicon carbide, silicon nitride, tungsten carbide, cubic boron nitride, aluminum nitride, or a combination of two or more thereof.

2. The component of claim 1 in the form of a plunger, piston, diaphragm, or valve disc for medical equipment.

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 5 to about 20% by weight of the polymer composition, and the hard filler is present in an amount of from about 2 to about 10% by weight of the polymer composition.

5. The component of claim 1, wherein the lubricating additive is present in an amount of from about 10 to about 15% by weight of the polymer composition, and the hard filler is present in an amount of from about 3 to about 5% by weight of the polymer composition.

6. The component of claim 1 further comprising a reinforcing additive.

7. The component of claim 6, wherein the reinforcing additive is chosen from carbon fiber, glass fiber, aramid fiber, a fibrous minerals, a vitreous fiber, a fumed metal oxide, or a combination of two or more thereof.

8. The component of claim 6, comprising the reinforcing additive in an amount of from about 0.1 to about 20% by weight of the polymer composition.

9. The composition of claim 1, wherein the lubricating additive comprises hexagonal boron nitride.

10. A pharmaceutical package assembly comprising:

a barrel having a body defining an interior surface; and

a plunger slideably disposed within the body, the plunger assembly including a component that comprises a polymer composition, the polymer composition comprising;

(a) a lubricating additive 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; and

(b) a hard filler, wherein the hard filler has a hardness greater than a hardness of the interior surface of the package assembly body.

11. The pharmaceutical package assembly of claim 10, wherein the hard filler is chosen from alumina, silica, titania, magnesia, zinc oxide, silicon carbide, silicon nitride, tungsten carbide, cubic boron nitride, aluminum nitride, or a combination of two or more thereof.

12. The pharmaceutical package assembly of claim 10, wherein the lubricating additive is present in an amount of from about 5 to about 20% by weight of the polymer composition, and the hard filler is present in an amount of from about 2 to about 10% by weight of the polymer composition.

13. The pharmaceutical package assembly of claim 10, further comprising a reinforcing additive.

14. The pharmaceutical package assembly of claim 10, wherein the lubricating additive comprises hexagonal boron nitride.

15. The pharmaceutical package assembly of claim 10, wherein the component is formed from the polymer composition.

16. The pharmaceutical package assembly of claim 10, wherein the component is coated with the polymer composition.

19. The pharmaceutical package assembly of claim 16, wherein the polymer composition comprises the high aspect filler in an amount of from about 1 vol % to about 70 vol %.

20. The pharmaceutical package assembly of claim 16, wherein the polymer composition has a permeability of from about 20 barrers to about 1000 barrers.

17. A pharmaceutical package assembly comprising a plunger comprising a lubricating polymeric composition comprising:

(a) a lubricating additive, 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, or any combination thereof; and

(b) a high aspect filler having an aspect ratio of from about 10 to about 300.

18. The pharmaceutical package assembly of claim 17, wherein the high aspect filler is chosen from a clay, an exfoliated clay, a graphite, an exfoliated graphite, graphene, exfoliated boron nitride, boron nitride nanosheets, a layered silicate, an aluminate, or a combination of two or more thereof.

21. A pharmaceutical package assembly comprising a plunger comprising a lubricating polymeric composition comprising a lubricating additive, 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, or any combination thereof, wherein the composition has a compression set of from about 3% to about 50%.

22. The pharmaceutical package assembly of claim 21 comprising a clay.

23. The pharmaceutical package assembly of claim 21 comprising a clay in an amount of from about 0.05 wt. % to about 10 wt. %.