Pharmaceutical elastomeric coating

• US 5,000,994 A
• Filed: 01/30/1989
• Issued: 03/19/1991
• Est. Priority Date: 04/13/1987
• Status: Expired due to Term

• Current Assignee: West Pharmaceutical Services Incorporated
• Original Assignee: West Corporation
• Inventors: Curry, Wayne T., Romberg, Val G., Kiang, Patty H.
• Primary Examiner(s): Lesmes, George F.
• Assistant Examiner(s): Brown, Christopher
• Application Number:
  US07/303,824
• Time in Patent Office: 778 Days
• Field of Search: 215/364, 220/19, 220/DIG. 19, 428/36.8, 428/494, 428/495, 428/519, 428/521, 528/396
• US Class Current: 428/36.8
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: B65D 2539/003 provided with sealing flanges or ribs
• CPC Class Codes: B65D 2539/008 with coatings or coverings
• CPC Class Codes: B65D 39/0011 from natural or synthetic cork, e.g. for wine bottles or the like
• CPC Class Codes: B65D 39/0058 from natural or synthetic cork, e.g. for wine bottles or the like
• CPC Class Codes: B65D 39/007 Plastic cap-shaped hollow plugs
• CPC Class Codes: B65D 39/0076 Plastic closures other than those covered by groups B65D39/0058 - B65D39/007
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: C08J 2321/00 Characterised by the use of unspecified rubbers
• CPC Class Codes: C08J 2465/00 Characterised by the use of macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain C08J2407/00 - C08J2457/00, C08J2461/00 take precedence; Derivatives of such polymers
• CPC Class Codes: C08J 7/0427 with only one layer of a composition containing a polymer binder with more layers C08J7/042
• CPC Class Codes: C08J 7/046 Forming abrasion-resistant coatings; Forming surface-hardening coatings
• CPC Class Codes: C09D 165/04 Polyxylylenes
• CPC Class Codes: Y10S 220/19 Rubber plugs and caps
• CPC Class Codes: Y10T 428/1386 Natural or synthetic rubber or rubber-like compound containing
• CPC Class Codes: Y10T 428/31833 Next to aldehyde or ketone condensation product or addition polymer from unsaturated monomers
• CPC Class Codes: Y10T 428/31837 Including polyene monomers
• CPC Class Codes: Y10T 428/31924 Including polyene monomers
• CPC Class Codes: Y10T 428/31931 Polyene monomer-containing

Abstract

An elastomeric member for use with a container and in contact with pharmaceutically pure contents therein. The elastomeric member has an elastomeric base and a continuous polyparaxylylene coating on the base. The coating ranges from about 0.1 microns to about 2.0 microns in thickness. The closure member has a coefficient of friction of less than 1.0 and is capable of substantially preventing metal extraction from said elastomers.

Claims

1. An elastomeric member for use with a container and in contact with pharmaceutically pure contents therein, comprising an elastomeric base and continuous polyparaxylylene coating on said base to reduce the coefficient of friction of said member to less than 1.0 and substantially prevent metal ion extractions from said base, said coating ranging from about 0.1 microns to about 2.0 microns in thickness.

2. The product of claim 1, wherein said coefficient of friction is less than 0.5.

3. The product of claim 1, wherein said extraction is at least 50 fold less calcium ion at 1 hour of autoclaving in 1 molar hydrochloric acid than an uncoated member.

4. The product of claim 1, wherein said extraction is at least 50 fold less aluminum in 1 hour of autoclaving in 1 molar hydrochloric acid than an uncoated member.

5. The product of claim 1, wherein said extraction is at least 50 fold less zinc at 1 hour autoclaving in 1 molar hydrochloric acid than an uncoated member.

6. The product of claim 1, which further includes a container with pharmaceutically pure contents therein.

7. The product of claim 1, wherein said member is selected from plunger tips, sleeve stoppers, seals, flashback bulbs tops and baby bottle nipples.

8. A baby bottle nipple formed from an elastomeric member, comprising an elastomeric base and a continuous polyparaxylylene coating on said base to substantially prevent metal ion extraction from said base, said coating increasing the tensile strength over an uncoated base without increasing the hardness, said coating ranging from about 0.1 microns to about 2.0 microns in thickness.

9. The bottle nipple of claim 8, wherein said coating ranges from about 0.2 microns to about 2.0 microns.

10. An elastomeric member for use with a container and in contact with pharmaceutically pure contents therein, comprising an elastomeric base and continuous polyparaxylylene coating on said base to reduce the coefficient of friction of said member to less than 1.0 and substantially prevent metal ion extractions from said base, said coating ranging from about 0.2 microns to about 2.0 microns in thickness.

11. The product of claim 10, wherein said coefficient of friction is less than 0.5.

12. The product of claim 10, wherein said extraction is at least 50 fold less calcium ion at 1 hour of autoclaving in 1 molar hydrochloric acid than an uncoated member.

13. The product of claim 10, wherein said extraction is at least 50 fold less aluminum in 1 hour of autoclaving in 1 molar hydrochloric acid than an uncoated member.

14. The product of claim 10, wherein said extraction is at least 50 fold less zinc at 1 hour autoclaving in 1 molar hydrochloric acid than an uncoated member.

15. The product of claim 10, which further includes a container with pharmaceutically pure contents therein.

16. The product of claim 10, wherein said member is selected from plunger tips, sleeve stoppers, seals, flashback bulbs tops and baby bottle nipples.