Antimicrobial composition for medical articles

• US 20050048124A1
• Filed: 08/25/2004
• Published: 03/03/2005
• Est. Priority Date: 08/26/2003
• Status: Active Grant

• Current Assignee: ICET Incorporated
• Original Assignee: ICET Incorporated
• Inventors: Sarangapani, Shantha
• Granted Patent: US 7,381,751 B2
• Time in Patent Office: Days
• US Class Current: 424/486
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/555 containing heavy metals, e.g. hemin, hematin, melarsoprol
• CPC Class Codes: A61K 33/38 Silver; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

An antimicrobial composition is formed from about 5 to about 25 wt % of an antimicrobial formulation and about 75 to about 95 wt % of a silicone resin. The antimicrobial formulation is formed from about 60 to about 95 wt % of an antimicrobial material, about 1 to about 30 wt % calcium chelator, about 0.001 to about 0.25 wt % pigment, and about 0.5 to about 3.5 wt % lubricant. The silicone resin may be a dispersion of about 40 to about 60 w/v % of an RTV silicone resin in a solvent, a liquid silicone resin, or a solid silicone resin. An antimicrobial coating may be formed on the surface of an article by applying an antimicrobial composition to the article and permitting the solvent to evaporate. It may also be formed by making a mixture of about 5 to about 12 wt % of an antimicrobial formulation and about 88 to about 95 wt % of a liquid or solid silicone resin and molding, overmolding, or extruding the article from the compounded mixture.

Claims

1. An antimicrobial composition comprising

(I) about 5 to about 25 wt % of an antimicrobial formulation that comprises

(A) about 40 to about 65 wt % of an antimicrobial material;

(B) about 1 to about 55 wt % calcium chelator;

(C) about 0.001 to'"'"'about 0.25 wt %-pigment; and

(D) about 0.5 to about 5 wt % lubricant; and

(II) about 75 to about 95 wt % of a silicone resin.

2. An antimicrobial composition according to claim 1 wherein said antimicrobial material is selected from the group consisting of silver, silver-copper, partially water soluble compounds of silver, silver pyrithione, zinc pyrithione, bismuth pyrithione, parabenzoic acid esters, and mixtures thereof.

3. An antimicrobial composition according to claim 1 wherein said calcium chelator is citric acid, ethylene diamine tetraacetic acid (acid form), or a mixture thereof.

4. An antimicrobial composition according to claim 1 wherein said pigment is copper phthalocyanine.

5. An antimicrobial composition according to claim 1 wherein said lubricant is polyethylene oxide.

6. An antimicrobial composition according to claim 1 that includes about 0.5 to about 4 wt % titanium dioxide.

7. An antimicrobial composition according to claim 1 wherein said silicone resin is a dispersion of about 40 to about 60 w/v %.

8. An antimicrobial composition according to claim 7 wherein said solvent is hexane.

9. A method of forming an antimicrobial coating on the surface of an article comprising applying an antimicrobial composition according to claim 7 to said article and permitting said solvent to evaporate.

10. A method according to claim 9 wherein said article is a catheter.

11. A method according to claim 10 wherein said catheter is made of silicone or is coated with silicone.

12. A coated article made according to the method of claim 9.

13. A method of forming an antimicrobial article comprising dipping a mandrel into a liquid antimicrobial composition according to claim 1, removing said mandrel from said antimicrobial composition, drying said antimicrobial composition on said mandrel to form an a coating on said mandrel, and removing said coating from said mandrel.

14. An antimicrobial composition according to claim 1 wherein said silicone resin is about 88 to about 95 wt % of said antimicrobial composition and is a liquid or solid silicone resin.

15. A method of forming an antimicrobial coating on the surface of an article comprising molding, overmolding, or extruding said article from an antimicrobial composition according to claim 14.

16. A method according to claim 15 wherein said article is a catheter.

17. A method according to claim 15 wherein said resin composition comprises a silicone resin.

18. A coated article made according to the method of claim 15.

19. An antimicrobial composition comprising

(I) about 5 to about 25 wt % of an antimicrobial formulation that comprises

(A) about 15 to about 25 wt % of silver, silver-copper, a partially water soluble silver salt, or mixtures thereof and about 25 to about 45 wt % of parabenzoic acid esters;

(B) about 20 to about 25 wt % citric acid and about 20 to about 25 wt % ethylene diamine tetraacetic acid (acid form);

(C) about 0.1 to about 0.25 wt % copper phthalocyanine;

(D) about 4 to about 5 wt % lubricant; and

(E) about 0 to about 4 wt % titanium dioxide; and

(II) about 75 to about 95 wt % of a dispersion of about 40 to about 60 w/v % of an RTV silicone in a solvent.

20. A method of forming an antimicrobial coating on the surface of a catheter comprising applying an antimicrobial composition according to claim 19 to said catheter and permitting said solvent to evaporate.

21. A catheter made according to the method of claim 20.

22. An antimicrobial composition suitable for extrusion or molding an article comprising

(I) about 5 to about 12 wt % of an antimicrobial formulation that comprises

(A) about 35 to about 50 wt % of an antimicrobial material;

(B) about 20 to about 25 wt % calcium chelator;

(C) about 0.005 to about 0.01 wt % pigment;

(D) about 2 to about 5 wt % polyethylene oxide; and

(E) about 0 to about 4 wt % titanium dioxide; and

(II) about 88 to about 95 wt % of a liquid or solid silicone resin.

23. A method of making a catheter comprising extruding a tube from the antimicrobial composition of claim 22.

24. A catheter made from the antimicrobial composition of claim 22.