Compositions and devices incorporating water-insoluble therapeutic agents and methods of the use thereof

1. A medical device comprising:

a base structure having a surface, and

a coating on the surface comprising a water-insoluble therapeutic agent solubilized within a matrix of gallate-containing compound, wherein the coating is free of a polymeric carrier and wherein the coating adheres directly to the base structure and forms an outermost surface of the medical device.

2. The medical device of claim 1 , wherein the coating is free of a non-polymer carrier modifying a rate of release of the therapeutic agent.

3. The medical device of claim 1 , wherein the gallate containing compound is selected from a group consisting of epi gallo catechin gallate, tannic acid and epi catechin gallate.

4. The medical device of claim 1 , wherein the gallate containing compound comprises a gallate substituted molecule selected from the group consisting of a dendrimer, a polymer, a macromolecule or a small molecule.

5. The medical device of claim 3 , wherein the gallate containing compound is epi gallo catechin gallate.

6. The medical device of claim 1 , wherein the gallate containing compound and the water-insoluble therapeutic agent are present at a weight ratio of between 30 to 1 and 500 to 1 gallate containing compound to water-insoluble therapeutic agent.

7. The medical device of claim 6 , wherein the water-insoluble therapeutic agent is contained within a matrix of the gallate containing compound and wherein the water-insoluble therapeutic agent and the gallate containing compound are present at a weight ratio of between 30 to 1 and 100 to 1 gallate containing compound to water-insoluble therapeutic agent.

8. The medical device of claim 1 , wherein the implantable medical device is an expandable balloon or a stent.

9. The medical device of claim 1 , wherein the medical device is selected from the group consisting of a stent, a vascular stent, a ureteral stent, a catheter, a balloon, a balloon catheter, a stent graft, a wire guide, and a cannula.

10. The medical device of claim 1 , wherein the water-insoluble therapeutic agent is an immunosuppressive agent, an antiproliferative agent, a microtubule stabilizing agent, a restenosis-inhibiting agent, or an inhibitor of the mammalian target of rapamycin.

11. The medical device of claim 10 , wherein the water-insoluble therapeutic agent is a taxane compound.

12. The medical device of claim 11 , wherein the taxane compound is paclitaxel or docetaxel.

13. The medical device of claim 12 , wherein the therapeutic agent is a macrolide immunosuppressive agent.

14. The medical device of claim 1 , wherein the coating consists essentially of the water-insoluble therapeutic agent and the gallate containing compound.

15. A medical device comprising:

a base structure comprising a balloon or a stent, and

a coating on the base structure comprising a gallate containing compound and a taxane agent, wherein the gallate containing compound and the taxane agent are present at a weight ratio of between 1 to 40 and 500 to 1 gallate containing compound to taxane agent wherein the coating is free of a polymeric carrier and wherein the coating adheres directly to the base structure and forms an outermost surface of the medical device.

16. The medical device of claim 15 , wherein taxane agent is paclitaxel or docetaxel.

17. The medical device of claim 1 , wherein the base structure is a balloon.

18. A medical device comprising:

a balloon, and

a coating on the balloon comprising a gallate containing compound and a taxane agent, wherein the taxane agent is solubilized within a matrix of the gallate containing compound, wherein the gallate containing compound and the taxane agent are present at a weight ratio of between 30 to 1 and 100 to 1 gallate containing compound to taxane agent, wherein the coating is free of a polymeric carrier and wherein the coating adheres directly to the balloon and forms an outermost surface of the medical device.