Compositions and devices incorporating water-insoluble therapeutic agents and methods of the use thereof
Various aspects of the present invention provide compositions and implantable devices including a water-insoluble therapeutic agent solubilized in a matrix of a gallate-containing compound. Other aspects provide methods of manufacturing and using such compositions and devices.
1. A medical device comprising:
a base structure having a surface, and a coating layer on the surface comprising a water-insoluble therapeutic agent and a gallate-containing compound, wherein the gallate-containing compound is a dendrimer or a polymer comprising a gallate moiety, wherein the gallate-containing compound comprises a dendrimer.
2. The medical device of claim 1 , wherein the dendrimer is a polyamidoamine (PAMAM) dendrimer.
3. A film comprising:
a water-insoluble therapeutic agent and a gallate-containing compound, the gallate containing compound comprising tannic acid.
4. The film of claim 3 , wherein the water-insoluble therapeutic agent is dispersed in the gallate-containing compound.
5. The film of claim 4 , wherein the water-insoluble therapeutic agent is in crystalline form.
6. The film of claim 3 , wherein the film comprises a polyethylene glycol or glycerol, the polyethylene glycol being present at 10% to 20% w/w to the gallate-containing compound.
7. The film of claim 6 , wherein the polyethylene glycol is PEG 300.
8. The film of claim 7 , wherein the water-insoluble therapeutic agent is a taxane compound.
9. The film of claim 8 , wherein the taxane compound is paclitaxel or docetaxel.
10. The film of claim 3 , wherein the film is a layer of a medical device.
11. A medical device comprising:
a base structure having a surface, and a coating layer on the surface comprising a water-insoluble therapeutic agent and a gallate containing compound, wherein the gallate containing compound is a dendrimer.
12. The medical device of claim 11 , wherein the water-insoluble therapeutic agent is solubilized within a matrix of the gallate-containing compound.
13. The medical device of claim 11 , 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.
14. The medical device of claim 13 , wherein the water-insoluble therapeutic agent is a taxane compound.
15. The medical device of claim 14 , wherein the taxane compound is paclitaxel or docetaxel.
16. The medical device of claim 11 , wherein the dendrimer is covalently attached to a molecule comprising a gallate moiety.
17. The medical device of claim 16 , wherein the molecule is selected from epi gallo catechin gallate and tannic acid.
18. The medical device of claim 11 , wherein the coating layer is adhered directly on the surface of the base structure.
19. The medical device of claim 11 , wherein the coating layer is an outermost layer of the medical device.
20. The medical device of claim 11 , wherein the dendrimer is a polyamidoamine (PAMAM) dendrimer.