Coatings with crystallized active agent(s) and methods

1. A method for enhancing crystallization of an active agent in a coating disposed on a medical device, the method comprising:

selecting a solvent and a hydrophobic polymer, wherein the polymer and solvent form a true solution;

selecting a concentration of an active agent selected from the group consisting of paclitaxel, rapamycin, rapalogs, and derivatives thereof wherein the concentration of active agent is at least 80% of saturation in a composition comprising the solvent and about 1.0 to about 99.0 wt. % polymer;

combining the active agent, the polymer, and the solvent to form a coating composition having the selected concentration of the active agent;

applying the coating composition to the medical device; and evaporating the

solvent to form crystals of the active agent; wherein the active agent is at least 80% crystallized within one week of being disposed on the medical device.

2. The method of claim 1 , comprising selecting a concentration of the active agent that is at least 90% of saturation in a composition comprising the solvent and about 1.0 to about 99.0 wt. % polymer.

3. The method of claim 1 , comprising selecting a concentration of the active agent that is at least 95% of saturation in a composition comprising the solvent and about 1.0 to about 99.0 wt. % polymer.

4. The method of claim 1 , comprising selecting a concentration of the active agent that is at least 99% of saturation in a composition comprising the solvent and about 1.0 to about 99.0 wt. % polymer.

5. The method of claim 1 , the active agent comprising paclitaxel.

6. The method of claim 1 , the active agent comprising rapamycin.

7. The method of claim 1 , the solvent comprising a first solvent and a second solvent; wherein the active agent is soluble in the first and insoluble in the second solvent.

8. The method of claim 7 , the first solvent having a higher vapor pressure than the second solvent.

9. The method of claim 7 , the first solvent comprising THF and the second solvent comprising toluene.

10. The method of claim 1 , the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising poly(ethylene-co-vinyl acetate), wherein the second polymer component is selected from the group consisting of poly(ethylene-co-vinyl acetate) polymers having vinyl acetate concentrations of between about 10% and about 50% by weight.

11. The method of claim 1 , wherein the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising polybutadiene.

12. An elution control coating disposed on a medical device, the elution control coating comprising: a hydrophobic polymer, and an active agent selected from the group consisting of paclitaxel, rapamycin, rapalogs, and derivatives thereof, wherein the active agent is at least 80% crystallized within one week of being disposed on the medical device.

13. The elution control coating of claim 12 , wherein the active agent is at least 90% crystallized within one week of being disposed on the medical device.

14. The elution control coating of claim 12 , wherein the active agent is at least 95% crystallized within one week of being disposed on the medical device.

15. The elution control coating of claim 12 , wherein the active agent is at least 95% crystallized within one day of being disposed on the medical device.

16. The elution control coating of claim 12 , the active agent comprising paclitaxel.

17. The elution control coating of claim 12 , the active agent comprising rapamycin.

18. The elution control coating of claim 12 , the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising poly(ethylene-co-vinyl acetate).

19. The elution control coating of claim 12 , the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising poly(ethylene-co-vinyl acetate), wherein the second polymer component is selected from the group consisting of poly(ethylene-co-vinyl acetate) polymers having vinyl acetate concentrations of between about 10% and about 50% by weight.

20. The elution control coating of claim 12 , the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising polybutadiene.

21. A method for enhancing the formation of active agent crystals within a coating layer comprising:

combining a hydrophobic polymer, an active agent, and a solvent to form a coating solution comprising between 5 mg/ml and 200 mg/ml total solids concentration;

adjusting the concentration of the active agent in the coating solution to reach at least 80% of the active agent saturation point;

applying the coating solution to a device;

and evaporating the solvent to form crystals of the active agent; and

wherein, the active agent is selected from the group consisting of paclitaxel, rapamycin, rapalogs, and derivatives thereof; wherein the active agent is at least 80% crystallized within one week of being disposed on the device.

22. The method of claim 21 , wherein the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising poly(ethylene-co-vinyl acetate).

23. The method of claim 21 , wherein the polymer comprises a first polymer component comprising at least one poly(alkyl)(meth)acrylate and a second polymer component comprising polybutadiene.

24. The method of claim 21 , the solvent comprising a first solvent and a second solvent; wherein the active agent is soluble in the first solvent and insoluble in the second solvent.

25. The method of claim 24 , the first solvent having a higher vapor pressure than the second solvent.

26. The method of claim 24 , the first solvent comprising THF and the second solvent comprising toluene.