Composition, system, and method for modulating release kinetics in implantable drug delivery devices by modifying drug solubility

1. An implantable drug delivery device comprising: an implantable device configured to be implanted within tissue, lumens, or organs of the body; a beneficial agent provided in or on the implantable medical device for delivery to the tissue, lumen, or organ of the body to achieve a desired beneficial effect; wherein the beneficial agent is provided in two different forms, a first form having a higher solubility and a second form having a lower solubility, and wherein the two different forms are present in a proportion which is selected to achieve a desired release rate that is different from both a release rate of the first form alone and a release rate of the second form alone; wherein the beneficial agent is imatinib and the first form is a free-base form of imatinib and the second form is a salt form of imatinib.

2. The device of claim 1 , wherein the implantable device is microspheres, microparticles, nanospheres, or nanoparticles.

3. The device of claim 1 , wherein the implantable device is a metallic implant.

4. The device of claim 1 , wherein the implantable device is a stent.

5. The device of claim 1 , wherein beneficial agent is coated on the implantable device.

6. The device of claim 1 , wherein the beneficial agent contained in reservoirs in the implantable medical device.

7. The device of claim 6 , wherein the different forms of the beneficial agent are contained in different reservoirs.

8. The device of claim 6 , wherein the different forms of the beneficial agent are contained in the same reservoir.

9. The device of claim 1 , wherein the first form includes an inclusion complex and the second form includes no inclusion complex or less inclusion complex than the first form.

10. The device of claim 1 , wherein the first form includes a solubilization agent and the second form includes no solubilization agent or less solubilization agent.

11. A method of forming an implantable drug delivery device comprising: selecting an implantable device configured to be implanted within tissue, lumens, or organs of the body; providing a beneficial agent in two different forms, a first form having a higher solubility and a second form having a lower solubility; selecting a proportion of the two different forms to achieve a desired release rate; affixing the beneficial agent in the two different forms and in the selected proportion to the implantable device; wherein the beneficial agent is imatinib and the first form is a free-base form of imatinib and the second form is a salt form of imatinib.

12. The method of claim 11 , wherein the two different forms of the beneficial agent are mixed together before affixing to the implantable device.

13. The method of claim 11 , wherein the two different forms of the beneficial agent are maintained separate when affixed to the implantable device.

14. The method of claim 11 , wherein the implantable device is microspheres, microparticles, nanospheres, or nanoparticles.

15. The method of claim 11 , wherein the implantable device is a metallic implant.

16. The method of claim 11 , wherein the implantable device is a stent.

17. The method of claim 11 , wherein beneficial agent is coated on the implantable device.

18. The method of claim 11 , wherein the beneficial agent is contained in reservoirs in the implantable medical device.

19. The method of claim 11 , wherein the first form includes an inclusion complex and the second form includes no inclusion complex or less inclusion complex than the first form.

20. The method of claim 11 , wherein the first form includes a solubilization agent and the second form includes no solubilization agent or less solubilization agent.