COATINGS WITH TUNABLE SOLUBILITY PROFILE FOR DRUG-COATED BALLOON

• US 20110144582A1
• Filed: 12/11/2009
• Published: 06/16/2011
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hossainy, Syed, Stankus, John, Trollsas, Mikael
• Granted Patent: US 8,480,620 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence

Abstract

A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Claims

1. A balloon for delivery of a therapeutic agent, the balloon comprising:

a body having an outer surface; and

a tunable coating disposed on at least a length of the outer surface, the tunable coating including a first therapeutic agent and a first excipient having a first dissolution rate, and a second therapeutic agent and a second excipient having a second dissolution rate different from the first dissolution rate to define a tunable solubility.

2. The balloon of claim 1, wherein the first therapeutic agent is different than the second therapeutic agent.

3. The balloon of claim 1, wherein the first excipient is a polymer having a molecular weight of less than about 35 kDalton.

4. The balloon of claim 1, wherein the second excipient is a polymer having a molecular weight greater than about 100 kDalton.

5. The balloon of claim 3, wherein the first excipient is polyvinylpyrrolidone or polyethylene glycol.

6. The balloon of claim 4, wherein the second excipient is polyvinylpyrrolidone or polyethylene glycol.

7. The balloon of claim 1, wherein the first or second excipient is a biodegradable polymer.

8. The balloon of claim 7, wherein the biodegradable polymer is Poly(D, L-lactide-co-glycolide).

9. The balloon of claim 7, wherein the first and second therapeutic agents have the same chemical formula and further wherein the first excipient is Poly(D, L-lactide-co-glycolide) and the second excipient is Poly(L-lactide-co-ε

-caprolactone).

10. The balloon of claim 1, wherein the first or second excipient is a protein polymer.

11. The balloon of claim 1, wherein at least one of the first or second therapeutic agents is a cytostatic drug.

12. The balloon of claim 11, wherein the cytostatic drug is zotarolimus.

13. The balloon of claim 1, wherein both the first and second therapeutic agents are paclitaxel.

14. The balloon of claim 1, wherein both the first and second therapeutic agents are zotaroliums.

15. The balloon of claim 12, wherein the first therapeutic agent is sirolimus and the second therapeutic agent is zotarolimus.

16. The balloon of claim 1, wherein the coating includes a third therapeutic agent and a third excipient.

17. The balloon of claim 1, wherein the coating includes first and second layers adsorbed to the surface of the balloon.

18. The balloon of claim 17, wherein the first layer consists of the first therapeutic agent and first excipient and the second layer consists of the second therapeutic agent and the second excipient.

19. The balloon of claim 18, wherein the first and second layers each has a dissolution rate, the dissolution profile of the first layer being different than the dissolution profile of the second layer.

20. The balloon of claim 1, wherein at least one of the first or second excipients is a carboxylated aromatic compound.

21. The balloon of claim 1, wherein at least one of the first or second excipients is halogenated.

22. The balloon of claim 1, wherein at least one of the first or second excipients is alkylated.

23. The balloon of claim 1, wherein the first therapeutic agent is released from the coating, and the second therapeutic agent is released with the coating.

24. The balloon of claim 1, wherein at least one excipient is blended with a contrast agent.

25. The balloon of claim 24, wherein the contrast agent is Ultravist

26. The balloon of claim 1, wherein the balloon is free of a stent.

27. A balloon for delivery of a drug, the balloon comprising:

a body having an outer surface; and

a tunable coating disposed on at least a length of the outer surface, the tunable coating including a cytostatic drug and at least one excipient, the tunable coating having a dissolution rate of about 10 s to about 1 h.

28. The balloon of claim 27, wherein at least one excipient is blended with a contrast agent.

29. The balloon of claim 27, wherein the first excipient is a polymer having a molecular weight of less than about 35 kDalton.

30. The balloon of claim 27, wherein the second excipient is a polymer having a molecular weight greater than about 100 kDalton.

31. The balloon of claim 27, wherein the cytostatic drug is zotarolimus.

32. The balloon of claim 27, wherein the coating further includes a plasticizer.

33. The balloon of claim 32, wherein the plasticizer is glycerol.

34. The balloon of claim 27, wherein the dissolution rate is about 10 seconds to 10 minutes.

35. The balloon of claim 27, wherein the excipient is hydrophilic.

36. The balloon of claim 35, wherein the excipient is polyvinylpyrrolidone.

37. A balloon for delivery of a drug, the balloon comprising

a body having an outer surface;

and

a tunable coating disposed on at least a length of the outer surface, the tunable coating including a cytostatic drug and at least one excipient, wherein the cytostatic drug to excipient weight ratio is from about 20;

1 to about 1;

20.

38. The balloon of claim 37, wherein the cytostatic drug to excipient weight ratio is from about 2:

1 to about 1;

2.

39. The balloon of claim 37, wherein the cytostatic drug is zotarolimus.

40. The balloon of claim 37, wherein the coating further includes a plasticizer.

41. The balloon of claim 40, wherein the excipient to plasticizer weight ratio is from about 20:

1 to about 1;

20

42. The balloon of claim 41, wherein the excipient to plasticizer weight ratio is from about 10:

1 to about 1;

1

43. The balloon of claim 40, wherein the plasticizer is glycerol.

44. The balloon of claim 37, wherein the at least one excipient is polyvinylpyrrolidone.

45. The balloon of claim 37, wherein the at least one excipient includes a blend of polyvinylpyrrolidone having two different molecular weights.

46. A balloon for delivery of a drug, the balloon comprising

a body having an outer surface;

and

a tunable coating disposed on at least a length of the outer surface, the tunable coating including a cytostatic drug and at least one polymeric excipient, wherein the at least one polymeric excipient has a polydispersity index from about 1.05 to about 10.

47. The balloon of claim 46, wherein the wherein the at least one polymeric excipient has a polydispersity index from about 1.05 to about 5.

48. The balloon of claim 46, wherein the cytostatic drug is zotarolimus.

49. The balloon of claim 46, wherein the coating further includes a plasticizer.

50. The balloon of claim 49, wherein the plasticizer is glycerol.

51. The balloon of claim 46, wherein the excipient is polyvinylpyrrolidone.