Permeabilizing reagents to increase drug delivery and a method of local delivery

• US 7,014,861 B2
• Filed: 10/24/2003
• Issued: 03/21/2006
• Est. Priority Date: 11/30/2001
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Roorda, Wouter E., Bhat, Vinayak D., Consigny, Paul M.
• Primary Examiner(s): Azpuru, Carlos A.
• Application Number:
  US10/693,047
• Publication Number:
  US 20040086550A1
• Time in Patent Office: 879 Days
• Field of Search: 424/423
• US Class Current: 424/423
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A composition and a method for increasing the permeability of membrane junctions or cell membranes for delivery of a drug to target tissues are disclosed. Also disclosed are methods and devices for local drug delivery.

Claims

1. A method of delivering a drug through a membrane junction or a cell membrane comprising:

delivering a permeabilizing reagent to a membrane junction or a cell membrane in a concentration sufficient to increase the permeability of the membrane junction or cell membrane; and

delivering a drug to the membrane junction or cell membrane, wherein the drug travels through the membrane junction or cell membrane.

2. The method of claim 1, wherein the permeabilizing reagent is delivered by a stent and/or a catheter.

3. The method of claim 1, wherein the drug is delivered by a stent and/or a catheter.

4. The method of claim 1, wherein the permeabilizing reagent is a solution including a solute selected from the group consisting of glucose, mannose, maltose, dextrose, fructose, sodium chloride, sodium citrate, sodium phosphate, polyethylene glycol, polyvinyl pyrrolidone and amino acids.

5. The method of claim 1, wherein the permeabilizing reagent is selected from the group consisting of iminodiacetic acid, nitriloacetic acid, ethylenediaminomonoacetic acid, ethylenediaminodiacetic acid, ethylenediaminotetraacetic acid, sodium taurodihydrofusidate, sodium salicylate, sodium caprate, sodium glycocholate, cholylsarcosine, isopropyl myristate, partially hydrolyzed triglycerides, fatty-acid sugar derivatives, oleic acid derivatives, histamine, bradykinin and its conformational analogs, tumor necrosis factor alpha, nitroglycerine, sodium nitroprusside, diethylamine sodium, 3-morpholinosydnonimine, S-nitroso-N-acetyl-penicillamine, and vascular endothelial growth factor and combinations thereof.

48. The method of claim 1, wherein the permeabilizing reagent is selected from the group consisting of a hyperosmotic solution, a calcium ion chelator, a surfactant, and a receptor-mediated permeabilizing reagent.

6. A method of local drug delivery, comprising:

locally applying a permeabilizing reagent to a selected area of a body tissueto increase the permeability of a cellular barrier; and

locally applying a drug to the body tissue.

7. The method of claim 6, wherein the permeabilizing reagent is applied before or concomitantly with the drug.

8. The method of claim 6, wherein the local application of the permeabilizing reagent and the drug are via a stent.

9. The method of claim 6, wherein the permeabilizing reagent is selected from the group consisting of a hyperosmotic solution, a calcium ion chelator, a surfactant, and a receptor-mediated permeabilizing reagent.

10. The method of claim 6, additionally including applying a P-glycoprotein system blocker.

11. The method of claim 10, wherein the application of The P-glycoprotein system blocker follows application of the permeabilizing reagent.

12. The method of claim 10, wherein the P-glycoprotein system blocker is selected from the group consisting of Pluronic P-85®

, verapamil, disulfiram and antisense oligonucleotide complementary to a messenger RNA encoding P-glycoprotein and combinations thereof.

13. The method of claim 6, wherein the drug is selected from the group consisting of antineoplastic, antimitotic, antiflammatory, antiplatelet, antiallergic, anticoagulant, antifibrin, antithrombin, antiproliferative, antioxidant, antimigratory, antiextracellular matrix deposition, pro-apoptotic, nitric oxide donor, pro-angiogenic, and pro-arteriogenic substances and combinations thereof.

49. The method of claim 6, wherein the local application of the permeabilizing reagent is via a catheter and the local application of the drug is via a stent.

14. A method of delivering a drug through a membrane junction or a cell membrane comprising:

delivering a hyperosmotic solution, a calcium ion chelator, a surfactant, and/or a receptor-mediated permeabilizing reagent to a membrane junction or a cell membrane in a concentration sufficient to increase the permeability of the membrane junction or cell membrane; and

delivering a drug to the membrane junction or cell membrane, wherein the drug travels through the membrane junction or cell membrane.

15. A method of local drug delivery, comprising:

(a) locally applying a hyperosmotic solution, a calcium ion chelator, a surfactant, and/or a receptor-mediated permeabilizing reagent to a selected area of a body tissue to increase the permeability of a cellular barrier; and

(b) locally applying a drug to the body tissue.

50. The method of claim 15, wherein steps (a) and (b) are performed via a stent.

51. The method of claim 15, wherein step (a) is performed via a catheter and step (b) is performed via a stent.

16. A method of local drug delivery, comprising:

locally applying a P-glycoprotein system blocker to a selected area of a body tissue; and

locally applying a drug to the body tissue.

17. The method of claim 16, further comprising locally applying a permeabilizing reagent to the body tissue.

18. The method of claim 17, wherein the permeabilizing reagent is applied before the P-glycoprotein system blocker.

19. The method of claim 17, wherein the permeabilizing reagent is selected from the group consisting of a hyperosmotic solution, a calcium ion chelator, a surfactant, and a receptor-mediated permeabilizing reagent.

20. The method of claim 16, wherein the P-glycoprotein system blocker is selected from the group consisting of Pluronic P-85®

, verapamil, disulfiram and antisense oligonucleotide complementary to a messenger RNA encoding P-glycoprotein and combinations thereof.

21. The method of claim 16, wherein the P-glycoprotein system blocker or the drug is carried by a stent.

52. The method of claim 16, wherein the local application of the P-glycoprotein system blocker and the local application of the drug are via a stent.

53. The method of claim 16, wherein the local application of the P-glycoprotein system blocker is via a catheter and the local application of the drug is via a stent.

22. A method of delivering a drug through a membrane junction or a cell membrane comprising:

delivering a hyperosmotic solution to a membrane junction or a cell membrane in a concentration sufficient to increase the permeability of the membrane junction or cell membrane; and

delivering a drug to the membrane junction or cell membrane, wherein the drug travels through the membrane junction or cell membrane.

23. The method of claim 22, wherein the hyperosmotic solution is delivered by a catheter.

24. The method of claim 22, wherein the drug is delivered by a stent and/or a catheter.

25. The method of claim 22, wherein the hyperosmotic solution includes a solute selected from the group consisting of glucose, mannose, maltose, dextrose, fructose, sodium chloride, sodium citrate, sodium phosphate, polyethylene glycol, polyvinyl pyrrolidone and amino acids.

26. A method of local drug delivery, comprising:

positioning a stent at a selected area of a body tissue, the stent carrying a permeabilizing reagent to increase the permeability of a cellular barrier; and

locally applying a drug to the body tissue.

27. The method of claim 26, wherein the permeabilizing reagent is selected from the group consisting of iminodiacetic acid, nitriloacetic acid, ethylenediaminomonoacetic acid, ethylenediaminodiacetic acid, ethylenediaminotetraacetic acid, sodium taurodihydrofusidate, sodium salicylate, sodium caprate, sodium glycocholate, cholylsarcosine, isopropyl myristate, partially hydrolyzed triglycerides, fatty-acid sugar derivatives, oleic acid derivatives, histamine, bradykinin and its conformational analogs, tumor necrosis, factor alpha, nitroglycerine, sodium nitroprusside, diethylamine sodium, 3-morpholinosydnonimine, S-nitroso-N-acetyl-penicillamine, and vascular endothelial growth factor and combinations thereof.

28. The method of claim 26, wherein the stent is positioned before or during the application of the drug.

29. The method of claim 26, wherein the local application of the drug is via a stent.

30. The method of claim 26, wherein the permeabilizing reagent is selected from the group consisting of a calcium ion chelator, a surfactant, and a receptor-mediated permeabilizing reagent.

31. The method of claim 26, wherein the stent additionally carries a P-glycoprotein system blocker.

32. The method of claim 31, wherein the P-glycoprotein system blocker is selected from the group consisting of Pluronic P-85®

, verapamil, disulfiram and antisense oligonucleotide complementary to a messenger RNA encoding P-glycoprotein and combinations thereof.

33. The method of claim 26, wherein the drug is selected from the group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, antiallergic, anticoagulant, antifibrin, antithrombin, antiproliferative, antioxidant, antimigratory, antiextracellular matrix deposition, pro-apoptotic, nitric oxide donor, pro-angiogenic, and pro-arteriogenic substances and combinations thereof.

34. The method of claim 26, wherein the permeabilizing reagent is carried by a polymeric coating on the stent.

35. The method of claim 26, wherein the stent additionally carries the drug.

36. The method of claim 35, wherein the stent carries the permeabilizing reagent and the drug in a coating, wherein the coating includes the permeabilizing reagent in a first layer and the drug in a second layer.

37. A method of local drug delivery, comprising:

positioning a stent at a selected area of a body tissue, the stent carrying a drug; and

locally applying a permeabilizing reagent to the body tissue to increase the permeability of a cellular barrier.

38. The method of claim 37, wherein the permeabilizing reagent is selected from the group consisting of iminodiacetic acid, nitriloacetic acid, ethylenediaminomonoacetic acid, ethylenediaminodiacetic acid, ethylenediaminotetraacetic acid, sodium taurodihydrofusidate, sodium salicylate, sodium caprate, sodium glycocholate, cholylsarcosine, isopropyl myristate, partially hydrolyzed triglycerides, fatty-acid sugar derivatives, oleic acid derivatives, histamine, bradykinin and its conformational analogs, tumor necrosis, factor alpha, nitroglycerine, sodium nitroprusside, diethylamine sodium, 3-morpholinosydnonimine, S-nitroso-N-acetyl-penicillamine, and vascular endothelial growth factor and combinations thereof.

39. The method of claim 37, wherein the permeabilizing reagent is applied before or during positioning of the stent.

40. The method of claim 37, wherein the local application of the permeabilizing reagent is via a stent.

41. The method of claim 37, wherein the permeabilizing reagent is selected from the group consisting of a hyperosmotic solution, a calcium ion chelator, a surfactant, and a receptor-mediated permeabilizing reagent.

42. The method of claim 37, wherein the stent additionally carries a P-glycoprotein system blocker.

43. The method of claim 42, wherein the P-glycoprotein system blocker is selected from the group consisting of Pluronic P-85®

, verapamil, disulfiram and antisense oligonucleotide complementary to a messenger RNA encoding P-glycoprotein and combinations thereof.

44. The method of claim 37, wherein the drug is selected from the group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, antiallergic, anticoagulant, antifibrin, antithrombin, antiproliferative, antioxidant, antimigratory, antiextracellular matrix deposition, pro-apoptotic, nitric oxide donor, pro-angiogenic, and pro-arteriogenic substances and combinations thereof.

45. The method of claim 37, wherein the drug is carried by a polymeric coating on the stent.

46. The method of claim 37, wherein the stent additionally carries the permeabilizing reagent.

47. The method of claim 46, wherein the stent carries the permeabilizing reagent and the drug in a coating, wherein the coating includes the permeabilizing reagent in a first layer and the drug in a second layer.

54. The method of claim 37, wherein the permeabilizing reagent is a solution including a solute selected from the group consisting of glucose, mannose, maltose, dextrose, fructose, sodium chloride, sodium citrate, sodium phosphate, polyethylene glycol, polyvinyl pyrrolidone and amino acids.