Encapsulated drug compositions and methods of use thereof

• US 10,029,033 B2
• Filed: 04/25/2017
• Issued: 07/24/2018
• Est. Priority Date: 08/07/2014
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Gemborys, Colleen
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): TRUONG, QUANGLONG N
• Application Number:
  US15/496,466
• Publication Number:
  US 20170224878A1
• Time in Patent Office: 455 Days
• Field of Search: None
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• 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 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• 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
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Various aspects of the present disclosure provide compositions, coatings and implantable devices including a drug and an excipient. In certain embodiments the excipient and the drug are present at a weight ratio of between 10 to 1 and 1 to 10 drug to excipient. In certain other embodiments, the excipient and the drug form particles in which the drug is encapsulated by the excipient. Other aspects of the disclosure provide methods of manufacturing and using such compositions, coatings and implantable devices.

Claims

1. A medical device comprising:

a base structure having a surface, and

a coating on the surface comprising a drug and an excipient, wherein the drug and excipient are present at a weight ratio of between 10 to 1 and 1 to 10 drug to excipient, and wherein the excipient is selected from the group consisting of, epi gallo catechin gallate, tannic acid and epi catechin gallate, and wherein the drug is a restenosis-inhibiting agent.

2. The medical device of claim 1, wherein the excipient is selected from a group consisting of epi gallo catechin gallate and tannic acid.

3. The medical device of claim 2, wherein the excipient is tannic acid.

4. The medical device of claim 2, wherein the excipient is epi gallo catechin gallate.

5. The medical device of claim 1, wherein the coating consists essentially of the excipient and the drug.

6. The medical device of claim 1, wherein the restenosis-inhibiting agent is selected from the group consisting of an immunosuppressive agent, an antiproliferative agent, a microtubule stabilizing agent, a smooth muscle cell inhibitor and an inhibitor of the mammalian target of rapamycin.

7. The medical device of claim 1, wherein the drug is selected from the group consisting of sirolimus, pimecrolimus, tacrolimus, everolimus, zotarolimus, novolimus, myolimus, temsirolimus, deforolimus and biolimus.

8. The medical device of claim 1, wherein the drug is paclitaxel.

9. The medical device of claim 8, wherein the paclitaxel is selected from the group consisting of amorphous paclitaxel, dihydrate paclitaxel, anhydrous crystalline paclitaxel and a mixture of at least two thereof.

10. The medical device of claim 8, wherein the paclitaxel is present in an amorphous and a crystalline form.

11. The medical device of claim 1, wherein the coating is free of a polymer or non-polymer carrier matrix.

12. The medical device of claim 1, wherein the coating comprises less than 1 percentage by weight of a polymer or non-polymer carrier matrix.

13. The medical device of claim 1, wherein the medical device is a balloon.

14. The medical device of claim 1, wherein the medical device is a stent.

15. The medical device of claim 1, wherein the medical device is selected from the group consisting of a stent, a vascular stent, a ureteral stent, a catheter, a balloon, a balloon catheter, a stent graft, a wire guide, and a cannula.

16. The medical device of claim 1, wherein the drug is present in more than one polymorphic form.

17. The medical device of claim 1, wherein the excipient is present in an amount effective to increase a rate of release of the drug from the medical device when implanted in a patient.

18. The medical device of claim 1, wherein the drug is a water-insoluble drug.

19. A medical device comprising:

a balloon having an outside surface, and

a coating on the outside surface, the coating comprising paclitaxel and an excipient, wherein the paclitaxel and excipient are present at a weight ratio of between 10 to 1 and 1 to 10 paclitaxel to excipient, wherein the paclitaxel is present in an amorphous and a crystalline form, and wherein the excipient is selected from the group consisting of a epi gallo catechin gallate and tannic acid.