HYDROPHILIC COATINGS WITH TUNABLE COMPOSITION FOR DRUG COATED BALLOON

• US 20110144577A1
• Filed: 12/11/2009
• Published: 06/16/2011
• Est. Priority Date: 12/11/2009
• Status: Abandoned Application

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Pacetti, Stephen, Hossainy, Syed, Stankus, John, Trollsas, Mikael
• Application Number:
  US12/636,158
• Publication Number:
  US 20110144577A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• 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 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/141 Plasticizers
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A tunable coating formulation is described for a drug delivery balloon comprising a therapeutic agent, an excipient and a plasticizer. The tunable coating includes a first therapeutic agent and a first excipient, and can have 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. The plasticizer in the formulation has a weigh ratio of excipient to plasticizer below 1:0.1.

Claims

1. A therapeutic coating formulation for coating a medical balloon comprising:

a cytostatic therapeutic agent;

an excipient; and

a plasticizer, wherein the weight ratio of the excipient to plasticizer is below 1 to 0.1.

2. The coating formulation of claim 1, wherein the balloon exhibits improved flexibility when dry.

3. The coating formulation of claim 1, wherein the excipient is PVP.

4. The coating formulation of claim 1, wherein the plasticizer is selected from the group consisting of glycerol and propylene glycol.

5. The coating of claim 1, wherein the excipient is PVP, and the plasticizer is glycerol.

6. The coating of claim 1, wherein the cytostatic therapeutic agent is selected from the group consisting of everolimus, zotarolimus, rapamycin, biolimus, myolimus, novolimus, deforolimus, temsirolimus, paclitaxel and protaxel.

7. The coating of claim 1, wherein the cytostatic therapeutic agent and excipient have a weight ratio of greater than 1:

1.

8. The coating of claim 1, wherein the coating is applied to an outer surface of a medical balloon.

9. The coating of claim 8, wherein the coated medical balloon exhibits minimized drug loss during folding of the balloon.

10. The coating of claim 8, wherein the coated medical balloon exhibits improved drug recovery upon tracking the balloon through a lumen of a subject.

11. The coating formulation of claim 1, wherein the glass transition temperature of the hydrated coating is below 37°

C.

12. The coating formulation of claim 1, wherein the formulation provides for enhanced tissue uptake of the therapeutic agent upon balloon inflation.