EXPANDABLE DEVICES COATED WITH A RAPAMYCIN COMPOSITION
Medical devices may be utilized for local and regional therapeutic agent delivery. These therapeutic agents or compounds may reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including restenosis, vulnerable plaque, and atherosclerosis in type 2 diabetic patients.
1 . A medical device comprising:
an expandable member having a first diameter for insertion into a vessel and a second diameter for making contact with the vessel walls; and
a non-aqueous formulation of a rapamycin, including synthetic and semi-synthetic analogs thereof, affixed to and dried onto at least a portion of the surface of the expandable member, the dried, non-aqueous liquid formulation comprising a rapamycin, in a therapeutic dosage in the range of up to ten micrograms per square millimeter of expandable member surface area, an antioxidant in an amount of up to 5 percent by weight relative to the amount of rapamycin, a film forming agent in a pharmaceutically acceptable range of between 0.05 percent to about 20 percent by weight relative to the amount of rapamycin, and substantially no volatile, non-aqueous solvent.
2 . The medical device according to claim 1 , wherein the expandable member comprises a balloon.
3 . The medical device according to claim 2 , further comprising a stent positioned over the balloon.
4 . The medical device according to claim 1 , wherein the antioxidant comprises butylated hydroxyl toluene.
5 . The medical device according to claim 1 , wherein the film forming agent comprises polyvinyl pyrrolidone.
6 . The medical device according to claim 1 , wherein the rapamycin comprises sirolimus.
7 . A non-aqueous formulation of a rapamycin, including synthetic and semi synthetic analogs thereof, comprising rapamycin in a therapeutic dosage range, an antioxidant in an amount of up to 5 percent by weight relative to the amount of rapamycin, a film forming agent in a pharmaceutically acceptable range of between 0.05 percent to about 20 percent by weight relative to the amount of rapamycin.
8 . The non-aqueous formulation of a rapamycin according to claim 7 , wherein the antioxidant comprises butylated hydroxyl toluene.
9 . The non-aqueous formulation of a rapamycin according to claim 7 , wherein the film forming agent comprises polyvinyl pyrrolidone.
10 . The non-aqueous formulation of a rapamycin according to claim 7 , wherein the rapamycin comprises sirolimus.
11 . The non-aqueous formulation of a rapamycin according to claim 7 , further comprising a volatile, non-aqueous solvent.
12 . The non-aqueous formulation of a rapamycin according to claim 11 , wherein the volatile, non-aqueous solvent comprises ethanol.