Drug formulations for coating medical devices

Abstract

The present invention relates to oil-based formulations of hydrophobic drugs for the uniform coating of medical devices such as vascular stents and balloons. Another aspect of the present invention is an intravascular medical device having an oil-based coating suitable for delivering a water-insoluble drug, comprising one or more of an anti-oxidant, an anti-inflammatory and an anti-restenotic agent.

What is claimed is:  
     
         1 . A formulation for coating a medical device with a hydrophobic therapeutic agent, comprising the hydrophobic therapeutic agent, a non-volatile oil-based solvent, and an amount of a volatile solvent sufficient to decrease the viscosity of the non-volatile oil-based solvent, such that the formulation is adapted to uniformly coat the medical device.  
     
     
         2 . The formulation of  claim 1 , wherein the hydrophobic therapeutic agent is a restenosis-inhibiting agent.  
     
     
         3 . The formulation of  claim 2 , wherein the hydrophobic restenosis-inhibiting agent is C6-ceramide.  
     
     
         4 . The formulation of  claim 1 , wherein the hydrophobic therapeutic agent is an anti-inflammatory agent.  
     
     
         5 . The formulation of  claim 1 , wherein the hydrophobic therapeutic agent is an anti-oxidant.  
     
     
         6 . The formulation of  claim 1 , wherein the non-volatile oil-based solvent comprises Vitamin E.  
     
     
         7 . The formulation of  claim 1 , wherein the volatile solvent comprises an alcohol.  
     
     
         8 . The formulation of  claim 7 , wherein said alcohol comprises ethanol or isopropanol.  
     
     
         9 . A pharmaceutical formulation, comprising C6-ceramide and Vitamin E.  
     
     
         10 . A medical device comprising a surface adapted to contact a vessel wall, wherein said surface has a coating comprising a hydrophobic therapeutic agent, and a non-volatile oil-based solvent in which said agent is dissolved.  
     
     
         11 . The medical device of  claim 10 , wherein said device is an intravascular balloon.  
     
     
         12 . The medical device of  claim 10 , wherein said device is an intravascular stent.  
     
     
         13 . The medical device of  claim 10 , wherein said oil-based solvent comprises Vitamin E.  
     
     
         14 . The medical device of  claim 10 , wherein said hydrophobic therapeutic agent is a restenosis-inhibiting agent.  
     
     
         15 . The medical device of  claim 14 , wherein said restenosis-inhibiting agent is C6-ceramide.  
     
     
         16 . A method for producing a drug-coated intravascular device, comprising: 
 producing a coating composition by mixing a drug composition comprising a drug and an oil-based non-volatile solvent in a volatile solvent,    coating said intravascular device with said coating composition; and    causing said volatile solvent to evaporate.    
     
     
         17 . The method of  claim 16 , wherein said oil-based non-volatile solvent comprises Vitamin E  
     
     
         18 . The method of  claim 16 , wherein said volatile solvent comprises an alcohol.  
     
     
         19 . The method of  claim 18 , wherein said alcohol is ethanol or isopropanol.  
     
     
         20 . The method of  claim 16 , wherein said drug is hydrophobic.  
     
     
         21 . The method of  claim 20 , wherein said hydrophobic drug is a restenosis-inhibiting agent.  
     
     
         22 . The drug-coated intravascular device produced by the method of  claim 16.