Loading and release of water-insoluble drugs

Abstract

A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

1 - 67 . (canceled)  
     
     
         68 . A patterned stent for delivering a substantially water-insoluble drug at a desired location within a body, comprising 
 a polyvinyl aromatic polymer coating containing the substantially water-insoluble drug provided on at least a portion of said patterned stent, wherein the substantially water insoluble drug is released from said stent over a time frame sufficient to thereby prevent or inhibit undesired cellular proliferation, wherein the time frame is at least about seven days.    
     
     
         69 . The patterned stent of  claim 68 , wherein said polymer coating is layered.  
     
     
         70 . The patterned stent of  claim 68 , wherein the at least one water-insoluble drug comprises a combination of paclitaxel and an agent selected from the group consisting of anticoagulants, antimitotics, antithrombogenics, thrombolytics, anti-inflammatory agents, antioxidants, growth factors, modulators of vascular homeostasis, cytocidal agents, and cytostatic agents.  
     
     
         71 . The patterned stent of  claim 68 , wherein the at least one water-insoluble drug is released from said stent over a time frame effective to inhibit proliferative disease when said stent is positioned at a site of injury to thereby prevent or inhibit undesired cellular proliferation.  
     
     
         72 . The patterned stent of  claim 71 , wherein the time frame is at least about 28 days.  
     
     
         73 . The patterned stent of  claim 71 , wherein the at least one water-insoluble drug is released at a rate in the range of from about 0.2 to about 7 mg per day.  
     
     
         74 . The patterned stent of  claim 71 , wherein the at least one water-insoluble drug is released at a rate in the range of from about 0.5 to about 5 mg per day.  
     
     
         75 . The patterned stent of  claim 68 , wherein said polyvinyl aromatic polymer is a copolymer.  
     
     
         76 . A method of preventing or inhibiting proliferative disease at a site of blood vessel injury in a patient comprising implanting a patterned stent comprising an outer coating of polyvinyl aromatic polymer and at least one water-insoluble drug at the site of injury, wherein the at least one water-insoluble drug is released from the outer coating over a time frame sufficient to inhibit or prevent undesired cellular proliferation at the site of injury, wherein the time frame is at least about seven days.  
     
     
         77 . The method of  claim 76 , wherein the at least one water-insoluble drug is released from the outer coating at a release rate of from about 0.2 to about 7 mg/day.  
     
     
         78 . The method of  claim 76 , wherein the at least one water-insoluble drug is released from the outer coating at a release rate and for a period of time sufficient to inhibit or prevent neointima formation at the site of injury.  
     
     
         79 . The method of  claim 76 , wherein the proliferative disease is restenosis.  
     
     
         80 . The method of  claim 76 , wherein the at least one water-insoluble drug comprises paclitaxel.  
     
     
         81 . The method of  claim 76 , wherein said polyvinyl aromatic polymer is a copolymer.  
     
     
         82 . A method of preventing or inhibiting proliferative disease in a patient comprising implanting a patterned stent comprising an outer coating of polyvinyl aromatic polymer and at least one water-insoluble drug at a site of cellular proliferation, wherein the at least one water-insoluble drug is released from the outer coating at a relese rate and for a period of time sufficient to inhibit or prevent undesired cellular proliferation at the site, wherein the period of time is at least about seven days.  
     
     
         83 . The method of  claim 82 , wherein the at least one water-insoluble drug is released from the outer coating for a period of time from about 7 to about 28 days.  
     
     
         84 . The method of  claim 82 , wherein the at least one water-insoluble drug is released from the outer coating at a release rate of from about 0.2 to about 7 mg/day.  
     
     
         85 . The method of  claim 82 , wherein the at least one water-insoluble drug is released from the outer coating at a release rate and for a period of time sufficient to inhibit or prevent neointima formation at the site.  
     
     
         86 . The method of  claim 82 , wherein the proliferative disease is restenosis.  
     
     
         87 . The method of  claim 82 , wherein said polyvinyl aromatic polymer is a copolymer.