Compositions and methods for coating medical devices

Abstract

The present invention provides compositions and methods for coating medical devices with pharmaceutical agents and devices coated with the compositions. The coated devices provide controlled or sustained release of pharmaceutical agents for the treatment of wounds or disease.

1 . A composition for coating medical devices comprising at least one biocompatible biodegradable polymer in an amount of about 0.01% to 15% (w/v) and at least one pharmaceutical agent in an amount of about 0.01% to 10% (w/v) and having a viscosity of about 30 to 50 centipoise.  
     
     
         2 . The composition according to  claim 1 , wherein the pharmaceutical agent is a nucleic acid that stimulates or promotes wound healing.  
     
     
         3 . The composition according to  claim 2 , wherein the nucleic acid is a DNA molecule operably linked to a DNA sequence encoding a therapeutic protein selected from the group consisting of: transforming growth factor-β (TGF-β); fibroblast growth factor (FGF); platelet derived growth factor (PDGF); insulin-like growth factor (IGF); bone morphogenic growth factor (BMP); growth hormone (GH) and human parathyroid hormone (PTH).  
     
     
         4 . The composition according to  claim 1 , further including a liquified propellant.  
     
     
         5 . A composition for coating medical devices comprising a suspension of about 0.01% (w/v) to 80% (w/v) microspheres and/or nanospheres and having a viscosity of about 30 to 50 centipoise, wherein the microspheres and/or nanospheres are comprised of a biocompatible biodegradable polymeric core and at least one pharmaceutical agent in an amount of about 0.01% to 20% (w/w).  
     
     
         6 . The composition according to  claim 5 , wherein the pharmaceutical agent is a nucleic acid that stimulates or promotes wound healing.  
     
     
         7 . The composition according to  claim 5 , further including a bioadhesive.  
     
     
         8 . The composition according to  claim 5 , further including a liquefied propellant.  
     
     
         9 . A method for coating a medical device with a polymeric matrix containing at least one pharmaceutical agent, the method comprising the steps of: 
 (a) preparing an emulsion comprising at least one biocompatible biodegradable polymer in an amount of about 0.01% to 15% (w/v) and at least one pharmaceutical agent in an amount of about 0.01% to 10% (w/v) and having a viscosity of about 30 to 50 centipoise; and    (b) coating a medical device with a pharmaceutically effective amount of the emulsion.    
     
     
         10 . The method according to  claim 9 , wherein the emulsion is a water-in-oil emulsion.  
     
     
         11 . The method according to  claim 9 , wherein the pharmaceutical agent is a hydrophobic pharmaceutical agent and preparing the emulsion comprises the steps of: 
 (a) dissolving the hydrophobic pharmaceutical agent in a water-immiscible organic solvent to yield an organic phase; and    (b) emulsifying the organic phase with an aqueous phase to yield a milky emulsion.    
     
     
         12 . The method according to  claim 9 , wherein the pharmaceutical agent is a hydrophilic pharmaceutical agent and preparing the emulsion comprises the steps of: 
 (a) dissolving at least one biocompatible biodegradable polymer in a water-immiscible organic solvent to yield an organic phase;    (b) dissolving the hydrophilic pharmaceutical agent in water to yield an aqueous phase; and    (c) emulsifying the organic and aqueous phases to yield a milky emulsion.    
     
     
         13 . The method according to  claim 9 , wherein the pharmaceutical agent is a semi-polar and/or hydrophilic pharmaceutical agent and preparing the emulsion comprises the steps of: 
 (a) dissolving at least one biodegradable biocompatible polymer in a water-immiscible organic solvent;    (b) dissolving at least one semi-polar and/or hydrophilic pharmaceutical agent in a water-miscible organic solvent;    (c) admixing the solutions from steps (a) and (b) to yield an organic phase; and    (d) emulsifying the organic phase with an aqueous phase to yield a milky emulsion.    
     
     
         14 . The method according to  claim 9 , wherein the pharmaceutical agent is a nucleic acid that stimulates or promotes wound healing.  
     
     
         15 . The coated medical device produced by the method of  claim 9 .  
     
     
         16 . A method for coating a medical device with microspheres and/or nanospheres containing pharmaceutical agents, the method comprising the steps of: 
 (a) preparing a suspension comprising about 0.01% to 80% (w/v) microspheres and/or nanospheres and having a viscosity of about 30 to 50 centipoise, wherein the microspheres and/or nanospheres are comprised of a biocompatible biodegradable polymeric core and at least one pharmaceutical agent in an amount of about 0.01% to 10% (w/w); and    (b) coating a medical device with a pharmaceutically effective amount of the suspension.    
     
     
         17 . The method according to  claim 16 , wherein the pharmaceutical agent is a nucleic acid that stimulates or promotes wound healing.  
     
     
         18 . The coated medical device produced by the method of  claim 16 .  
     
     
         19 . A medical device coated with a polymeric matrix containing pharmaceutical agents, wherein the polymeric matrix comprises at least one biocompatible biodegradable polymer and a pharmaceutically effective amount of at least one pharmaceutical agent.  
     
     
         20 . The device according to  claim 19 , wherein the pharmaceutical agent is hydrophilic.  
     
     
         21 . The device according to  claim 19 , wherein the pharmaceutical agent is a nucleic acid.  
     
     
         22 . The device according to  claim 19 , wherein the polymeric matrix is in the form of microspheres and/or nanospheres.  
     
     
         23 . A medical device having improved wound healing characteristics, comprising a medical device coated with a biocompatible biodegradable polymeric matrix containing a therapeutically effective amount of a nucleic acid that stimulates wound healing.  
     
     
         24 . The device according to  claim 19  or  23 , wherein the device is selected from the group consisting of surgical implants, surgical sutures and wound dressings.  
     
     
         25 . A method for delivering pharmaceutical agents to a region of a body having wounded or diseases tissue, the method comprising the steps of: 
 (a) providing a medical device coated with a polymeric matrix containing pharmaceutical agents, wherein the polymeric matrix comprises at least one biocompatible biodegradable polymer and a pharmaceutically effective amount of at least one pharmaceutical agent; and    (b) placing the coated device proximal to a wound or diseased tissue.    
     
     
         26 . The method according to  claim 25 , wherein the nucleic acid is a nucleic acid that stimulates or promotes wound healing when taken up by cells.  
     
     
         27 . The method according to  claim 25 , wherein the medical device is selected from the group consisting of surgical implants, surgical sutures and wound dressings.