Coatings with tunable solubility profile for drug-coated balloon

Abstract

A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and 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.

What is claimed is: 
     
         1 . A balloon for delivery of a drug, the balloon comprising:
 a body having an outer surface; and   a coating disposed on at least a length of the outer surface, the tunable coating including zotarolimus and at least one excipient including polyvinylpyrrolidone or polyethylene glycol, the coating having a dissolution time of about 10 seconds to about 1 hour, wherein the at least one excipient increases the solubility of the zotarolimus to between about 4 ug/ml to about 1437 ug/ml.   
     
     
         2 . The balloon of  claim 1 , wherein the at least one excipient is blended with a contrast agent. 
     
     
         3 . The balloon of  claim 1 , wherein the at least one excipient includes a polymer having a molecular weight of less than about 35 kDalton. 
     
     
         4 . The balloon of  claim 1 , wherein the at least one excipient includes a polymer having a molecular weight greater than about 100 kDalton. 
     
     
         5 . The balloon of  claim 1 , wherein the coating further includes a plasticizer. 
     
     
         6 . The balloon of  claim 5 , wherein the plasticizer is glycerol. 
     
     
         7 . The balloon of  claim 1 , wherein the dissolution rate is about 10 seconds to 10 minutes. 
     
     
         8 . A balloon for delivery of a therapeutic agent, the balloon comprising:
 a body having an outer surface; and   a coating disposed on at least a length of the outer surface, the coating including a first therapeutic agent and a first excipient having a first dissolution rate, and a second therapeutic agent and a second excipient having a second dissolution rate, wherein the first therapeutic agent is zotarolimus, the first excipient is polyvinylpyrrolidone or polyethylene glycol, and the weight ratio of zotarolimus to the first excipient is from about 20:1, to about 1:20, and wherein the first excipient increases the solubility of the zotarolimus to between 4 μg/ml to 1437 μg/ml.   
     
     
         9 . The balloon of  claim 8 , wherein the first therapeutic agent is different than the second therapeutic agent. 
     
     
         10 . The balloon of  claim 8 , wherein the first excipient has a molecular weight of less than about 35 kDalton. 
     
     
         11 . The balloon of  claim 8 , wherein the second excipient is a polymer having a molecular weight greater than about 100 kDalton. 
     
     
         12 . The balloon of  claim 8 , wherein the second excipient is polyvinylpyrrolidone or polyethylene glycol. 
     
     
         13 . The balloon of  claim 8 , wherein the second excipient is a biodegradable polymer. 
     
     
         14 . The balloon of  claim 13 , wherein the biodegradable polymer is Poly(D, L-lactide-co-glycolide) or Poly(L-lactide-co-ε-caprolactone). 
     
     
         15 . The balloon of  claim 8 , wherein the second excipient is a protein polymer. 
     
     
         16 . The balloon of  claim 8 , wherein the second therapeutic agent is paclitaxel. 
     
     
         17 . The balloon of  claim 8 , wherein both the first and second therapeutic agents are zotarolimus. 
     
     
         18 . The balloon of  claim 8 , wherein the second therapeutic agent is sirolimus. 
     
     
         19 . The balloon of  claim 8 , wherein the coating includes a third therapeutic agent and a third excipient. 
     
     
         20 . The balloon of  claim 8 , wherein the coating includes first and second layers adsorbed to the surface of the balloon. 
     
     
         21 . The balloon of  claim 20 , wherein the first layer consists of the first therapeutic agent and first excipient and the second layer consists of the second therapeutic agent and the second excipient. 
     
     
         22 . The balloon of  claim 20 , wherein the first and second layers each has a dissolution time, the dissolution time of the first layer being different than the dissolution time of the second layer. 
     
     
         23 . The balloon of  claim 8 , wherein at least one of the first or second excipients is a carboxylated aromatic compound. 
     
     
         24 . The balloon of  claim 8 , wherein at least one of the first or second excipients is halogenated. 
     
     
         25 . The balloon of  claim 8 , wherein at least one of the first or second excipients is alkylated. 
     
     
         26 . The balloon of  claim 8 , wherein the first therapeutic agent is released from the coating, and the second therapeutic agent is released with the coating. 
     
     
         27 . The balloon of  claim 8 , wherein at least one excipient is blended with a contrast agent. 
     
     
         28 . The balloon of  claim 27 , wherein the contrast agent is Ultravist 
     
     
         29 . The balloon of  claim 8 , wherein the balloon is free of a stent.