Drug releasing coatings for medical devices

A balloon catheter for delivering a therapeutic agent to a target site of a body lumen chosen from an esophagus, an airway, a sinus, a trachea, a colon, a biliary tract, a urinary tract, or a prostate, the balloon catheter comprising a balloon and a coating layer overlying external surfaces of the balloon, wherein:

• the coating layer comprises a water-soluble first additive and a hydrophobic therapeutic agent;
• the hydrophobic therapeutic agent is chosen from paclitaxel, rapamycin, everolimus, docetaxel, daunorubicin, doxorubicin, beta-lapachone, biologically active vitamin D, or combinations thereof;
• and
• the water-soluble first additive comprises gluconolactone or a PEG fatty ester chosen from PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates.

A method for treating a diseased body lumen, the method comprising:

• inserting a balloon catheter into a diseased body lumen to a target site in the diseased body lumen, the diseased body lumen chosen from an esophagus, an airway, a sinus, a trachea, a colon, a biliary tract, a urinary tract, or a prostate, the balloon catheter comprising a balloon and a coating layer overlying external surfaces of the balloon, wherein:
• the coating layer comprises a water-soluble first additive, a water soluble second additive, and a hydrophobic therapeutic agent;
• the hydrophobic therapeutic agent is chosen from paclitaxel, rapamycin, everolimus, docetaxel, daunorubicin, doxorubicin, beta-lapachone, biologically active vitamin D, or combinations thereof;
• and
• the water-soluble first additive comprises gluconolactone or a PEG fatty ester chosen from PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan monolaurates, PEG sorbitan monooleates, PEG sorbitan stearates, PEG sorbitan laurates, PEG sorbitan oleates, and PEG sorbitan palmitates;
• inflating the balloon catheter until the coating layer contacts walls of the diseased body lumen at the target site and releases therapeutic agent to the walls of the diseased body lumen;
• deflating the balloon catheter;
• and
• withdrawing the balloon catheter from the diseased body lumen.