Patent ID: 8404300

Claim:
A method for preparing a drug coated balloon catheter, the method comprising: (a) preparing a solution comprising: an organic solvent selected from the group consisting of hexane, octane, cyclohexane, heptane, benzene, toluene, xylene, methanol, ethanol, propanol, isopropanol, diethylamide, ethylene glycol monoethyl ether, Trascutol, benzyl alcohol, dioxane, dimethyl ether, tetrahydrofuran, ethyl acetate, isobutyl acetate, acetone, acetonitrile, diethyl ketone, methyl ethyl ketone, dimethylformamide, dimethylsulfoxide, mixtures of water and ethanol, mixtures of water and acetone, mixtures of water and methanol, mixtures of water and tetrahydrofuran, and combinations thereof; a therapeutic agent selected from the group consisting of paclitaxel, rapamycin, and mixtures thereof; at least one first additive selected from the group consisting of PEG sorbitan monolaurates, PEG sorbitan monooleates, and mixtures thereof; and at least one additional additive selected from the group consisting of sorbitol, sorbitan, gluconolactone, and mixtures thereof; (b) forming a coating layer containing the therapeutic agent and the at least one additive on an exterior surface of a balloon of a balloon catheter to form the drug coated balloon catheter by: (i) applying the solution to the balloon in an inflated or partially inflated state; and (ii) drying the balloon to evaporate the organic solvent from the coating solution after the solution is applied; and (c) deflating and folding the balloon, wherein the ratio by weight of the additives to the therapeutic agent in the coating layer is from 0.05 to 100.