Drug-coated medical devices

A drug-coated medical device comprising:

• a balloon having an inner surface and an outer hydrophobic surface;
• an adhesion balance layer directly on the outer hydrophobic surface of the balloon, comprising a hydrophilic polymer and/or a hydrophilic compound, where the hydrophilic polymer has a number average molecular weight of from 10,000 to 10,000,000 Daltons and the hydrophilic compound is a sugar with a molecular weight of less than 1,000 Daltons;
• and
• a therapeutic layer directly on the adhesion balance layer comprising a therapeutic agent and a pharmaceutically acceptable carrier, wherein:
• the therapeutic agent is a hydrophobic therapeutic agent with one or more hydrogen-bonding groups and is provided as discrete drug particles in the therapeutic layer;
• the drug particles have at least one dimension that is less than 25 μm and are uniformly distributed on the surface of the balloon;
• and
• the pharmaceutically acceptable carrier is hydrophilic and has a molecular weight of less than 1,000 Daltons, and is selected from one or more of the group consisting of tartaric acid, a sugar, and a sugar alcohol;
• and
• the amount of the pharmaceutically acceptable carrier to therapeutic agent in the therapeutic layer is from 1:8 to 4:1 wt/wt.