Drug composition and coating

A medical device for delivering a therapeutic agent to a tissue, the device having a solid surfactant-free particulate coating layer applied to a surface of the device, the coating layer comprising a therapeutic agent and at least one non-polymeric organic additive which is hydrolytically stable, independently selected from the group consisting of p-aminobenzoic acid, methyl paraben, caffeine, and calcium salicylate;

• wherein:
• when the least one non-polymeric organic additive is p-aminobenzoic acid, the weight ratio of paclitaxel to p-aminobenzoic acid is from 3:7 to 9:1,
• when the least one non-polymeric organic additive is methyl paraben, the weight ratio of paclitaxel to methyl paraben is from 4:5 to 9:1,
• when the least one non-polymeric organic additive is caffeine, the weight ratio of paclitaxel to caffeine is from 7:3 to 95:5,
• when the least one non-polymeric organic additive is calcium salicylate, the weight ratio of paclitaxel to calcium salicylate is from 7:3 to 9:1,
• wherein at least a proportion of the particulate coating layer comprising the therapeutic agent and the at least one non-polymeric organic additive melts as a single phase at a lower temperature than the melting point of the therapeutic agent and the at least one non-polymeric organic additive when in pure form;
• wherein the therapeutic agent is paclitaxel;
• and wherein the therapeutic agent, when formulated in the coating layer, is stable to ethylene oxide sterilization;
• wherein the coating layer comprises crystalline particles of the therapeutic agent and the at least one non-polymeric organic additive in co-crystalline form.