| abstract |
A medical device for delivering a therapeutic agent to tissue, the device having a solid particulate coating layer free of surfactants applied to a surface of the device, the coating layer comprising a therapeutic agent and at least one non-polymeric organic additive that is hydrolytically stable; wherein at least a proportion of the particulate coating layer comprising the therapeutic agent and the at least one organic additive melts as a single phase at a temperature lower than the melting point of the therapeutic agent and the at least one organic additive when they are in pure form; wherein the therapeutic agent is paclitaxel; wherein the therapeutic agent, when formulated in the coating layer, is stable against sterilization; and wherein each at least one organic additive is independently selected from the list consisting of p-aminobenzoic acid, saccharin, ascorbic acid, methyl paraben, caffeine, calcium salicylate, pentetic acid, creatinine, ethylurea, acetaminophen, aspirin, theobromine, tryptophan, succinic acid, adipic acid, glutaric acid, theophylline and sodium saccharin. |