Drug Composition and Coating

摘要

According to the invention there is provided inter alia 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; 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 lower temperature than the melting point of the therapeutic agent and the at least one 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 sterilization.

主权项

1. 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; 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 lower temperature than the melting point of the therapeutic agent and the at least one 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 sterilization.