07-01-2016 дата публикации
Номер: US20160000977A1
Принадлежит:
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. 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.2. A method for preparing a medical device according to claim 1 , which comprises the steps of combining the therapeutic agent and the at least one organic additive in powder form claim 1 , and then applying the powder to the device to form a solid particulate composition and optionally applying a subsequent thermal treatment step. The present invention relates to solid paclitaxel compositions, medical devices with coatings comprising solid paclitaxel compositions and to ...
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