公开(公告)号：WO2015136106A1

公开(公告)日：2015-09-17

申请号：PCT/EP2015/055366

申请日：2015-03-13

申请人： W. L. GORE & ASSOCIATES, INC. ,  CARMEDA AB

发明人： DRUMHELLER, Paul, D. ,  CLEEK, Robert, L. ,  JOHNSON, Todd, J. ,  HOLLAND, Theresa, A.

IPC分类号： A61M25/00 ,  A61M31/00 ,  A61K31/337 ,  A61K31/436

CPC分类号： A61L27/54 ,  A61F2/07 ,  A61F2/915 ,  A61F2002/91575 ,  A61K31/337 ,  A61K31/436 ,  A61K31/727 ,  A61K45/06 ,  A61L27/28 ,  A61L29/08 ,  A61L29/085 ,  A61L29/16 ,  A61L31/048 ,  A61L31/08 ,  A61L31/10 ,  A61L31/16 ,  A61L33/0035 ,  A61L33/0076 ,  A61L33/04 ,  A61L33/064 ,  A61L2300/216 ,  A61L2300/416 ,  A61L2300/42 ,  A61L2300/602 ,  A61L2300/606 ,  A61L2300/61 ,  A61L2420/02 ,  A61L2420/06 ,  A61K2300/00

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.

摘要翻译： 根据本发明，提供了一种用于将治疗剂递送到组织的医疗装置，该装置具有施加到装置的表面上的固体无表面活性剂的颗粒涂层，该涂层包含治疗剂并且至少 一种水解稳定的非聚合有机添加剂; 其中包含所述治疗剂和所述至少一种有机添加剂的所述颗粒包衣层的至少一部分在纯度下在比所述治疗剂和所述至少一种有机添加剂的熔点低的温度下熔融为单相; 其中所述治疗剂是紫杉醇; 并且其中所述治疗剂在配制在所述涂层中时对于灭菌是稳定的。