Formulations for drug-coated medical devices

摘要

The invention relates to an angioplasty catheter having a balloon and a constraining element carrying at least on a portion of its surface a taxane or taxane preparation and at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one antioxidant in relation to 100% by weight of the taxane, wherein a preferred lipophilic antioxidant is propyl gallate. Scoring or cutting balloons as medical devices are excluded.

主权项

1. An angioplasty balloon catheter characterized by a catheter shaft having an inflatable balloon at its distal end and a constraining structure constraining the expansion of the inflatable balloon, said constraining structure having a non-expanded configuration prior to inflation and an expanded configuration which is smaller than an unconstrained size of the balloon so that the structure restrains the balloon inflation along a plurality of crossing channel lines, carrying at least on a portion of said balloon's surface: a) paclitaxel or a polymer-free paclitaxel preparation; and b) at least one lipophilic antioxidant at a ratio of 3-100% by weight of the at least one antioxidant in relation to 100% by weight of the paclitaxel, wherein the at least one lipophilic antioxidant is selected of propyl gallate, nordihydroguaiarectic acid, or resveratrol, wherein scoring or cutting balloons as medical devices are excluded.