Approximately 8.5 million people in the United States have peripheral arterial disease (PAD), which is the narrowing of vessels that carry blood from the heart to the body’s extremities and is primarily caused by the build-up of fatty plaque in the arteries (stenosis).   Balloon angioplasty and bare metal stents were initially used for the treatment of stenosis, but re-stenosis (re-blockage) became the rate limiting factor for these procedures. Drug coated balloons (DCB) have emerged as the alternative procedure for re-stenosis because of their ability to treat a variety of occlusion types with a uniform dose of anti-proliferative drugs. There are several types of coating matrices used to produce DCBs. In this study, the relationship between coating composition and drug release under physiologically relevant conditions was examined to understand how differences in coating composition impact the drug transfer from the balloon surface to the simulated body fluids. To conduct the experiments, the balloons were coated using an in-house developed micro-pipetting method. Paclitaxel (PTX) was used as the anti-tumor drug because it reduces cell proliferation and Iopromide (IOP) was used as the excipient because it allows for the drug to adhere to the target site longer. Balloons were coated with different drug-to-excipient ratios (3:1, 3:2 and 1:2 drug-to-excipient ratio respectively). In vitro drug release kinetics were studied with Vention balloons. A track and deploy method was performed utilizing a “mock” artery using coated POWERFLEX Extreme balloon catheters to simulate an in-vitro environment. The amount of drug released to the medium, at each time point, was quantified by high performance liquid chromatography (HPLC). In vitro drug release kinetics studies showed that the coating conditions used for micro-pipetting method affects the drug release rate into the simulated fluid. Scanning electron microcopy (SEM) images showed that 3:1 ratio produced more uniform and thin coating throughout the balloon surface compared to the other drug-to- excipient ratios. Track and deploy studies showed that 3:1 drug-to-excipient ratio is the most effective coating ratio for this procedure, since it produces the highest drug recovery. This data provides useful information for understanding how coating composition influences the drug release profile under simulated conditions. <br/>

Evaluation of drug-to-excipient ratio effects on the drug release profile in drug coated balloons

2019 Spring National Meeting

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