Drug coated balloons (DCBs) have proven to be a suitable alternative for the treatment of cardiovascular diseases. They allow for uniform delivery of an antiproliferative drug to the stenotic site without permanent implantation of the device in the patient's body. There are, however, regulatory concerns regarding the lack of data associated with variable drug delivery to the target site, which can be related to the coating process. This study describes the process for an in-house micro-pipetting coating method that incorporates a laboratory-developed coating equation for determining optimal coating parameters. The coating solutions included a common drug of choice, paclitaxel, along with a hydrophilic excipient, such as iopromide. It was found that using a revolution rate of 240 rev/min, a flow rate of 25 µL/min and a translational speed of 0.033 cm/s resulted in visually uniform coatings. High performance liquid chromatography (HPLC) allowed for the determination of paclitaxel content on the balloon surface. Scanning electron microscopy (SEM) enabled analysis of coating thickness and texture at distal, middle, and proximal positions on the balloon; average thicknesses were determined to be 16.4 ± 5.8, 14.8 ± 1.4, and 18.1 ± 3.9 µm, respectively. These optimized coating conditions have been confirmed by in vitro drug release kinetics studies. Overall this study generated a simple and reproducible micro-pipetting coating method for the sustained release of drugs from the drug coated balloons.
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Article Synopsis
- The study investigated how different treatments (balloon angioplasty vs. drug-coated balloons) affect the changes in blood vessel tissues following arteriovenous fistula stenosis in pigs with chronic kidney disease.
- Significant differences in tissue composition were observed, with drug-coated balloons leading to lower neointimal growth and higher endothelial cell counts compared to standard angioplasty.
- The findings suggest that using drug-coated balloons may improve vessel healing and reduce complications over time, as shown by varied immune cell responses and tissue growth patterns.
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