Over the past few decades, drug coated balloons (DCBs) have emerged as an effective treatment method for the inhibition of restenosis, or artery re-blockage. There are several types of coating matrices used to produce DCBs. The active drug of choice is paclitaxel, in the presence of an excipient to facilitate drug transfer, because it has rapid uptake by the intima, a high retention rate and lipophilic characteristics. In the DCB industry there is a need for data that represents the relationship between variations in the coating procedure parameters and the impact it makes on the balloon’s coating integrity.   In our study, we have adapted an in-house micro-pipetting coating method to dispense a precise volume of coating solution onto the balloon surface as it is being translated and rotated at a specified rate. Our aim is to analyze the changes in the drug coating morphology along balloon surface as we alter coating parameters (e.g.,  revolution rate of the balloon, translational speed or flow rate) to determine the most optimal parameters to produce a uniformly coated DCB containing a drug dose of 3 µg/mm<sup>2</sup>. We have incorporated the use of scanning electron microscopy (SEM) for the analysis of the surface morphology, as well as, coating thickness throughout the effective balloon length. Additionally, we applied the use of high performance liquid chromatography (HPLC-UV) to confirm the drug content uniformity along the effective length of the balloon. Our data will be used to provide guidance to the DCB industry by giving an overview of the coating process and explaining why changing specific parameters will impact the integrity of the balloon coating. This information will also be useful for understanding how coating manufacturing variables influence the drug release profile in biological conditions. <br/>

Evaluation of coating integrity of drug coated balloons

254th National Meeting (2017)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.