Acute drug transfer and particle release of drug coated balloons within a porcine in-vitro model

Abstract

Drug coated balloons (DCB) are used in the therapy of coronary as well as peripheral artery disease. The success of drug transfer to the vessel wall depends on the excipient used in combination with paclitaxel as antiproliferative drug. Although in-vivo studies show very good results with this technology, there is a lack of in-vitro test methods for characterization of various DCB available on the market. This study describes a method to gain information about the drug transfer and the particle release of three different DCB based on cetylpyridinium salycate (Cetpyrsal), hyaluronic acid and iopromide within a porcine in-vitro model. The Cetpyrsal-based DCB showed promising results with the highest drug transfer while producing the lowest number of particles.

Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons

“…The recent literature [12][13][14][15][16] reports several methods for measuring the loss of paclitaxel. Kelsch et al 12 used a shake test to measure the adherence of the dry coating.…”

“…After the DCB was pushed through the model to the silicone test tube, the balloon was inflated with 7 bar for 30 s. For quantification, HPLC was used. Brandt-Wunderlich et al 16 inserted a DCB into a porcine carotid artery in a vial with saline solution. The balloon was inflated and the pressure was held for 30 s. Afterwards, the balloon was deflated and removed from the artery and the vial.…”

“…The recent literature 12 – 16 reports several methods for measuring the loss of paclitaxel. All methods proposed treat the particle loss by handling during angioplasty as a black box.…”