In Vitro Evaluation Method for Drug Release and Particle Release from Drug Coated Balloon

Objective Development in vitro test methods for drug release and particle release from drug coated balloon to address the disadvantages and inadequacy of existing assessment methods.Methods In vitro drug transfer test were carried out using the isolated porcine vessel as target site in the self-designed iliofemoral artery model, drug loss experiment during dilatation and retraction were added in drug release test, the particle test channel was subdivided and the size and number of the large particles were measured by microscopy combined with Image-Pro Plus software.Results The result shows that the method is feasible and the discrimination is good. The material balance can be achieved. More detailed data can be obtained.Conclusion The developed in vitro evaluation method provides a reference for formulation screening, in vitro bench testing and in vivo pre-clinical animal testing.