Ultrasonic Coating of Drug-Eluting Stents
Ultrasonic Coating of Drug-Eluting Stents. Ultrasonic Atomization Spray Coating of Drug-Eluting Stents
The drug coating process for coated drug-eluting stents has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design principles were applied to gain an understanding of the ultrasonic spray coating process of coated drug-eluting stents.
Statistically based design of experiments were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics.
Our ultrasonic coating systems have been used to spray anti-restenosis drug eluting polymer solutions onto implantable stents for decades.
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