Application of Quality by Design (QbD) Approach to Ultrasonic Atomization Spray Coating of Drug-Eluting Stents

Abstract

Abstract. The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter-and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) 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. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.

Quality-by-Design approach to the fluid-bed coating of ginkgo lactone nanosuspensions

“…Moreover, this technique can be used to evaluate the relationships between those factors and dene a product quality design space. 17 Ginkgo lactones (GLs) have recently attracted considerable attention. 18 These natural lactones could bind to the membrane receptors, inhibit the platelet-activating factor, and produce anticoagulant effect.…”

Development and Biological Evaluation of Inkjet Printed Drug Coatings on Intravascular Stent

“…To date, spray coating and dip coating have been reported as the main technologies to apply drug/polymer layers on the stent strut. In spray coating, a nozzle sprays a drug–polymer solution generating droplets with diameter of 10–15 μm on a stent . In the case of dip coating, the stent is deposited in the coating solution and subsequently spun to remove the excess material.…”

“…In spray coating, a nozzle sprays a drug−polymer solution generating droplets with diameter of 10−15 μm on a stent. 11 In the case of dip coating, the stent is deposited in the coating solution and subsequently spun to remove the excess material. This process is repeated until the appropriate amount of drug is deposited.…”