1. Scope
1.1 This guide describes recommended acute in-vitro characterization methods for drug
coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness,
drug coating uniformity, and released particulates. Specifically, this guide details:
1.1.1 Characterization of integrity by inspection of the coated balloon surface.
1.1.2 Measurement of coating thickness.
1.1.3 Quantitation of drug coating uniformity (uniformity of drug distribution over the
balloon surface) longitudinally and circumferentially.
1.1.4 Quantitation of the number of particulates released, in various size ranges, during
simulated use testing (insertion, tracking, deployment, retraction, and withdrawal)
along with chemical and crystallinity characterization of particulates.