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; and 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. 1.2 This guide does not address: 1.2.1 Mechanical testing of DCBs; 1.2.2 Drug substance evaluation of DCBs (for example, assay, related substances, and uniformity of dosage units); 1.2.3 Production release and stability testing, although some sections may be applicable in whole or in part; and 1.2.4 Standard analytical testing (for example, drug content, drug-related substances, and drug uniformity of dosage). 1.3 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordscoating inspection; drug-coating uniformity; drug-coated balloon; DCB; particulate; particulate characterization; simulated use
Provide consensus for the acute evaluation of durability for drug-coated balloons.Back to Top