Elutia (ELUT) announced the publication of a peer-reviewed article describing the first validated method for measuring antibiotic release from a biologic envelope. The novel method demonstrates in vitro elution that closely replicates preclinical studies, offering an approach to characterize drug release while enabling faster, lower cost development and testing of the EluPro portfolio. The article appears in the current issue of Dissolution Technologies. Drug release testing is a critical element of product development and regulatory evaluation for combination products, which integrate drugs and devices. The U.S. Food and Drug Administration considers drug elution performance essential for establishing manufacturing consistency and control. Elutia’s new method delivers reliable data in 30 hours-for results comparable to 14-day in vivo protocols-allowing for faster iteration and lower resource usage. It captures the biphasic release profile of minocycline and rifampin, including both the immediate and sustained release phases.
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