Industry Session
Mohammed Syed, n/a
Associate Director FAS, Graduate Researcher
Formulation Application Services
Evonik Corporation, St. Johns University
Hillsborough, New Jersey, United States
Recently, the number of new oral drug products launched has declined, even as R&D expenditures have risen. This trend is attributed to several challenges, including lengthy screening and discovery phases, distinct drug characteristics, the need for targeted drug delivery systems, and extended product development timelines. Addressing these obstacles and ensuring strong pharmacokinetic performance from the drug discovery phase to commercial production is particularly challenging. A cohesive solution that spans from pre-clinical to commercial stages could alleviate these difficulties. Specifically, a delivery system that minimizes drug sensitivity and stability issues, streamlines pharmaceutical manufacturing processes, and reliably targets active ingredients to specific areas of the gastrointestinal tract is essential. The technology introduced here is a ready-to-use, enteric-coated capsule platform designed for targeted drug delivery, simplifying manufacturing and accelerating the time to market. This innovative enteric- coated capsule concept is applicable throughout all phases of drug development, from pre-clinical assessments to commercial-scale production, without necessitating formulation alterations. This presentation will focus on the details of the enteric capsule products (EUDRACAP® Enteric and EUDRACAP® Colon) and will provide performance data supported by case studies that feature model drugs suitable for both pre-clinical and clinical applications.