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Nov, 03, 2014
Expands lead-user program for breakthrough technology, providing customers with a new approach for enteric drug delivery
Morristown, N.J., November 3, 2014 – Capsugel announced today the expansion of its lead-user customer-collaboration program for its intrinsically enteric capsule technology. This breakthrough drug-delivery technology integrates industry-approved enteric polymers in the capsule design, enabling Capsugel to offer the first fully enteric dosage form without the need to apply functional coatings.
“Finding better ways to protect gastric-sensitive active ingredients is one of the pharmaceutical industry’s biggest challenges. Capsugel’s intrinsically enteric capsule technology provides a novel solution,” said Amit Patel, President, Dosage Form Solutions, Capsugel. “The advantages of this innovative technology include minimal excipients needed for formulation, improvement of upper gastrointestinal safety, and differentiated pharmacokinetic performance. It can also accelerate product development while supporting Quality by Design through scale-up and commercial manufacturing.”
Capsugel’s enteric capsule technology lead-user programs include feasibility studies with selected customers that target oral vaccine and peptide delivery, as well as early-stage development programs for small chemical entities that could benefit from an intrinsically enteric dosage form. Under the feasibility program, lead users are granted access to the technology and associated intellectual property, as well as dedicated scientific, product development and regulatory support services.
“Our intrinsically enteric capsule technology significantly enhances Capsugel’s technology selection toolkit for our customers. It combines our drug formulation, polymer chemistry and capsule-design expertise to achieve this targeted drug-delivery characteristic,” said Keith Hutchison, PhD, Senior Vice President, Research & Development, Capsugel. “Our initial lead-user programs have confirmed performance, and we expect a range of applications for both large and small molecules as we continue to apply and advance the technology with additional customers to new and existing pharmaceutical compounds.”
This new technology complements Capsugel Dosage Form Solutions’ array of modified and targeted release technologies utilized to optimize drug delivery, including a range of multiparticulate formulation options, osmotic tablets, bi- and tri-layered matrices, dual capsule technology and colonic delivery approaches.
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care industry. The company’s Hard Capsule business unit offers customers the broadest portfolio of gelatin, vegetarian and other specialized capsule technologies. Capsugel’s Dosage Form Solutions business unit solves customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. Capsugel Dosage Form Solutions accelerates and improves product development through an array of proprietary technologies including lipids and liquids, spray-dried dispersions, hot-melt extrusions, and through specialized manufacturing including FDA/MHRA-accredited finished dosage sites that can handle highly potent, controlled substance, hormonal and oncology compounds. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.