Evonik announced the launch of the RESOMER® Precise platform of custom functional polymeric excipients to allow pharmaceutical companies to control the release profile of their parenteral drug products to a previously impossible level of accuracy and precision. The new RESOMER® platform, which is enabled by a unique and highly sophisticated process technology developed by Evonik, will also help to optimize drug product stability and thereby further reduce regulatory risk for a range of complex parenteral drug products.
Custom excipients with product specifications as narrow as ± 0.02 dL/g for Inherent Viscosity (IV) can be attained with RESOMER® Precise, which is between four and 10 times more precise than standard industry polymers used with parenteral drug products. The platform can also deliver unprecedented levels of accuracy and precision for other key polymer quality attributes including molecular weight and glycolate block length.
RESOMER® Precise is suitable for use with more than 20 high and low molecular weight polymers for controlled release formulations from Evonik’s market-leading RESOMER® portfolio including PLA (Poly (D,L-lactide) and PLGA (Poly (D,L-lactide-co-glycolide). Like with other RESOMER® and RESOMER® Select polymers, Evonik can supply RESOMER® Precise grades at lab, clinical or commercial volumes from either of its cGMP facilities in the U.S. and Germany.
“Evonik has leveraged decades of leadership in polymerization technology to create RESOMER® Precise as a platform of customized excipients for which manufacturing processes can be validated to even the most extreme product specifications,” said Dr. Andreas Karau, Global Head of Biomaterials for Evonik Health Care. “RESOMER® Precise will deliver significant value to pharmaceutical companies who must satisfy regulatory authorities with respect to permanently increasing quality and safety standards for their parenteral drug products.”
Evonik Health Care is part of the Nutrition & Care segment of Evonik, and serves over a 1,000 pharmaceutical, nutraceutical and medical device customers worldwide. Its portfolio of products, technologies and services are a core element of the Health & Care growth engine, which helps drive Evonik’s profitable and balanced growth.
RESOMER® is the world’s leading portfolio of standard, custom and specialized bioresorbable functional polymers for use with pharmaceutical drug products and implantable medical devices. Pharmaceutical customers of Evonik Health Care also have access to a range of pharmaceutical ingredients, functional excipients and drug delivery technologies, as well as CMO and CDMO services for APIs, excipients and complex oral and parenteral drug products. Medical device customers can also benefit from the Endexo™ surface modification platform, and a range of application technology and scale-up services including 3D printing.
