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, according to the company. The platform can also deliver high 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 Andreas Karau, global head of biomaterials, 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.”