Evonik Health ’s new Resomer Precise platform of custom functional polymeric excipients reportedly allow pharmaceutical corporations to manage the discharge profile of parenteral drug merchandise with a excessive stage of accuracy and precision. According to the corporate, the road of excipients additionally will allow customers to achieve a excessive diploma of product stability, serving to cut back regulatory dangers.
Andreas Karau, world head of biomaterials for Evonik Health Care, stated the corporate provides an a variety of benefits to pharmaceutical corporations and improvement companions involved about product high quality and security.
“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,” stated Karau. “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.”
The firm stories the custom excipients supply product specs as slim as ± 0.02 dL/g for inherent viscosity (IV), as much as 10 occasions extra exact than commonplace trade polymers used with parenteral drug merchandise. The platform reportedly additionally delivers favorable ranges of accuracy and precision for different key polymer high quality attributes together with molecular weight and glycolate block size.
The Resomer Precise line is designed to be used with greater than 20 excessive and low molecular weight polymers for managed launch formulations from Evonik’s Resomer portfolio; these embody PLA (Poly (D,L-lactide) and PLGA (Poly (D,L-lactide-co-glycolide). The producer can provide Resomer Precise grades at lab, scientific or business volumes from both of its cGMP amenities within the US and Germany.