Evonik launches Resomer Precise custom functional excipients

By Jenni Spinner

- Last updated on GMT

(MJ_Prototype/iStock via Getty Images Plus)
(MJ_Prototype/iStock via Getty Images Plus)

Related tags Excipients Manufacturing Pharmaceutical drug Evonik

The company reportedly is harnessing sophisticated technology to enable process validation of polymers to tight specifications in parenteral drugs.

Evonik Health ’s new Resomer Precise platform of custom functional polymeric excipients reportedly enable pharmaceutical companies to control the release profile of parenteral drug products with a high level of accuracy and precision. According to the company, the line of excipients also will enable users to reach a high degree of product stability, helping reduce regulatory risks.

Andreas Karau, global head of biomaterials for Evonik Health Care, said the company offers a number of benefits to pharmaceutical companies and development partners concerned about product quality and safety.

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 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 company reports the custom excipients offer product specifications as narrow as ± 0.02 dL/g for inherent viscosity (IV), up to 10 times more precise than standard industry polymers used with parenteral drug products. The platform reportedly also delivers favorable levels of accuracy and precision for other key polymer quality attributes including molecular weight and glycolate block length.

The Resomer Precise line is designed for use with more than 20 high and low molecular weight polymers for controlled release formulations from Evonik’s Resomer portfolio; these include PLA (Poly (D,L-lactide) and PLGA (Poly (D,L-lactide-co-glycolide). The manufacturer can supply Resomer Precise grades at lab, clinical or commercial volumes from either of its cGMP facilities in the US and Germany.

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