Evonik launches new Sterile and Ultra-Low-Metal Content Bioresorbable Polymers

Evonik is expanding its RESOMER portfolio of bioresorbable polymers for controlled-release parenteral drug formulations. It now offers RESOMER Zero and RESOMER Sterile versions of both its standard RESOMER polymers and RESOMER Select customized solutions.

“These additions to our portfolio provide pharmaceutical companies with greater flexibility for their products – while delivering the same high quality, excellent safety profiles, and security of supply they have come to expect from the RESOMER brand,” explains Dr. Thomas Riermeier, responsible for Pharma Polymers and Services within Evonik’s Health Care Business Line.

RESOMER Zero is a premium excipient almost entirely free of tin-based catalyst. This is achieved by means of a proprietary GMP process that essentially eliminates residual tin content (1ppm or less). Consequently, RESOMER Zero is ideal for formulations with APIs sensitive to elemental impurities. Moreover, in contrast to other low-metal polymers, RESOMER Zero provides pharmaceutical companies with a full range of molecular weights and a broad choice of polymer parameters. The polymer properties are designed to minimize degradation during melt processing resulting in improved process control.

RESOMER Sterile is the market’s first and only sterile controlled-release poly (lactic-co-glycolic) acid (PLGA) excipient. This unique grade requires no further sterilization and thus opens up new opportunities for the more flexible and streamlined aseptic manufacturing of parenteral drugs. Evonik’s proprietary sterilization process delivers a very low sterility assurance level (SAL) of 10-6, while fully safeguarding the integrity of the polymers’ properties. In addition, increased bulk densities improve processing performance.

As Dr. Jean-Luc Herbeaux, Head of Evonik’s Health Care Business Line, underscores: “RESOMER Zero and RESOMER Sterile are the latest examples of new and unique Evonik product solutions designed to help our customers tackle complex drug delivery challenges and unlock new value.”

Evonik will highlight the new offering together with its products and service portfolio for drug delivery at its booth (1411) at the 2017 AAPS (American Association of Pharmaceutical Scientists) Annual Meeting and Exposition, in San Diego (California, USA), from November 12 to 15.