Evonik is expanding its RESOMER portfolio of bioresorbable polymers for controlled-release parenteral drug formulations, offering RESOMER Zero and RESOMER Sterile versions of its standard andSelect 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,” said, 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, according to the company. This is achievedusing a GMP process that essentially eliminates residual tin content (1ppm or less), making itideal for formulations with APIs sensitive to elemental impurities. Also, RESOMER Zero provides a full range of molecular weights and choice of polymer parameters. The polymer properties are designed to minimize degradation during melt processing resulting in improved process control.

Also, according to the company, RESOMER Sterile is the market’s first and only sterile controlled-release poly (lactic-co-glycolic) acid (PLGA) excipient. This grade requires no further sterilization providing a more flexible and streamlined aseptic manufacturing of parenteral drugs. Evonik’s sterilization process aims to deliver a very low sterility assurance level (SAL) of 10-6, while safeguarding the integrity of the polymers’ properties. Also, increased bulk densities help to improve processing performance.

Dr. Jean-Luc Herbeaux, head of Evonik’s Health Care Business Line, said, “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 at booth 1411 at AAPS.