Evonik launches new sterile and ultra-low-metal content bioresorbable polymers
- RESOMER® ZERO is an ultra-low tin content PLGA excipient
- RESOMER® Sterile is the first sterile controlled release poly(lactic-co-glycolic) (PLGA) excipient in the market
- Customers will continue to enjoy the quality and security of supply of the RESOMER® product portfolio, now with greater flexibility and choice
Evonik, a global leader in biomaterials, 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.
Evonik is one of the world leaders in specialty chemicals. The focus on more specialty businesses, customer-orientated innovative prowess and a trustful and performance-oriented corporate culture form the heart of Evonik’s corporate strategy. They are the lever for profitable growth and a sustained increase in the value of the company. Evonik benefits specifically from its customer proximity and leading market positions. Evonik is active in over 100 countries around the world with more than 36,000 employees. In fiscal 2016, the enterprise generated sales of around €12.7 billion and an operating profit (adjusted EBITDA) of about €2.165 billion.
About Nutrition & Care
The Nutrition & Care segment is led by Evonik Nutrition & Care GmbH and contributes to fulfilling basic human needs. That includes applications for everyday consumer goods as well as animal nutrition and health care. This segment employed about 7,500 employees, and generated sales of around
€4.3 billion in 2016.
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.