Evonik's RESOMER® Precise Platform Makes Way for Precise Parenteral Drug Delivery
Evonik announced the launch of the RESOMER® Precise platform of custom functional polymeric excipients to allow pharmaceutical firms to control the release profile of parenteral drug products, leading to a formerly improbable accuracy and precision level.
The company said that this new platform, enabled by a sophisticated process technology, is aimed to help in optimizing the stability of a drug product and, thus, lessen regulatory threat for a variety of complex parenteral drug products.
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Precise Process Technology
Custom excipients that have product specifications, which are as narrow as ± 0.02 dL/g for Inherent Viscosity, or IV, are attainable with RESOMER® Precise, which is in the middle of four and ten times more accurate compared to the standard industry polymers used along with parenteral drug products.
RESOMER® Precise can deliver extraordinary levels of precision and accuracy for other polymer attributes like glycolate block length and molecular weight.
The platform is appropriate for usage with at least 20 high and low molecular weight polymers for controlled release formulations from Evonik's RESOMER® portfolio, which includes Poly D, L-lactide or PLA, and Poly D, L-Lactide-co-glycolide or PLGA.
As in the other RESOMER® and RESOMER® Select polymers, Evonik stated that it could provide RESOMER® Precise grades at the clinical, laboratory, or commercial scale from any of its cGMP facilities located both in the United States and Germany.
Decades of Leadership in the Industry
Global Head of Biomaterials for Evonik Health Care, Dr. Andreas Karau, talked about the capability of Evonik in terms of advances in technology.
"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," he said. "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."
Evonik Health Care is part of Evonik's Nutrition & Care segment that aims to provide services to more than a thousand pharmaceutical, nutraceutical, and medical device consumers globally.
The segment's portfolio of products, services, and technologies help drive the balanced and profitable growth of Evonik.
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Evonik Health Care is part of Evonik's Nutrition & Care segment, providing services to more than a thousand 'pharmaceutical, nutraceutical, and medical device consumers globally.'
A Pharmaceutical Industry Partner
RESOMER® has the leading portfolio for custom, standard, and specialized bioresorbable functional polymers of the world, for employment and application with pharmaceutical drug products, and in implantable medical devices.
Pharmaceutical patrons of Evonik Health Care have access as well to a variety of pharmaceutical ingredients, purposeful excipients, and technologies for drug delivery.
They also have access to both CMO and CDMO services for APIs, excipients, and complex parenteral and oral medicine products.
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