Evonik has developed a formulation technology, which offers a novel approach to developing alcohol resistant oral drug products with delayed or sustained release profiles. EUDRATEC™ ADD delivers a solution to the problem of alcohol-induced dose dumping of modified release dosage forms and enables the pharmaceutical industry to be in accordance with the sharpened requirements of the US-FDA.
If patients take oral drugs, designed with a modified release (MR) profile, together with alcohol, the potential exists for an increased and/or uncontrolled release of the drug’s active ingredient (dose dumping) in the stomach, as current tablet coating systems dissolve in alcohol. The resulting release burst and associated high concentration of the active ingredient has the potential to be harmful to patients. For example, in the case of sustained release opioids designed to treat pain for 12 hours, patients may be subjected to a 12-hour dose in a matter of minutes.
Recognizing the problem, regulatory agencies have issued guidelines for the evaluation of MR formulations through in vitro alcohol testing. These guidelines pose significant technological challenges to formulators as current drug coating formulations do not perform in the presence of alcohol.
Acknowledging the need for new solutions, Evonik has developed EUDRATEC™ ADD, a new formulation technology consisting of a bilayer coating with EUDRAGIT® polymers, which allow formulators to achieve the same release profiles in a 40% alcoholic medium (equivalent to pure whisky or vodka) as in an aqueous medium. EUDRATEC™ ADD is patent protected and has demonstrated its effectiveness for use with drugs designed for both, targeted or sustained release profiles.
"EUDRATEC™ ADD is a great demonstrator of Evonik’s innovation power in oral drug product formulation", states Dr. Jean-Luc Herbeaux, Head of the Health Care Business Line of Evonik. He expects, that this new technology will generate new EUDRAGIT® product and service sales as well as licensing revenues in the next years. "EUDRATEC™ ADD has created a lot of interest at pharma companies since it was first introduced in tradeshows late last year." Adds Herbeaux.
EUDRATEC® ADD will be available in all formulation centers of Evonik around the world. It is the first technology of the new EUDRATEC™ technology platform. The platform will be further expanded to address unmet customer formulation needs in the oral drug space.
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals, operating in the Nutrition & Care, Resource Efficiency and Performance Materials segments. The company benefits from its innovative prowess and integrated technology platforms. In 2015 more than 33,500 employees generated sales of around €13.5 billion and an operating profit (adjusted EBITDA) of about €2.47 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 7,000 employees, and generated sales of around
€4.9 billion in 2015.
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.