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.

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