METHODS OF REDUCING ALCOHOL-INDUCED DOSE DUMPING FOR OPIOID SUSTAINED RELEASE ORAL DOSAGE FORMS

摘要

Oral dosage form comprises an opioid and a dosing structure that provides extended release of the opioid in the presence of aqueous alcohol with an alcohol concentration of at least 20 vol.%, such that the ratio of the mean unit dose maximum opioid plasma concentration with alcohol coadminstration to the mean unit dose maximum opioid plasma concentration without alcohol co-adminstration is no more than 1.8:1. Independent claims are also included for: (1) oral dosage form comprising an opioid and a dosing structure that provides extended release of the opioid in the presence of aqueous alcohol with an alcohol concentration of at least 20 vol.%, such that the ratio of an individual patient unit dose maximum opioid plasma concentration with alcohol coadminstration to the individual unit dose maximum opioid plasma concentration without alcohol coadminstration is no more than 5:1; (2) oral dosage form comprising an opioid and a dosing structure that provides extended release of the opioid in the presence of aqueous alcohol with an alcohol concentration of at least 20 vol.%, such that no more than 80% of the dose is released in 2 hours in an in-vitro test performed in the presence of at least 20 vol.% alcohol. ACTIVITY : Analgesic. MECHANISM OF ACTION : None given.