Alcohol resistant dosage forms

摘要

PROBLEM TO BE SOLVED: To provide an opioid release controlling formulation resistant to an alcohol extraction of opioid.SOLUTION: In a specific dosage form, a ratio of the amount of opioid analgesia drug salt released after one-hour in vitro melting of the dosage form in either 500 ml or 900 ml artificial gastric fluid each containing 20% ethanol, using USP Apparatus I (basket) device at 100 rpm and 37°C, to the amount of opioid analgesia drug salt discharged after one-hour in vitro melting of the dosaage form in either 500 ml or 900 ml artificial gastric fluid each containing 0% ethanol, using USP Apparatus I (basket) device at 100 rpm and 37°C is about 2 : 1 or less.