Influence of alcohol on the release of tramadol from 24-h controlled-release formulations during in vitro dissolution experiments

Abstract

Recent warnings by regulatory bodies and a product recall by the FDA have generated much interest in the area of dose dumping from controlled-release opioid analgesic formulations when coingested with alcohol. It was the aim of this study to address this issue and in doing so, gain understanding on how alcohol-induced effects may be avoided. In this study, tramadol release from Ultram (R) ER tablets and T-long (R) capsules was significantly increased in the presence of ethanol. Conversely, a decrease in the rate of tramadol release was seen from Tridural (TM) extended-release tablets in the presence of alcohol.