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

Drug Dev Ind Pharm. 2008 Aug;34(8):885-9. doi: 10.1080/03639040801929240.

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 ER tablets and T-long capsules was significantly increased in the presence of ethanol. Conversely, a decrease in the rate of tramadol release was seen from Tridural extended-release tablets in the presence of alcohol.

MeSH terms

  • Analgesics, Opioid / administration & dosage
  • Analgesics, Opioid / pharmacokinetics*
  • Capsules
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Ethanol / administration & dosage
  • Ethanol / pharmacology*
  • Half-Life
  • Tablets
  • Tramadol / administration & dosage
  • Tramadol / pharmacokinetics*

Substances

  • Analgesics, Opioid
  • Capsules
  • Delayed-Action Preparations
  • Tablets
  • Tramadol
  • Ethanol