Intravenous buprenorphine and norbuprenorphine pharmacokinetics in humans

Drug Alcohol Depend. 2013 Aug 1;131(3):258-62. doi: 10.1016/j.drugalcdep.2012.11.014. Epub 2012 Dec 14.

Abstract

Background: Prescribed sublingual (SL) buprenorphine is sometimes diverted for intravenous (IV) abuse, but no human pharmacokinetic data are available following high-dose IV buprenorphine.

Methods: Plasma was collected for 72 h after administration of placebo or 2, 4, 8, 12, or 16 mg IV buprenorphine in escalating order (single-blind, double-dummy) in 5 healthy male non-dependent opioid users. Buprenorphine and its primary active metabolite, norbuprenorphine, were quantified by liquid chromatography-tandem mass spectrometry with limits of quantitation of 0.1 μg/L.

Results: Maximum buprenorphine concentrations (mean ± SE) were detected 10 min after 2, 4, 8, 12, 16 mg IV: 19.3 ± 1.0, 44.5 ± 4.8, 85.2 ± 7.7, 124.6 ± 16.6, and 137.7 ± 18.8 μg/L, respectively. Maximum norbuprenorphine concentrations occurred 10-15 min (3.7 ± 0.7 μg/L) after 16 mg IV administration.

Conclusions: Buprenorphine concentrations increased in a significantly linear dose-dependent manner up to 12 mg IV buprenorphine. Thus, previously demonstrated pharmacodynamic ceiling effects (over 2-16 mg) are not due to pharmacokinetic adaptations within this range, although they may play a role at doses higher than 12 mg.

Keywords: Buprenorphine; Intravenous; Norbuprenorphine; Pharmacokinetics.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Intramural

MeSH terms

  • Adult
  • Buprenorphine / administration & dosage*
  • Buprenorphine / analogs & derivatives*
  • Buprenorphine / blood
  • Buprenorphine / pharmacokinetics*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Humans
  • Infusions, Intravenous
  • Male
  • Single-Blind Method

Substances

  • Buprenorphine
  • norbuprenorphine