Comparative biopharmaceutical performance of imipramine formulations in man

J Clin Pharmacol. 1980 Feb-Mar;20(2-3):151-8. doi: 10.1002/j.1552-4604.1980.tb02537.x.

Abstract

The systemic availability of an investigational liquid formulation of imipramine was compared to that of a commercially available tablet (Tofranil) whose therapeutic efficacy has been established by usage. The experiment was conducted under controlled conditions and a balanced 2-by-2 crossover design was used to dissociate the significance of formulation effects from subject, group, and experimental period sources of variation. Pharmacokinetic interpretation and statistical analysis of plasma concentrations as a function of time and of systemic availability indicators reveal a nearly identical biopharmaceutical behavior for the two preparations. Significant differences (P less than 0.05) were found in the cumulative area under the plasma concentration--time curve (AUC) up to 4 hours after administration and the availability lag time, but not in the maximum plasma concentration, the time at which this concentration is reached, the first-order availability rate constant, and the AUC to infinity. These results collectively indicate a very similar biopharmaceutical performance, where the differences in the early AUC values are partly attributable to a longer availability lag time for the tablet formulation.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Biological Availability
  • Humans
  • Imipramine / administration & dosage*
  • Imipramine / blood
  • Imipramine / metabolism
  • Kinetics
  • Male
  • Solutions
  • Tablets
  • Therapeutic Equivalency

Substances

  • Solutions
  • Tablets
  • Imipramine