Enantioselective pharmacokinetics in animals of pazinaclone, a new isoindoline anxiolytic, and its active metabolite

Biopharm Drug Dispos. 1995 Dec;16(9):755-73. doi: 10.1002/bdd.2510160906.

Abstract

The enantioselective pharmacokinetics of a new anxiolytic, pazinaclone (DN-2327), and its active metabolite, M-II, were studied in animals. In rats and dogs given racemic pazinaclone intravenously, the total clearance and volume of distribution of (S)-pazinaclone were lower than those of (R)-pazinaclone, whereas the opposite results were obtained in monkeys. The differences in disposition were consistent with enantioselective protein binding, where the unbound fraction was greater for (R)-pazinaclone than that for the (S)-enantiomer in rats and dogs; the reverse was noted in monkeys. Lower clearance and distribution for (S)-pazinaclone in rats and dogs, and for the (R)-enantiomer in monkeys, resulted in comparable plasma profiles for the pazinaclone enantiomers and thereby those of the corresponding enantiomers of M-II. The unbound clearance (CLu) of (S)-pazinaclone was, however, greater than that of the antipode in rats and dogs and the CLu of each enantiomer was similar in monkeys. Thus, enantioselectivity in the kinetics of (S)- and (R)-pazinaclone appears to reside largely in plasma binding differences and is unrelated to variations in intrinsic clearance. The first-pass metabolism of (S)- and (R)-pazinaclone on oral administration of the racemate was enantioselective, with respective bioavailabilities of 1.7 and 0.8% in rats, 10.4 and 1.9% in dogs, and 0 and 11.4% in monkeys. Therefore, the enantioselectivity was more pronounced after oral dosing.

Publication types

  • Comparative Study

MeSH terms

  • Absorption
  • Administration, Oral
  • Analysis of Variance
  • Animals
  • Anti-Anxiety Agents / administration & dosage
  • Anti-Anxiety Agents / blood
  • Anti-Anxiety Agents / pharmacokinetics*
  • Biological Availability
  • Blood Proteins / metabolism
  • Chromatography, High Pressure Liquid
  • Chromatography, Thin Layer
  • Dogs
  • Erythrocytes / metabolism
  • Injections, Intravenous
  • Isoindoles
  • Macaca fascicularis
  • Male
  • Naphthyridines / administration & dosage
  • Naphthyridines / blood
  • Naphthyridines / pharmacokinetics*
  • Protein Binding
  • Rats
  • Rats, Wistar
  • Species Specificity
  • Spiro Compounds / administration & dosage
  • Spiro Compounds / blood
  • Spiro Compounds / pharmacokinetics*
  • Stereoisomerism
  • Tissue Distribution

Substances

  • Anti-Anxiety Agents
  • Blood Proteins
  • Isoindoles
  • Naphthyridines
  • Spiro Compounds
  • pazinaclone