Kees, Frieder and Jehkul, Andreas and Bucher, Michael and Mair, Georg and Kiermaier, Josef and Grobecker, Horst (2003) Bioavailability of opipramol from a film-coated tablet, a sugar-coated tablet and an aqueous solution in healthy volunteers. ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH, 53 (2). pp. 87-92. ISSN 0004-4172
Full text not available from this repository.Abstract
Opipramol (4-[3-(5H-dibenz[b,f]-azepine5-yl)-propyl]-1-piperazine-ethanol dihydrochloride, CAS 315-72-0) is regarded as an anxiolytic compound with antidepressant properties, and it is one of the most frequently prescribed psychotropic drugs in Germany. In two open, randomized cross-over studies in 20 (study 1) and 18 (study 11) healthy volunteers, the relative bioavailability of 50 mg opipramol-2HCl from a sugar-coated tablet was compared with an aqueous solution, and of 100 mg opipramol-2HCl from a newly developed film-coated tablet was compared with the sugar-coated tablet. The concentrations of opipramol were determined in plasma by high-performance liquid chromatography (HPLC) with photometric detection. The mean dose corrected kinetic parameters of opipramol were similar after administration of all formulations. The peak concentrations of opipramol were 13-15 ng ml(-1) (study I) and 28 ng ml-1 (study II). They were achieved after 3 h. The area under the plasma concentration-time curve was about 170 ng ml-1 h (study I) and about 320 ng ml(-1) h (study II). The terminal plasma half-life was 11 h. Bioequivalence was proven between sugar-coated tablet and aqueous solution, and between film-coated tablet and sugar-coated tablet, respectively. In addition, in study II the plasma concentrations and pharmacokinetic parameters of the metabolites opipramol N-oxide and deshydroxyethyl opipramol were determined.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PLASMA; CAS 315-72-0; Insidon (R); opipramol, aqueous solution, bioequivalence, film-coated tablet, sugar-coated tabler |
| Subjects: | 600 Technology > 615 Pharmacy |
| Divisions: | Medicine > Lehrstuhl für Anästhesiologie Chemistry and Pharmacy > Institute of Pharmacy > Alumni or Retired Professors > Prof. Frieder Kees Chemistry and Pharmacy > Central Analytical Services |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Aug 2021 13:50 |
| Last Modified: | 24 Aug 2021 13:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/39400 |
Actions (login required)
 |
View Item |
