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Population Pharmacokinetic Analysis of Vaginally and Intravenously Administered Oxytocin in Postmenopausal Women
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden..
Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden..
Swedish Univ Agr Sci, Dept Anim Environm & Hlth, Skara, Sweden..
2017 (English)In: Journal of clinical pharmacology, ISSN 0091-2700, E-ISSN 1552-4604, Vol. 57, no 12, p. 1573-1581Article in journal (Refereed) Published
Abstract [en]

Oxytocin is a neuropeptide hormone used clinically for more than 50 years due to its ability to induce uterine contractions and milk ejection. Vagitocin is a vaginal oxytocin gel developed as a potential treatment of vaginal atrophy in postmenopausal women. The aim of this study was to characterize the oxytocin pharmacokinetics following vaginal and intravenous administration in postmenopausal women. Data from 33 participants enrolled in 2 clinical studies were used in the analysis, with a total of 651 observed oxytocin plasma concentrations, of which 78 were baseline observations, 178 observations following intravenous administration (10 IU), and 395 observations following vaginal administration (100 or 400 IU). The population pharmacokinetics of oxytocin was described using a 2-compartment disposition model with a flexible parallel absorption model accounting for double-peak profiles following vaginal administration. The clearance, volume of distribution at steady state, distribution half-life, and terminal half-life were estimated to be 27 L/h, 15 L, 5.5 minutes, and 1.2 hours, respectively. The bioavailability following vaginal administration was estimated to be 2.5% for the typical patient, but with considerable variability both between individuals (interindividual variability of 374%) and between occasions (interoccasion variability of 79%). The data and the developed model add new and important information as to the clinical pharmacokinetics of oxytocin.

Place, publisher, year, edition, pages
2017. Vol. 57, no 12, p. 1573-1581
Keywords [en]
oxytocin, population pharmacokinetics, postmenopausal women, vaginal gel, bioavailability
National Category
Pharmacology and Toxicology Obstetrics, Gynecology and Reproductive Medicine
Identifiers
URN: urn:nbn:se:uu:diva-341974DOI: 10.1002/jcph.961ISI: 000414973300008PubMedID: 28679021OAI: oai:DiVA.org:uu-341974DiVA, id: diva2:1183832
Available from: 2018-02-19 Created: 2018-02-19 Last updated: 2018-02-19Bibliographically approved

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Nielsen, Elisabet I.

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