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Hum. Reprod. Advance Access published online on July 29, 2005
Human Reproduction, doi:10.1093/humrep/dei229
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.
Received May 19, 2005
Revised June 23, 2005
Accepted June 4, 2005

Article

Pharmacokinetics of a novel oral slow-release form of misoprostol

C. Fiala 1*, A. Aronsson 2, F. Granath 3, O. Stephansson 3, H.W. Seyberth 4, B. Watzer 4, and K. Gemzell-Danielsson 2

1 Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska Institutet, S-171 76 Stockholm, Sweden; Gynmed Ambulatorium, 1150 Vienna, Austria
2 Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska Institutet, S-171 76 Stockholm, Sweden
3 Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, S-171 76 Stockholm, Sweden
4 Department of Pediatrics, Philipps University Marburg, Deutschhausstr, Germany

* To whom correspondence should be addressed.
C. Fiala, E-mail: christian.fiala{at}aon.at


  Abstract

BACKGROUND: The pharmacokinetics of a novel slow-release (SR) misoprostol was studied and compared to conventional misoprostol. METHODS: Thirty-one women, pregnant between 8 and 12 weeks, requestin g surgical abortion were randomly allocated to receive orally 400 µg conventional misoprostol, 400 µg SR misoprostol or 800 µg SR misoprostol. Venous blood samples were taken at 0, 30, 60, 120, 240 and 360 min after the administration of misoprostol. Misoprostol acid (MPA) was determined in serum samples using liquid chromatography/tandem mass spectrometry. RESULTS: Serum peak concentration (Cmax) was highest for conventional oral misoprostol. The time to peak concentration (Tmax) was similar for all groups. The area under the curve up to 360 min was similar for conventional and for 800 µg SR misoprostol and significantly greater for these groups compared to 400 µg SR misoprostol (P = 0.013). CONCLUSION: The new SR form of misoprostol demonstrated lower peak levels but longer-lasting elevation in plasma levels compared to conventional oral misoprostol. The AUC for 800 µg SR misoprostol was similar to that of 400 µg of conventional oral misoprostol. SR misoprostol may offer an alternative to repeated administration of oral misoprostol or to vaginal administration.

Keywords: induced abortion/misoprostol/oral/pharmacokinetics/slow release.
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A. Aronsson, C. Fiala, O. Stephansson, F. Granath, B. Watzer, H. Schweer, and K. Gemzell-Danielsson
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