Hum. Reprod. Advance Access originally published online on May 8, 2007
Human Reproduction 2007 22(7):1912-1918; doi:10.1093/humrep/dem098
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Pharmacokinetic profiles up to 12 h after administration of vaginal, sublingual and slow-release oral misoprostol
1 Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska University Hospital, Karolinska Institutet, SE-171 76 Stockholm, Sweden 2 Department of Medical Epidemiology and Biostatistics, Karolinska University Hospital, Karolinska Institutet, SE-171 76 Stockholm, Sweden 3 Gynmed Clinic, Vienna, Austria 4 Department of Pediatrics, Philipps University Marburg, Marburg, Germany
5 Correspondence address. Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska Institutet/Karolinska University Hospital, SE-171 76 Stockholm, Sweden. Tel: +46 8 51772128; Fax: +4651774314; E-mail: annette.aronsson{at}karolinska.se
BACKGROUND: It has been shown that the route of administration of misoprostol has a strong impact on the pharmacokinetic profile and result in different clinical efficacy. No study has so far evaluated the pharmacokinetics beyond 6 hours. Furthermore a new slow-release misoprostol formulation was included in the study.
METHODS: Pharmacokinetics of a novel slow-release (SR) oral misoprostol was compared during 12 h after administration to conventional misoprostol administered vaginally or sublingually. Thirty-three women requesting surgical abortion up to 12 weeks were randomly allocated to groups receiving a single dose of 400 µg conventional misoprostol administered vaginally or sublingually or 800 µg SR oral misoprostol. Blood samples were taken before (0 h) and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 h after misoprostol administration. Misoprostol acid (MPA) was determined in serum samples using liquid chromatography/tandem mass spectrometry.
RESULTS: Three women did not complete the study. Serum concentrations reached their highest level following sublingual misoprostol (P < 0.0001) and the time to peak concentration was shortest for this group (P = 0.0094). The area under the curve (AUC) up to 12 h was greater following sublingual treatment than for the other alternatives (P < 0.0001) and lowest for SR misoprostol. Cumulative serum levels of MPA did not increase beyond 6 h following sublingual and vaginal administration, while they continued to increase up to 12 h following SR misoprostol. CONCLUSIONS: The new SR form of misoprostol demonstrated lower peak levels and a lower AUC but longer lasting elevation in serum levels when compared to conventional misoprostol administered sublingually or vaginally. SR misoprostol may offer an alternative to repeated administration of conventional misoprostol.
Key words: induced abortion/misoprostol/pharmacokinetics/slow release
Submitted on February 4, 2007; resubmitted on March 7, 2007; accepted on March 27, 2007.
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  O. S. Tang, H. Schweer, S. W.H. Lee, and P. C. Ho Pharmacokinetics of repeated doses of misoprostol Hum. Reprod., April 23, 2009; (2009) dep108v1. [Abstract] [Full Text] [PDF]
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