title: Pharmacokinetics of a novel oral slow-release form of misoprostol.
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, requesting surgical abortion were randomly allocated to receive orally 400 microg conventional misoprostol, 400 microg SR misoprostol or 800 microg 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 microg SR misoprostol and significantly greater for these groups compared to 400 microg SR misoprostol (P = 0.013).
  
  
  CONCLUSIONS
  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 microg SR misoprostol was similar to that of 400 microg of conventional oral misoprostol. SR misoprostol may offer an alternative to repeated administration of oral misoprostol or to vaginal administration.
authors.affiliation: Department of Woman and Child Health, Division for Obstetrics and Gynaecology, Karolinska Institutet, S-171 76 Stockholm, Sweden. christian.fiala@aon.at
authors.forename: C
authors.initials: C
authors.lastname: Fiala
authors.forename: A
authors.initials: A
authors.lastname: Aronsson
authors.forename: F
authors.initials: F
authors.lastname: Granath
authors.forename: O
authors.initials: O
authors.lastname: Stephansson
authors.forename: H W
authors.initials: HW
authors.lastname: Seyberth
authors.forename: B
authors.initials: B
authors.lastname: Watzer
authors.forename: K
authors.initials: K
authors.lastname: Gemzell-Danielsson
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000028:Abortion, Induced / Q000379:methods*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D002853:Chromatography, Liquid; D005260:Female; D006801:Humans; D013058:Mass Spectrometry; D016595:Misoprostol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011247:Pregnancy; D013997:Time Factors
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D016595:Misoprostol