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Article: A randomized comparison of pharmacokinetics of a single vaginal dose of dry misoprostol or misoprostol moistened with normal saline or with acetic acid

TitleA randomized comparison of pharmacokinetics of a single vaginal dose of dry misoprostol or misoprostol moistened with normal saline or with acetic acid
Authors
Issue Date2011
PublisherOxford University Press. The Journal's web site is located at http://humrep.oxfordjournals.org/
Citation
Human Reproduction, 2011, v. 26 n. 11, p. 2981-2987 How to Cite?
AbstractBACKGROUND: The pharmacokinetics of vaginal misoprostol as a dry tablet or as a tablet moistened with normal saline or with acetic acid were studied. METHODS: For this study, 42 women requesting termination of pregnancy at gestational age of <12 weeks were recruited and received 400 microg vaginal misoprostol tablets. They were randomized into three groups: (i) dry tablets, (ii) tablets moistened with 3 ml of normal saline and (iii) tablets moistened with 3 ml of 5% acetic acid. Venous blood samples were taken at 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min after misoprostol administration. Misoprostol acid (MPA) was determined in serum samples using gas chromatography/tandem mass spectrometry. RESULTS: The serum peak MPA concentration (C(max)) was significantly higher and the time-to-peak concentration (T(max)) was significantly shorter in the normal saline and acetic acid groups, when compared with the dry tablet group. Both areas under the curve at 240 and 360 min (AUC(240) and AUC(360)) of the normal saline and acetic acid groups were also significantly greater than that of the dry tablet group. The coefficients of variation in C(max) and T(max) were highest in the normal saline group, while that of AUC(240) and AUC(360) were highest in the dry tablet group. The C(max) was significantly higher in subjects in the dry tablet group with vaginal pH < 5 than in those with pH 5. There were no significant differences in other pharmacokinetic parameters between subjects with vaginal pH < 5 and those with vaginal pH 5 in all three groups. CONCLUSIONS: Vaginal misoprostol tablets moistened with normal saline or 5% acetic acid achieved better absorption than the dry tablet. The use of vaginal misoprostol tablets moistened with normal saline or 5% acetic acid would potentially improve the clinical efficacy of misoprostol. HKClinicalTrials.com registration: HKCTR-821.
Persistent Identifierhttp://hdl.handle.net/10722/160045
ISSN
2015 Impact Factor: 4.621
2015 SCImago Journal Rankings: 2.271
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLee, VCYen_HK
dc.contributor.authorYung, SSFen_HK
dc.contributor.authorLi, RHWen_HK
dc.contributor.authorWatzer, Ben_HK
dc.contributor.authorSchweer, Hen_HK
dc.contributor.authorNg, EHYen_HK
dc.contributor.authorHo, PCen_HK
dc.date.accessioned2012-08-16T06:01:47Z-
dc.date.available2012-08-16T06:01:47Z-
dc.date.issued2011en_HK
dc.identifier.citationHuman Reproduction, 2011, v. 26 n. 11, p. 2981-2987en_HK
dc.identifier.issn0268-1161en_HK
dc.identifier.urihttp://hdl.handle.net/10722/160045-
dc.description.abstractBACKGROUND: The pharmacokinetics of vaginal misoprostol as a dry tablet or as a tablet moistened with normal saline or with acetic acid were studied. METHODS: For this study, 42 women requesting termination of pregnancy at gestational age of <12 weeks were recruited and received 400 microg vaginal misoprostol tablets. They were randomized into three groups: (i) dry tablets, (ii) tablets moistened with 3 ml of normal saline and (iii) tablets moistened with 3 ml of 5% acetic acid. Venous blood samples were taken at 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min after misoprostol administration. Misoprostol acid (MPA) was determined in serum samples using gas chromatography/tandem mass spectrometry. RESULTS: The serum peak MPA concentration (C(max)) was significantly higher and the time-to-peak concentration (T(max)) was significantly shorter in the normal saline and acetic acid groups, when compared with the dry tablet group. Both areas under the curve at 240 and 360 min (AUC(240) and AUC(360)) of the normal saline and acetic acid groups were also significantly greater than that of the dry tablet group. The coefficients of variation in C(max) and T(max) were highest in the normal saline group, while that of AUC(240) and AUC(360) were highest in the dry tablet group. The C(max) was significantly higher in subjects in the dry tablet group with vaginal pH < 5 than in those with pH 5. There were no significant differences in other pharmacokinetic parameters between subjects with vaginal pH < 5 and those with vaginal pH 5 in all three groups. CONCLUSIONS: Vaginal misoprostol tablets moistened with normal saline or 5% acetic acid achieved better absorption than the dry tablet. The use of vaginal misoprostol tablets moistened with normal saline or 5% acetic acid would potentially improve the clinical efficacy of misoprostol. HKClinicalTrials.com registration: HKCTR-821.en_HK
dc.languageengen_US
dc.publisherOxford University Press. The Journal's web site is located at http://humrep.oxfordjournals.org/en_HK
dc.relation.ispartofHuman Reproductionen_HK
dc.subject.meshAbortifacient Agents, Nonsteroidal - pharmacokineticsen_HK
dc.subject.meshAbortion, Induced - methodsen_HK
dc.subject.meshAcetic Acid - pharmacokineticsen_HK
dc.subject.meshHydrogen-Ion Concentrationen_HK
dc.subject.meshMisoprostol - pharmacokineticsen_HK
dc.titleA randomized comparison of pharmacokinetics of a single vaginal dose of dry misoprostol or misoprostol moistened with normal saline or with acetic aciden_HK
dc.typeArticleen_HK
dc.identifier.emailLee, VCY: v200lee@hku.hken_HK
dc.identifier.emailYung, SSF: ssfyung@hkucc.hku.hken_HK
dc.identifier.emailLi, RHW: raymondli@hku.hken_HK
dc.identifier.emailNg, EHY: nghye@hku.hk-
dc.identifier.emailHo, PC: pcho@hku.hk-
dc.identifier.authorityLi, RHW=rp01649en_HK
dc.identifier.authorityNg, EHY=rp00426en_HK
dc.identifier.authorityHo, PC=rp00325en_HK
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1093/humrep/der303en_HK
dc.identifier.pmid21908466-
dc.identifier.scopuseid_2-s2.0-80054909055en_HK
dc.identifier.hkuros202234en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-80054909055&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume26en_HK
dc.identifier.issue11en_HK
dc.identifier.spage2981en_HK
dc.identifier.epage2987en_HK
dc.identifier.eissn1460-2350-
dc.identifier.isiWOS:000296106600011-
dc.publisher.placeUnited Kingdomen_HK
dc.identifier.scopusauthoridHo, PC=7402211440en_HK
dc.identifier.scopusauthoridNg, EHY=35238184300en_HK
dc.identifier.scopusauthoridSchweer, H=7006657959en_HK
dc.identifier.scopusauthoridWatzer, B=6602418275en_HK
dc.identifier.scopusauthoridLi, RHW=7404724295en_HK
dc.identifier.scopusauthoridYung, SSF=54391873700en_HK
dc.identifier.scopusauthoridLee, VCY=35758969300en_HK

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