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Article: Preclinical evaluation of pharmacokinetics and safety of melatonin in propylene glycol for intravenous administration

TitlePreclinical evaluation of pharmacokinetics and safety of melatonin in propylene glycol for intravenous administration
Authors
KeywordsBiochemistry
Hematology
Histology
Melatonin
Pharmacokinetics
Rats
Issue Date2006
PublisherBlackwell Munksgaard. The Journal's web site is located at http://www.blackwellpublishing.com/journals/JPI
Citation
Journal Of Pineal Research, 2006, v. 41 n. 4, p. 337-343 How to Cite?
AbstractMelatonin is a highly effective treatment in different animal models of excitotoxicity or ischemia/reperfusion injury. Due to a lack of patentability, commercial sponsors are not interested in funding clinical evaluations of melatonin. Investigators may initiate small-scale clinical evaluation, and intravenous (i.v.) administration is appropriate in acute stroke patients. Institutional Review Boards may require proper preclinical evaluation of the preparation. In this pharmacokinetic and safety study, melatonin in propylene glycol was evaluated in adult male Sprague-Dawley rats. Following a single i.v. injection at 5 or 15 mg/kg, plasma concentrations of melatonin increased to 39 and 199 million pg/mL at 2 min and 128 000 and 772 000 pg/mL at 120 min. Within 60 min of injection, the blood pressure, heart rate and body temperature remained unaffected. Melatonin at 5 mg/kg did not influence the complete blood counts at 60 min, but melatonin at 15 mg/kg had some effects on the differential white cell and platelet counts. Melatonin at 5 or 15 mg/kg slightly elevated some liver enzymes at 60 min of injection, and melatonin at higher dose also elevated plasma creatinine and lactate dehydrogenase levels. At 24 hr after completion of six daily injections of melatonin, there was a 5.5% reduction in body weight. Gross postmortem examination and histological examination of the brain, kidney, liver and spleen did not reveal any evidence of toxicity. In conclusion, melatonin in propylene glycol markedly elevates plasma levels of melatonin with no serious toxicity. This preparation should be further evaluated in human patients. © 2006 The Authors.
Persistent Identifierhttp://hdl.handle.net/10722/67447
ISSN
2015 Impact Factor: 9.314
2015 SCImago Journal Rankings: 2.655
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorCheung, RTFen_HK
dc.contributor.authorTipoe, GLen_HK
dc.contributor.authorTam, Sen_HK
dc.contributor.authorMa, ESKen_HK
dc.contributor.authorZou, LYen_HK
dc.contributor.authorChan, PSen_HK
dc.date.accessioned2010-09-06T05:55:13Z-
dc.date.available2010-09-06T05:55:13Z-
dc.date.issued2006en_HK
dc.identifier.citationJournal Of Pineal Research, 2006, v. 41 n. 4, p. 337-343en_HK
dc.identifier.issn0742-3098en_HK
dc.identifier.urihttp://hdl.handle.net/10722/67447-
dc.description.abstractMelatonin is a highly effective treatment in different animal models of excitotoxicity or ischemia/reperfusion injury. Due to a lack of patentability, commercial sponsors are not interested in funding clinical evaluations of melatonin. Investigators may initiate small-scale clinical evaluation, and intravenous (i.v.) administration is appropriate in acute stroke patients. Institutional Review Boards may require proper preclinical evaluation of the preparation. In this pharmacokinetic and safety study, melatonin in propylene glycol was evaluated in adult male Sprague-Dawley rats. Following a single i.v. injection at 5 or 15 mg/kg, plasma concentrations of melatonin increased to 39 and 199 million pg/mL at 2 min and 128 000 and 772 000 pg/mL at 120 min. Within 60 min of injection, the blood pressure, heart rate and body temperature remained unaffected. Melatonin at 5 mg/kg did not influence the complete blood counts at 60 min, but melatonin at 15 mg/kg had some effects on the differential white cell and platelet counts. Melatonin at 5 or 15 mg/kg slightly elevated some liver enzymes at 60 min of injection, and melatonin at higher dose also elevated plasma creatinine and lactate dehydrogenase levels. At 24 hr after completion of six daily injections of melatonin, there was a 5.5% reduction in body weight. Gross postmortem examination and histological examination of the brain, kidney, liver and spleen did not reveal any evidence of toxicity. In conclusion, melatonin in propylene glycol markedly elevates plasma levels of melatonin with no serious toxicity. This preparation should be further evaluated in human patients. © 2006 The Authors.en_HK
dc.languageengen_HK
dc.publisherBlackwell Munksgaard. The Journal's web site is located at http://www.blackwellpublishing.com/journals/JPIen_HK
dc.relation.ispartofJournal of Pineal Researchen_HK
dc.subjectBiochemistryen_HK
dc.subjectHematologyen_HK
dc.subjectHistologyen_HK
dc.subjectMelatoninen_HK
dc.subjectPharmacokineticsen_HK
dc.subjectRatsen_HK
dc.subject.meshAnimalsen_HK
dc.subject.meshBlood Cell Counten_HK
dc.subject.meshBlood Pressure - drug effectsen_HK
dc.subject.meshBody Temperature - drug effectsen_HK
dc.subject.meshBody Weight - drug effectsen_HK
dc.subject.meshBrain - drug effectsen_HK
dc.subject.meshDrug Evaluation, Preclinicalen_HK
dc.subject.meshDrug Toxicityen_HK
dc.subject.meshHeart Rate - drug effectsen_HK
dc.subject.meshInjections, Intravenousen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMelatonin - administration & dosage - adverse effects - blood - pharmacokineticsen_HK
dc.subject.meshPropylene Glycolen_HK
dc.subject.meshRatsen_HK
dc.subject.meshRats, Sprague-Dawleyen_HK
dc.titlePreclinical evaluation of pharmacokinetics and safety of melatonin in propylene glycol for intravenous administrationen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0742-3098&volume=41&spage=337&epage=343&date=2006&atitle=Preclinical+evaluation+of+pharmacokinetics+and+safety+of+melatonin+in+propylene+glycol+for+intravenous+administrationen_HK
dc.identifier.emailCheung, RTF:rtcheung@hku.hken_HK
dc.identifier.emailTipoe, GL:tgeorge@hkucc.hku.hken_HK
dc.identifier.authorityCheung, RTF=rp00434en_HK
dc.identifier.authorityTipoe, GL=rp00371en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1111/j.1600-079X.2006.00372.xen_HK
dc.identifier.pmid17014690-
dc.identifier.scopuseid_2-s2.0-33749356167en_HK
dc.identifier.hkuros124933en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-33749356167&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume41en_HK
dc.identifier.issue4en_HK
dc.identifier.spage337en_HK
dc.identifier.epage343en_HK
dc.identifier.eissn1600-079X-
dc.identifier.isiWOS:000240921200005-
dc.publisher.placeDenmarken_HK
dc.identifier.scopusauthoridCheung, RTF=7202397498en_HK
dc.identifier.scopusauthoridTipoe, GL=7003550610en_HK
dc.identifier.scopusauthoridTam, S=7202037323en_HK
dc.identifier.scopusauthoridMa, ESK=7202039934en_HK
dc.identifier.scopusauthoridZou, LY=23391539300en_HK
dc.identifier.scopusauthoridChan, PS=12788250500en_HK
dc.identifier.citeulike883650-

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