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dc.creatorKocić, Ivana
dc.creatorHomšek, Irena
dc.creatorDacević, Mirjana
dc.creatorParojčić, Jelena
dc.creatorMiljković, Branislava
dc.date.accessioned2019-09-02T11:23:29Z
dc.date.available2019-09-02T11:23:29Z
dc.date.issued2011
dc.identifier.issn1530-9932
dc.identifier.urihttps://farfar.pharmacy.bg.ac.rs/handle/123456789/1476
dc.description.abstractThe aim of this study was to investigate the influence of experimental conditions on levothyroxine sodium release from two immediate-release tablet formulations which narrowly passed the standard requirements for bioequivalence studies. The in vivo study was conducted as randomised, single-dose, two-way cross-over pharmacokinetic study in 24 healthy subjects. The in vitro study was performed using various dissolution media, and obtained dissolution profiles were compared using the similarity factor value. Drug solubility in different media was also determined. The in vivo results showed narrowly passing bioequivalence. Considering that levothyroxine sodium is classified as Class III drug according to the Biopharmaceutics Classification System, drug bioavailability will be less sensitive to the variation in its dissolution characteristics and it can be assumed that the differences observed in vitro in some of investigated media probably do not have significant influence on the absorption process, as long as rapid and complete dissolution exists. The study results indicate that the current regulatory criteria for the value of similarity factor in comparative dissolution testing, as well as request for very rapid dissolution (more than 85% of drug dissolved in 15 min), are very restricted for immediate-release dosage forms containing highly soluble drug substance and need further investigation. The obtained results also add to the existing debate on the appropriateness of the current bioequivalence standards for levothyroxine sodium products.en
dc.publisherSpringer, New York
dc.relationinfo:eu-repo/grantAgreement/MESTD/Basic Research (BR or ON)/175023/RS//
dc.rightsopenAccess
dc.sourceAAPS PharmSciTech
dc.subjectbioequivalenceen
dc.subjectdissolutionen
dc.subjectimmediate releaseen
dc.subjectlevothyroxine sodiumen
dc.subjectsolubilityen
dc.titleAn Investigation into the Influence of Experimental Conditions on In Vitro Drug Release from Immediate-Release Tablets of Levothyroxine Sodium and Its Relation to Oral Bioavailabilityen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractХомшек, Ирена; Дацевић, Мирјана; Коцић, Ивана; Миљковић, Бранислава; Паројчић, Јелена;
dc.citation.volume12
dc.citation.issue3
dc.citation.spage938
dc.citation.epage948
dc.citation.other12(3): 938-948
dc.citation.rankM23
dc.identifier.wos000294492900016
dc.identifier.doi10.1208/s12249-011-9660-8
dc.identifier.pmid21748540
dc.identifier.scopus2-s2.0-80052568377
dc.identifier.fulltexthttps://farfar.pharmacy.bg.ac.rs//bitstream/id/358/1474.pdf
dc.type.versionpublishedVersion


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Приказ основних података о документу