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dc.creatorCvijić, Sandra
dc.creatorParojčić, Jelena
dc.creatorIbrić, Svetlana
dc.creatorĐurić, Zorica
dc.date.accessioned2019-09-02T11:24:59Z
dc.date.available2019-09-02T11:24:59Z
dc.date.issued2011
dc.identifier.issn1530-9932
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/1540
dc.description.abstractThe aim of this study was to develop a drug-specific absorption model for gliclazide (GLK) using mechanistic gastrointestinal simulation technology (GIST) implemented in GastroPlus(TM) software package. A range of experimentally determined, in silico predicted or literature data were used as input parameters. Experimentally determined pH-solubility profile was used for all simulations. The human jejunum effective permeability (P (eff)) value was estimated on the basis of in vitro measured Caco-2 permeability (literature data). The required PK inputs were taken from the literature. The results of the simulations were compared with actual clinical data and revealed that the GIST-model gave accurate prediction of gliclazide oral absorption. The generated absorption model provided the target in vivo dissolution profile for in vitro-in vivo correlation and identification of biorelevant dissolution specification for GLK immediate-release (IR) tablets. A set of virtual in vitro data was used for correlation purposes. The obtained results suggest that dissolution specification of more than 85% GLK dissolved in 60 min may be considered as "biorelevant" dissolution acceptance criteria for GLK IR tablets.en
dc.publisherSpringer, New York
dc.relationinfo:eu-repo/grantAgreement/MESTD/MPN2006-2010/23015/RS//
dc.rightsopenAccess
dc.sourceAAPS PharmSciTech
dc.subjectbiorelevant dissolution specificationen
dc.subjectgliclazideen
dc.subjectin vitro-in vivo correlation (IVIVC)en
dc.subjectmechanistic absorption simulationen
dc.titleIn Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulationen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractПаројчић, Јелена; Ђурић, Зорица; Ибрић, Светлана; Цвијић, Сандра;
dc.citation.volume12
dc.citation.issue1
dc.citation.spage165
dc.citation.epage171
dc.citation.other12(1): 165-171
dc.citation.rankM23
dc.identifier.wos000288954100018
dc.identifier.doi10.1208/s12249-010-9573-y
dc.identifier.pmid21181508
dc.identifier.scopus2-s2.0-79954422459
dc.identifier.fulltexthttp://farfar.pharmacy.bg.ac.rs//bitstream/id/394/1538.pdf
dc.identifier.rcubconv_2409
dc.type.versionpublishedVersion


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