dc.creator | Cvijić, Sandra | |
dc.creator | Parojčić, Jelena | |
dc.creator | Ibrić, Svetlana | |
dc.creator | Đurić, Zorica | |
dc.date.accessioned | 2019-09-02T11:24:59Z | |
dc.date.available | 2019-09-02T11:24:59Z | |
dc.date.issued | 2011 | |
dc.identifier.issn | 1530-9932 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/1540 | |
dc.description.abstract | The 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.publisher | Springer, New York | |
dc.relation | info:eu-repo/grantAgreement/MESTD/MPN2006-2010/23015/RS// | |
dc.rights | openAccess | |
dc.source | AAPS PharmSciTech | |
dc.subject | biorelevant dissolution specification | en |
dc.subject | gliclazide | en |
dc.subject | in vitro-in vivo correlation (IVIVC) | en |
dc.subject | mechanistic absorption simulation | en |
dc.title | In Vitro-In Vivo Correlation for Gliclazide Immediate-Release Tablets Based on Mechanistic Absorption Simulation | en |
dc.type | article | |
dc.rights.license | ARR | |
dcterms.abstract | Паројчић, Јелена; Ђурић, Зорица; Ибрић, Светлана; Цвијић, Сандра; | |
dc.citation.volume | 12 | |
dc.citation.issue | 1 | |
dc.citation.spage | 165 | |
dc.citation.epage | 171 | |
dc.citation.other | 12(1): 165-171 | |
dc.citation.rank | M23 | |
dc.identifier.wos | 000288954100018 | |
dc.identifier.doi | 10.1208/s12249-010-9573-y | |
dc.identifier.pmid | 21181508 | |
dc.identifier.scopus | 2-s2.0-79954422459 | |
dc.identifier.fulltext | https://farfar.pharmacy.bg.ac.rs//bitstream/id/394/1538.pdf | |
dc.type.version | publishedVersion | |