Show simple item record

dc.creatorBeloica, Sofija
dc.creatorCvijić, Sandra
dc.creatorHomšek, Irena
dc.creatorBogataj, M.
dc.creatorParojčić, Jelena
dc.date.accessioned2019-09-02T11:47:54Z
dc.date.available2019-09-02T11:47:54Z
dc.date.issued2015
dc.identifier.issn0031-7144
dc.identifier.urihttp://farfar.pharmacy.bg.ac.rs/handle/123456789/2434
dc.description.abstractThe integrated in vitro - in silico - in vivo approach has emerged into a biopharmaceutical toolkit that could accelerate drug development and improve drug product clinical performance in patients. In the present study, the influence of physiologically based media and dynamic dissolution testing on drug release from two metformin hydrochloride immediate release products with proven bioequivalence was tested. Metformin-specific physiologically based pharmacokinetic (PBPK) model was developed based on a range of literature or in silico predicted data using gastrointestinal simulation technology implemented in the Simcyp (R) software package. Various approaches were employed in order to estimate the human effective permeability which was used as input for metformin plasma profile simulation. Influence of the rate and extent of metformin dissolution on drug absorption was evaluated. Both convolution and deconvolution approaches were used in order to establish a correlation between the in vitro and in vivo data. The results obtained indicate that physiologically based dissolution media and glass bead dissolution device exhibit certain advantages over the compendial dissolution apparatus and simple buffers which tended to be over-discriminative. Gastrointestinal simulation technology implemented in the Simcyp (R) Simulator was successfully used in developing drug-specific PBPK model for metformin. Simulations indicate that in vitro dissolution kinetics has no significant effect on metformin absorption, if more than 65% of drug is released in 1 hour. Level A in vitro-in vivo correlation was obtained using both convolution and deconvolution approaches.en
dc.publisherGovi-Verlag Pharmazeutischer Verlag Gmbh, Eschborn
dc.relationinfo:eu-repo/grantAgreement/MESTD/Technological Development (TD or TR)/34007/RS//
dc.rightsrestrictedAccess
dc.sourcePharmazie
dc.titleAn in vitro - in silico - in vivo approach in biopharmaceutical drug characterization: metformin hydrochloride IR tabletsen
dc.typearticle
dc.rights.licenseARR
dcterms.abstractБелоица, Софија; Богатај, М.; Паројчић, Јелена; Цвијић, Сандра; Хомшек, Ирена;
dc.citation.volume70
dc.citation.issue7
dc.citation.spage458
dc.citation.epage465
dc.citation.other70(7): 458-465
dc.citation.rankM23
dc.identifier.wos000358825900004
dc.identifier.doi10.1691/ph.2015.4168
dc.identifier.pmid26373206
dc.identifier.scopus2-s2.0-84940772832
dc.identifier.rcubconv_3356
dc.type.versionpublishedVersion


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record