Development of physiologically based pharmacokinetic model for the immediate release ropinirole tablets

2021
journal article
article
3
dc.abstract.enRopinirole is a dopamine receptor agonist with high inter-individual variability in pharma- cokinetic parameters. Physiologically based pharmacokinetic (PBPK) modeling allows predicting drug pharmacokinetic behavior while accounting for individual demographic and physiological parameters. Considering that ropinirole is used in patients of different ages and disease states, a PBPK model could be of potential use in informing clinical trials or new formulation development. The aim of this study was to develop a PBPK model for ropinirole and investigate whether the developed model will be able to predict pharmacokinetics in patient populations. Within this paper, a PBPK model for the immediate release ropinirole tablets was developed and verified against observed data from 11 clinical trials. The model reasonably predicted pharmacokinetics of ropinirole in healthy volunteers and patient populations. Predicted ropinirole PK parameters were within 2-fold of the observed values. The model is able to predict ropinirole pharmacokinetics in healthy volunteers, Parkinson’s disease patients, and restless legs syndrome patients.
dc.affiliationWydział Farmaceutyczny : Zakład Farmacji Społecznejpl
dc.affiliationSzkoła Doktorska Nauk Medycznych i Nauk o Zdrowiupl
dc.cm.date2021-09-01
dc.cm.id105446
dc.cm.idOmegaUJCM85c48df7cc544aa6b524a36de97814ccpl
dc.contributor.authorShuklinova, Olha - 403594 pl
dc.contributor.authorDorożyński, Przemysław - 129211 pl
dc.contributor.authorKulinowski, Piotrpl
dc.contributor.authorBielecka, Zofia - 163802 pl
dc.contributor.authorWiśniowska, Barbara - 148047 pl
dc.contributor.authorPolak, Sebastian - 133197 pl
dc.date.accession2022-02-01pl
dc.date.accessioned2021-09-01T07:52:19Z
dc.date.available2021-09-01T07:52:19Z
dc.date.issued2021pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.number3pl
dc.description.physical317-328pl
dc.description.points70
dc.description.versionostateczna wersja wydawcy
dc.description.volume78pl
dc.identifier.doi10.32383/appdr/137903pl
dc.identifier.eissn2353-5288pl
dc.identifier.issn0001-6837pl
dc.identifier.projectROD UJ / Opl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/277943
dc.identifier.weblinkhttps://ptfarm.pl/wydawnictwa/czasopisma/acta-poloniae-pharmaceutica/110/-/29108pl
dc.languageengpl
dc.language.containerengpl
dc.pbn.affiliationDziedzina nauk medycznych i nauk o zdrowiu : nauki farmaceutyczne
dc.relation.uri*
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 4.0 Międzynarodowa
dc.rights.licenceCC-BY-NC
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/legalcode.pl
dc.share.typeOtwarte czasopismo
dc.subject.enropinirole
dc.subject.enphysiologically based pharmacokinetic modeling
dc.subject.enParkinson’s disease
dc.subtypeArticlepl
dc.titleDevelopment of physiologically based pharmacokinetic model for the immediate release ropinirole tabletspl
dc.title.journalActa Poloniae Pharmaceuticapl
dc.typeJournalArticlepl
dspace.entity.typePublication
dc.abstract.en
Ropinirole is a dopamine receptor agonist with high inter-individual variability in pharma- cokinetic parameters. Physiologically based pharmacokinetic (PBPK) modeling allows predicting drug pharmacokinetic behavior while accounting for individual demographic and physiological parameters. Considering that ropinirole is used in patients of different ages and disease states, a PBPK model could be of potential use in informing clinical trials or new formulation development. The aim of this study was to develop a PBPK model for ropinirole and investigate whether the developed model will be able to predict pharmacokinetics in patient populations. Within this paper, a PBPK model for the immediate release ropinirole tablets was developed and verified against observed data from 11 clinical trials. The model reasonably predicted pharmacokinetics of ropinirole in healthy volunteers and patient populations. Predicted ropinirole PK parameters were within 2-fold of the observed values. The model is able to predict ropinirole pharmacokinetics in healthy volunteers, Parkinson’s disease patients, and restless legs syndrome patients.
dc.affiliationpl
Wydział Farmaceutyczny : Zakład Farmacji Społecznej
dc.affiliationpl
Szkoła Doktorska Nauk Medycznych i Nauk o Zdrowiu
dc.cm.date
2021-09-01
dc.cm.id
105446
dc.cm.idOmegapl
UJCM85c48df7cc544aa6b524a36de97814cc
dc.contributor.authorpl
Shuklinova, Olha - 403594
dc.contributor.authorpl
Dorożyński, Przemysław - 129211
dc.contributor.authorpl
Kulinowski, Piotr
dc.contributor.authorpl
Bielecka, Zofia - 163802
dc.contributor.authorpl
Wiśniowska, Barbara - 148047
dc.contributor.authorpl
Polak, Sebastian - 133197
dc.date.accessionpl
2022-02-01
dc.date.accessioned
2021-09-01T07:52:19Z
dc.date.available
2021-09-01T07:52:19Z
dc.date.issuedpl
2021
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.numberpl
3
dc.description.physicalpl
317-328
dc.description.points
70
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
78
dc.identifier.doipl
10.32383/appdr/137903
dc.identifier.eissnpl
2353-5288
dc.identifier.issnpl
0001-6837
dc.identifier.projectpl
ROD UJ / O
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/277943
dc.identifier.weblinkpl
https://ptfarm.pl/wydawnictwa/czasopisma/acta-poloniae-pharmaceutica/110/-/29108
dc.languagepl
eng
dc.language.containerpl
eng
dc.pbn.affiliation
Dziedzina nauk medycznych i nauk o zdrowiu : nauki farmaceutyczne
dc.relation.uri*
dc.rights
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 4.0 Międzynarodowa
dc.rights.licence
CC-BY-NC
dc.rights.uri
http://creativecommons.org/licenses/by-nc/4.0/legalcode.pl
dc.share.type
Otwarte czasopismo
dc.subject.en
ropinirole
dc.subject.en
physiologically based pharmacokinetic modeling
dc.subject.en
Parkinson’s disease
dc.subtypepl
Article
dc.titlepl
Development of physiologically based pharmacokinetic model for the immediate release ropinirole tablets
dc.title.journalpl
Acta Poloniae Pharmaceutica
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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