Toward the establishment of a standardized pre-clinical porcine model to predict food effects - case studies on Fenofibrate and Paracetamol

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dc.contributor.authorHenze, Laura J.
dc.contributor.authorKoehl, Niklas J.
dc.contributor.authorO'Shea, Joseph P.
dc.contributor.authorHolm, René
dc.contributor.authorVertzoni, Maria
dc.contributor.authorGriffin, Brendan T.
dc.contributor.funderHorizon 2020en
dc.date.accessioned2019-05-29T11:13:46Z
dc.date.available2019-05-29T11:13:46Z
dc.date.issued2019-05-28
dc.date.updated2019-05-29T11:07:44Z
dc.description.abstractA preclinical porcine model that reliably predicts human food effect of fenofibrate was developed. Fenofibrate was administered to pigs as model compound with a positive food effect. Two different types of fed conditions were explored: a FDA style breakfast and a standard pig pellet feed. In order to assess if complete stomach emptying had been achieved under the employed fasting protocol, the amount of gastric and intestinal content was evaluated post-mortem. In addition, the protocol was designed to evaluate gastric emptying in the pre- and postprandial state using paracetamol as a marker. The study confirmed that micronized fenofibrate displayed a positive food effect with a similar fold difference to humans in FDA style fed state. Post-mortem assessment of stomach and intestinal content confirmed significantly lower content in the fasted compared to the pig pellet fed state. In the case of paracetamol, a delayed gastric emptying in the fed state was not observed, which may suggest that the Magenstrasse phenomena reported in humans, may also occur in landrace pigs. The study demonstrated the utility of a food effect protocol in landrace pigs as a pre-clinical approach to predict human food effects and provided new insights into gastric emptying in pigs.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid100017en
dc.identifier.citationHenze, L. J., Koehl, N. J., O'Shea, J. P., Holm, R., Vertzoni, M. and Griffin, B. T. (2019) 'Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol', International Journal of Pharmaceutics: X, 1, pp. 100017. doi: 10.1016/j.ijpx.2019.100017en
dc.identifier.doi10.1016/j.ijpx.2019.100017en
dc.identifier.endpage9en
dc.identifier.issn2590-1567
dc.identifier.journaltitleInternational Journal Of Pharmaceutics: Xen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/7997
dc.language.isoenen
dc.publisherElsevieren
dc.relation.projectinfo:eu-repo/grantAgreement/EC/H2020::MSCA-ITN-ETN/674909/EU/Pharmaceutical Education And Research with Regulatory Links: Innovative drug development strategies and regulatory tools tailored to facilitate earlier access to medicines/PEARRLen
dc.relation.urihttp://www.sciencedirect.com/science/article/pii/S2590156719300313
dc.rights© 2019 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND licenseen
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.subjectLandrace pigsen
dc.subjectMinipigsen
dc.subjectFood effecten
dc.subjectFasting protocolen
dc.subjectGastric emptyingen
dc.titleToward the establishment of a standardized pre-clinical porcine model to predict food effects - case studies on Fenofibrate and Paracetamolen
dc.typeArticle (peer-reviewed)en
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