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.author Henze, Laura J.
dc.contributor.author Koehl, Niklas J.
dc.contributor.author O'Shea, Joseph P.
dc.contributor.author Holm, René
dc.contributor.author Vertzoni, Maria
dc.contributor.author Griffin, Brendan T.
dc.date.accessioned 2019-05-29T11:13:46Z
dc.date.available 2019-05-29T11:13:46Z
dc.date.issued 2019-05-28
dc.identifier.citation Henze, 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.2019.100017 en
dc.identifier.startpage 1 en
dc.identifier.endpage 9 en
dc.identifier.issn 2590-1567
dc.identifier.uri http://hdl.handle.net/10468/7997
dc.identifier.doi 10.1016/j.ijpx.2019.100017 en
dc.description.abstract A 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.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier en
dc.relation.uri http://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 license en
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Landrace pigs en
dc.subject Minipigs en
dc.subject Food effect en
dc.subject Fasting protocol en
dc.subject Gastric emptying en
dc.title Toward the establishment of a standardized pre-clinical porcine model to predict food effects - case studies on Fenofibrate and Paracetamol en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Laura Henze, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: laura.henze@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2019-05-29T11:07:44Z
dc.description.version Accepted Version en
dc.internal.rssid 487025693
dc.contributor.funder Horizon 2020 en
dc.description.status Peer reviewed en
dc.identifier.journaltitle International Journal Of Pharmaceutics: X en
dc.internal.copyrightchecked Yes
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress laura.henze@ucc.ie en
dc.internal.IRISemailaddress brendan.griffin@ucc.ie en
dc.identifier.articleid 100017 en
dc.relation.project info: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/PEARRL en


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© 2019 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license Except where otherwise noted, this item's license is described as © 2019 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license
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