Characterization of gastrointestinal transit and luminal conditions in pigs using a telemetric motility capsule

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dc.contributor.authorHenze, Laura J.
dc.contributor.authorKoehl, Niklas J.
dc.contributor.authorBennett-Lenane, Harriet
dc.contributor.authorHolm, René
dc.contributor.authorGrimm, Michael
dc.contributor.authorSchneider, Felix
dc.contributor.authorWeitschies, Werner
dc.contributor.authorKoziolek, Mirko
dc.contributor.authorGriffin, Brendan T.
dc.contributor.funderHorizon 2020en
dc.contributor.funderH2020 Marie Skłodowska-Curie Actionsen
dc.contributor.funderEuropean Cooperation in Science and Technologyen
dc.date.accessioned2021-06-03T12:12:34Z
dc.date.available2021-06-03T12:12:34Z
dc.date.issued2020-10-27
dc.date.updated2021-06-03T11:51:24Z
dc.description.abstractWithin preclinical research, the pig has become an important model in regulatory toxicology and pharmacokinetics, to assess oral dosage forms and to compare different formulation strategies. In addition, there are emerging application of the pig model to asses clinical dosing conditions in the fasted and fed state. In this study, the gastrointestinal transit conditions in male landrace pigs were studied with a telemetric motility capsule under fasted and postprandial conditions. The whole gut transit time (WGTT) was determined by administering a SmartPill® capsule to four landrace pigs, under both fasted and fed state conditions in a cross-over study design. Overall, this study found that small intestinal transit in landrace pigs ranged from 2.3 – 4.0 h, and was broadly similar to reported human estimates and was not affected by the intake conditions. Gastric emptying was highly variable and prolonged in landrace pigs ranging from 20 – 233 h and up to 264 h in one specific case. Under dynamic conditions pigs have a low gastric pH comparable to humans, however a high variability under fasted conditions could be observed. The comparison of the data from this study with a recent similar study in beagle dogs revealed major differences between gastric maximum pressures observed in landrace pigs and dogs. In the porcine stomach maximum pressures of up to 402 mbar were observed, which are comparable to reported human data. Intestinal maximum pressures in landrace pigs were in the same range as in humans. Overall, the study provides new insights of gastrointestinal conditions in landrace pigs, which can lead to more accurate interpretation of in vivo results obtained of pharmacokinetic studies in preclinical models. While small intestinal transit conditions, GI pH and pressures were similar to humans, the prolonged gastric emptying observed in pigs need to be considered in assessing the suitability of the pig model for assessing in vivo performance of large non-disintegrated oral drug products..en
dc.description.sponsorshipEuropean Cooperation in Science and Technology (COST Action UNGAP (CA16205))en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid105627en
dc.identifier.citationHenze, L. J., Koehl, N. J., Bennett-Lenane, H., Holm, R., Grimm, M., Schneider, F., Weitschies, W., Koziolek, M. and Griffin, B. T. (2021) 'Characterization of gastrointestinal transit and luminal conditions in pigs using a telemetric motility capsule', European Journal of Pharmaceutical Sciences, 156, 105627 (11 pp). doi: 10.1016/j.ejps.2020.105627en
dc.identifier.doi10.1016/j.ejps.2020.105627en
dc.identifier.endpage11en
dc.identifier.issn0928-0987
dc.identifier.journaltitleEuropean Journal of Pharmaceutical Sciencesen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/11443
dc.identifier.volume156en
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.urihttps://www.sciencedirect.com/science/article/pii/S0928098720304152
dc.rights© 2020 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectGastrointestinal transiten
dc.subjectIntestine motilityen
dc.subjectIntestine transit timeen
dc.subjectLandrace pig; maleen
dc.subjectProduct developmenten
dc.subjectStomach emptyingen
dc.subjectStomach pHen
dc.subjectTelemetryen
dc.subjectTemperatureen
dc.titleCharacterization of gastrointestinal transit and luminal conditions in pigs using a telemetric motility capsuleen
dc.typeArticle (peer-reviewed)en
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