Development and evaluation of a biorelevant medium simulating porcine gastrointestinal fluids

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dc.contributor.author Henze, Laura J.
dc.contributor.author Koehl, Niklas J.
dc.contributor.author Jansen, Regina
dc.contributor.author Holm, René
dc.contributor.author Vertzoni, Maria
dc.contributor.author Whitfield, Phil D.
dc.contributor.author Griffin, Brendan T.
dc.date.accessioned 2020-10-16T10:56:00Z
dc.date.available 2020-10-16T10:56:00Z
dc.date.issued 2020-06-21
dc.identifier.citation Henze, L. J., Koehl, N. J., Jansen, R., Holm, R., Vertzoni, M.,Whitfield, P. D. and Griffin, B. T. (2020) 'Development and evaluation of a biorelevant medium simulating porcine gastrointestinal fluids', European Journal of Pharmaceutics and Biopharmaceutics, 154, pp. 116-126. doi: 10.1016/j.ejpb.2020.06.009 en
dc.identifier.volume 154 en
dc.identifier.startpage 116 en
dc.identifier.endpage 126 en
dc.identifier.issn 1873-3441
dc.identifier.issn 0939-6411
dc.identifier.uri http://hdl.handle.net/10468/10660
dc.identifier.doi 10.1016/j.ejpb.2020.06.009 en
dc.description.abstract Simulated human intestinal media, have proved to be a useful biopharmaceutics tool as a dissolution media for predicting in vivo dissolution and pharmacokinetic profile in humans. During drug product development preclinical animal models are also required to assess drug product performance, and there is a need to develop species specific intestinal media to similarly predict in vivo pharmacokinetic profiles in each preclinical model. Pigs, are increasingly being used in preclinical drug development, however to date there is a lack of quantitative information about the composition of porcine gastrointestinal (GI) fluids. As a result, a porcine biorelevant medium has not yet been developed, which is essential to improve interpretation and forecast of preclinical results using biorelevant in vitro dissolution studies. GI fluid samples, were collected from landrace pigs, and characterized. Fasted State Simulated Intestinal Fluid of pigs (FaSSIFp) was developed based on the physiological composition of the GI fluids in terms of pH, buffer capacity, osmolality, surface tension, as well as the bile salt, phospholipid and free fatty acid content. This study demonstrated that FaSSIFp was superior at predicting the solubility of the six model drugs in porcine intestinal fluids (PIF). A markedly high correlation (r2 0.98) was observed between the solubility obtained in PIF and FaSSIFp, whereas poor correlation (r2 0.12) was found for the solubility of the model drugs between human FaSSIF and PIF. This confirms that species specific biorelevant intestinal media are crucial to provide more accurate predictions of pharmacokinetic studies in preclinical models. Additionally, the availability of a species specific intestinal medium offers the potential to improve in vitro-in silico approaches to predict in vivo absorption and to reduce the overall number of animals needed in oral drug product development testing. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier B. V. en
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.uri http://creativecommons.org/licenses/by/4.0 en
dc.subject Biorelevant media en
dc.subject Pigs en
dc.subject Gastrointestinal fluid en
dc.subject Dissolution test en
dc.subject Bile salts en
dc.subject Phospholipids en
dc.subject FaSSIF en
dc.subject Pre-clinical model en
dc.subject Animal model en
dc.subject FaSSIFp en
dc.title Development and evaluation of a biorelevant medium simulating porcine gastrointestinal fluids en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Brendan Griffin, Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: brendan.griffin@ucc.ie en
dc.internal.availability Full text available en
dc.date.updated 2020-10-16T10:47:01Z
dc.description.version Accepted Version en
dc.internal.rssid 522595147
dc.internal.pmid 32580049
dc.contributor.funder Horizon 2020 en
dc.description.status Peer reviewed en
dc.identifier.journaltitle European Journal of Pharmaceutics and Biopharmaceutics en
dc.internal.copyrightchecked Yes
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress brendan.griffin@ucc.ie en
dc.internal.IRISemailaddress laura.henze@ucc.ie 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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© 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/). Except where otherwise noted, this item's license is described as © 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/).
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