Food for thought: formulating away the food effect - a PEARRL review

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dc.contributor.authorO'Shea, Joseph P.
dc.contributor.authorHolm, René
dc.contributor.authorO'Driscoll, Caitríona M.
dc.contributor.authorGriffin, Brendan T.
dc.contributor.funderHorizon 2020en
dc.date.accessioned2018-11-13T14:44:02Z
dc.date.available2018-11-13T14:44:02Z
dc.date.issued2018-06-28
dc.date.updated2018-11-13T14:34:20Z
dc.description.abstractObjectives: Co‐ingestion of oral dosage forms with meals can cause substantial changes in bioavailability relative to the fasted state. Food‐mediated effects on bioavailability can have significant consequences in drug development, regulatory and clinical settings. To date, the primary focus of research has focused on the ability to mechanistically understand the causes and predict the occurrence of these effects. Key findings: The current review describes the mechanisms underpinning the occurrence of food effects, sheds new insights on the relative frequency for newly licensed medicines and describes the various methods by which they can be overcome. Analysis of oral medicines licensed by either the EMA or FDA since 2010 revealed that over 40% display significant food effects. Due to altered bioavailability, these medicines are often required to be dosed, rather restrictively, in either the fed or the fasted state, which can hinder clinical usefulness. Summary: There are clinical and commercial advantages to predicting the presence of food effects early in the drug development process, in order to mitigate this risk of variable food effect bioavailability. Formulation approaches aimed at reducing variable food‐dependent bioavailability, through the use of bio‐enabling formulations, are an essential tool in addressing this challenge and the latest state of the art in this field are summarised here.en
dc.description.statusPeer revieweden
dc.description.versionAccepted Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationO'Shea, J. P., Holm, R., O'Driscoll, C. M. and Griffin, B. T. 'Food for thought: formulating away the food effect – a PEARRL review', Journal of Pharmacy and Pharmacology, 71(4), pp.510-535 doi: 10.1111/jphp.12957en
dc.identifier.doi10.1111/jphp.12957
dc.identifier.endpage535en
dc.identifier.issn0022-3573
dc.identifier.issued4en
dc.identifier.journaltitleJournal of Pharmacy and Pharmacologyen
dc.identifier.startpage510en
dc.identifier.urihttps://hdl.handle.net/10468/7108
dc.identifier.volume71en
dc.language.isoenen
dc.publisherWileyen
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://onlinelibrary.wiley.com/doi/abs/10.1111/jphp.12957
dc.rights© 2018 Royal Pharmaceutical Society. This is the peer reviewed version of the following article: O'Shea, J. P., Holm, R., O'Driscoll, C. M. and Griffin, B. T. (2018), Food for thought: formulating away the food effect – a PEARRL review. J Pharm Pharmacol., which has been published in final form at https://doi.org/10.1111/jphp.12957. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.en
dc.subjectBio-enabling formulationsen
dc.subjectFood effecten
dc.subjectFood-drug interactionsen
dc.subjectFormulation screeningen
dc.subjectGastrointestinal physiologyen
dc.titleFood for thought: formulating away the food effect - a PEARRL reviewen
dc.typeArticle (peer-reviewed)en
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