Parenteral protein formulations: an overview of approved products within the European Union

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dc.contributor.author Gervasi, Valeria
dc.contributor.author Dall Agnol, R.
dc.contributor.author Cullen, S.
dc.contributor.author McCoy, T.
dc.contributor.author Vucen, Sonja
dc.contributor.author Crean, Abina M.
dc.date.accessioned 2018-08-14T08:21:43Z
dc.date.available 2018-08-14T08:21:43Z
dc.date.issued 2018-07-11
dc.identifier.citation Gervasi, V., Dall Agnol, R., Cullen, S., McCoy, T., Vucen, S. and Crean, A. (2018) 'Parenteral protein formulations: an overview of approved products within the European Union', European Journal of Pharmaceutics and Biopharmaceutics, 131, pp. 8-24. doi:10.1016/j.ejpb.2018.07.011 en
dc.identifier.volume 131 en
dc.identifier.startpage 8 en
dc.identifier.endpage 24 en
dc.identifier.issn 1873-3441
dc.identifier.issn 0939-6411
dc.identifier.uri http://hdl.handle.net/10468/6601
dc.identifier.doi 10.1016/j.ejpb.2018.07.011
dc.description.abstract The study presented is a comprehensive overview of commercial parenteral protein formulations, approved by the European Medicines Agency (EMA), 1995-2018. The objective of this overview was to analyse current trends in the design of commercial parenteral protein products and thereby support formulation scientists in the design of new formulations. The main data source was the publicly available European Public Assessment Reports (EPARs) published by the EMA for each authorised product. An analysis of the percentage of formulations in a liquid and lyophilised form was conducted. In addition, the number of products containing individual excipients, classified into functional categories is provided. Finally, the overview includes comprehensive details of product compositions obtained from EMA, US Food and Drug Administration (FDA) and product Marketing Authorisation Holder. Data analysis highlighted trends in the number of products approved, and the higher percentage of liquid parenteral protein formulations (66%) compared to lyophilised formulations (34%). This overview identifies the most commonly incorporated excipients employed as buffering agents, stabilisers/bulking agents, surfactants, preservatives and tonicifiers, including their concentration ranges of use in both liquid and lyophilised formulation approaches. Finally, antibody-based formulations were a particular focus of this overview. The relationship between parenteral routes of administration and antibody concentrations in approved products was also investigated. en
dc.description.sponsorship Enterprise Ireland (Grant Number IP/2015 0358) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Elsevier B.V. en
dc.rights © 2018, Elsevier B.V. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license. en
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ en
dc.subject Excipients en
dc.subject Proteins en
dc.subject Antibodies en
dc.subject Formulation en
dc.subject Lyophilisation en
dc.subject High concentration en
dc.subject European Medicines Agency en
dc.title Parenteral protein formulations: an overview of approved products within the European Union en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Abina Crean, School Of Pharmacy, University College Cork, Cork, Ireland. +353-21-490-3000 Email: a.crean@ucc.ie en
dc.internal.availability Full text available en
dc.check.info Access to this article is restricted until 12 months after publication by request of the publisher. en
dc.check.date 2019-07-11
dc.date.updated 2018-08-14T08:14:44Z
dc.description.version Accepted Version en
dc.internal.rssid 447234254
dc.internal.pmid 30006246
dc.contributor.funder Science Foundation Ireland en
dc.contributor.funder Enterprise Ireland en
dc.description.status Peer reviewed en
dc.identifier.journaltitle European Journal of Pharmaceutics and Biopharmaceutics en
dc.internal.copyrightchecked Yes en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress a.crean@ucc.ie en
dc.relation.project info:eu-repo/grantAgreement/SFI/SFI Research Centres/12/RC/2275/IE/Synthesis and Solid State Pharmaceutical Centre (SSPC)/ en


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© 2018, Elsevier B.V. All rights reserved.  This manuscript version is made available under the CC-BY-NC-ND 4.0 license. Except where otherwise noted, this item's license is described as © 2018, Elsevier B.V. All rights reserved. This manuscript version is made available under the CC-BY-NC-ND 4.0 license.
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