dc.check.date	2019-07-11
dc.check.info	Access to this article is restricted until 12 months after publication by request of the publisher.	en
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.contributor.funder	Science Foundation Ireland	en
dc.contributor.funder	Enterprise Ireland	en
dc.date.accessioned	2018-08-14T08:21:43Z
dc.date.available	2018-08-14T08:21:43Z
dc.date.issued	2018-07-11
dc.date.updated	2018-08-14T08:14:44Z
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.description.status	Peer reviewed	en
dc.description.version	Accepted Version	en
dc.format.mimetype	application/pdf	en
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.doi	10.1016/j.ejpb.2018.07.011
dc.identifier.endpage	24	en
dc.identifier.issn	1873-3441
dc.identifier.issn	0939-6411
dc.identifier.journaltitle	European Journal of Pharmaceutics and Biopharmaceutics	en
dc.identifier.startpage	8	en
dc.identifier.uri	https://hdl.handle.net/10468/6601
dc.identifier.volume	131	en
dc.language.iso	en	en
dc.publisher	Elsevier B.V.	en
dc.relation.project	info:eu-repo/grantAgreement/SFI/SFI Research Centres/12/RC/2275/IE/Synthesis and Solid State Pharmaceutical Centre (SSPC)/	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

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

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