Ruiz, F;
Nunn, A;
Gill, A;
Clapham, D;
Fotaki, N;
Salunke, S;
Cram, A;
(2023)
A review of paediatric injectable drug delivery to inform the study of product acceptability – An introduction.
European Journal of Pharmaceutics and Biopharmaceutics
, 188
pp. 265-270.
10.1016/j.ejpb.2023.04.010.
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Abstract
Aim: The EMA defines acceptability as “the overall ability and willingness of the patient to use, and their caregiver to administer, the medicine as intended” [1]. This paper seeks to outline issues of acceptability in relation to injectable therapy, namely intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration routes, and to lay a foundation to identify a minimum set of data that would satisfy Regulatory Authorities when discussing the acceptability of an injectable product. In addition, it will alert drug product developers to other factors that might contribute to good practice, alternative administration strategies and overall adherence to achieve successful treatment. Whilst the term ‘parenteral’ means “outside the intestine” [2,3] and so potentially covers a range of administration routes including intranasal and percutaneous administration, this review focuses on IV, IM and SC administration by injection. The use of indwelling canulae or catheters to reduce venepuncture and facilitate prolonged treatment is common and may impact acceptability [4]. This may be influenced by information provided by the manufacturer but is not always in their direct control. Other injectable products suitable for routes such as intradermal, intra-articular, intraosseous and intrathecal, share the requirement to be acceptable but are not specifically covered in this paper [2,5].
| Type: | Article |
|---|---|
| Title: | A review of paediatric injectable drug delivery to inform the study of product acceptability – An introduction |
| Location: | Netherlands |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.ejpb.2023.04.010 |
| Publisher version: | https://doi.org/10.1016/j.ejpb.2023.04.010 |
| Language: | English |
| Additional information: | This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third-party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ |
| Keywords: | Acceptability, Injectable, Intramuscular, Intravenous, Paediatric, Parenteral, Subcutaneous |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10172012 |
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