Agrawal, Anjali;
Salunke, Smita;
Rumondor, Alfred;
Thompson, Karen;
Caivano, Grazia;
Walsh, Jennifer;
Enright, Brian;
... Kuehl, Peter; + view all
(2024)
Paediatric excipient risk assessment (PERA) tool and application for selecting appropriate excipients for paediatric dosage forms - Part 2.
European Journal of Pharmaceutics and Biopharmaceutics
, 203
, Article 114447. 10.1016/j.ejpb.2024.114447.
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Abstract
It is necessary to use a scientifically sound process for excipient risk evaluation, selection, and management in order to develop paediatric medicinal products that are both safe and effective. The “Paediatric Excipient Risk Assessment (PERA)” framework, which proposes a comprehensive approach by considering all relevant factors related to patient, dosage form, and excipient attributes, was developed and published as part 1 of this paper series, to enable the rational selection of excipients for paediatric medicinal products. This article is Part 2 of the series and presents the PERA tool that allows easy adoption of the PERA framework. Using a straightforward heat map scoring approach (Red, Yellow, and Green category) for risk evaluation, the PERA tool can be used to compare and choose excipients. The PERA tool will help users identify potential gaps in excipients information that will help with risk-based mitigation planning. Several case studies covering frequently used and novel excipients for oral, as well as the choice of excipient for parenteral products for neonatal administration, serve to illustrate the PERA tool's usefulness.
| Type: | Article |
|---|---|
| Title: | Paediatric excipient risk assessment (PERA) tool and application for selecting appropriate excipients for paediatric dosage forms - Part 2 |
| Location: | Netherlands |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.ejpb.2024.114447 |
| Publisher version: | http://dx.doi.org/10.1016/j.ejpb.2024.114447 |
| Language: | English |
| Additional information: | © 2024 The Authors. Published by Elsevier B.V. under a Creative Commons license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| Keywords: | Paediatric, Age-appropriate, Formulation, Excipients, Inactive ingredients, Risk assessment |
| 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.ucl.ac.uk/id/eprint/10198079 |
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