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Best practices for selection of excipients for paediatrics - Workshop reflection

Salunke, S; Clapham, D; Agrawal, A; Hughes, K; Nunn, T; (2021) Best practices for selection of excipients for paediatrics - Workshop reflection. European Journal of Pharmaceutics and Biopharmaceutics , 160 pp. 77-81. 10.1016/j.ejpb.2020.12.021.

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Abstract

The development of age appropriate formulations for the paediatric population has become one of the key areas of focus for the pharmaceutical industry - with a subsequent influence on excipient use. Selection of excipients with appropriate safety and tolerability is a major hurdle in paediatric formulation development. Various factors influence selection of excipients, including target age group, route of administration and dosage form. Evaluation of these factors and a clear rationale and justification is expected by the regulators when it comes to selecting excipients for paediatric formulation. Scientists are encouraged to apply the principle of benefit to risk balance to assess the suitability of excipients to the specific paediatric population for whom the formulation is intended. In order to understand how scientists approach the task of establishing the risk to benefit analysis, a workshop was organised by the European Paediatric Formulation Initiative (EuPFI) to reflect on the current scenario and the different practices employed by formulation scientists in the selection of excipients for paediatric formulations. Aspects assessed by regulators were also canvassed. Finally, the participants were asked to comment on how selecting excipients for use in paediatric formulations may differ from the considerations applied in selecting excipients for formulations for other age groups. Based on the workshop discussion, some recommendations and questions to consider emerged regarding the selection of excipients in paediatric drug development. These best practice recommendations provided a good starting point for a more systematic strategy for selecting excipients for paediatric formulation development.

Type: Article
Title: Best practices for selection of excipients for paediatrics - Workshop reflection
Location: Netherlands
DOI: 10.1016/j.ejpb.2020.12.021
Publisher version: http://dx.doi.org/10.1016/j.ejpb.2020.12.021
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Choice, Drug development, EuPFI, Excipients, Formulation, Medicines, Paediatric, Pharmaceutical, Risk assessment, Workshop
UCL classification: UCL
UCL > Provost and Vice Provost Offices
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/10122525
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