Litalien, Catherine;
Bérubé, Sophie;
Tuleu, Catherine;
Gilpin, Andrea;
Landry, Émilie Kate;
Valentin, Marie;
Strickley, Robert;
(2022)
From paediatric formulations development to access: Advances made and remaining challenges.
British Journal of Clinical Pharmacology
, 88
(10)
pp. 4349-4383.
10.1111/bcp.15293.
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Abstract
Developing suitable paediatric formulations and ensuring access to them by the greatest number of the 2.2 billion children worldwide are equally important to provide optimal pharmacotherapy. This review focuses on the progress made over the last two decades with paediatric oral formulations with respect to evidence for acceptability and dosing flexibility of liquid and solid oral dosage forms (SODFs). It also discusses the clinical needs for, and the access to, paediatric formulations for existing authorised medicines. A significant body of new knowledge now supports the acceptability of solid oral dosage forms (SODFs) in children, resulting in an increasing number of medicines commercialised as multiparticulates, including minitablets that are starting to be brought to market. However, there are gaps with these formulations that deserve more research. Even though efforts have been made to identify medicines in need of age-appropriate formulations, there is no common priority list shared internationally. Such prioritization would help to develop paediatric formulations with the greatest potential for providing a health benefit to children worldwide. In addition, available data highlight that paediatric formulation access is fragmented and unequal, with commercialisation of suitable paediatric formulations too often limited to some countries/regions. We propose actions to better align decisions during the development of paediatric formulations and promote a more globalized approach to facilitate registration pathways between different jurisdictions. Furthermore, discussions about alignment between approval, pricing, and reimbursement processes should also happen, leaving working in siloes behind us. It is time adults start thinking outside the box for children.
| Type: | Article |
|---|---|
| Title: | From paediatric formulations development to access: Advances made and remaining challenges |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1111/bcp.15293 |
| Publisher version: | https://doi.org/10.1111/bcp.15293 |
| 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: | Access, flexible solid oral forms, liquid oral forms, minitablets, multiparticulates, paediatric formulations |
| UCL classification: | 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 > Pharmaceutics UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10144585 |
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