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Children 2015, 2(2), 191-197; doi:10.3390/children2020191

Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals?

F. Hoffmann-La Roche Ltd., Roche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, Basel CH-4070, Switzerland
Academic Editors: Johannes N. van den Anker and Klaus Rose
Received: 3 March 2015 / Revised: 2 April 2015 / Accepted: 27 April 2015 / Published: 15 May 2015
(This article belongs to the Special Issue Development of Medicines for Paediatric and Rare Diseases)
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Abstract

The development of drug products for pediatric use often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms. Excipients established for adult use are not always appropriate for use in children because they can affect children differently than adults. Therefore, a comprehensive safety assessment of the excipients in a pediatric formulation is essential before use, referring to existing safety data from adult human and animals as well as safety data from pediatric use and juvenile toxicity studies, when available. The overall risk assessment needs to consider the safety risk from the excipients and the extent to which the risk from the disease as such will be ameliorated by the drug formulation. Non-clinical safety studies in juvenile animals are used to assess for specific toxicities or sensitivities of excipients and for establishing safe exposures in pediatric age groups. As for any active ingredient, non-clinical safety studies in juvenile animals should only be performed for excipients if important for clinical risk assessment and labelling. Pharmaceutical companies should be critical of excessive demands for juvenile animal testing, particularly of excipients when critically needed for significant therapeutic benefit. View Full-Text
Keywords: pediatric drug development; pediatric formulations; safety; juvenile animal studies pediatric drug development; pediatric formulations; safety; juvenile animal studies
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Schmitt, G. Safety of Excipients in Pediatric Formulations—A Call for Toxicity Studies in Juvenile Animals? Children 2015, 2, 191-197.

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