Saito, J; Agrawal, A; Patravale, V; Pandya, A; Orubu, S; Salunke, S; Zhao, M; ... Croker, A; + view all Saito, J; Agrawal, A; Patravale, V; Pandya, A; Orubu, S; Salunke, S; Zhao, M; Petit-Turcotte, C; Landry, H; Mao, H; Croker, A; - view fewer (2021) Excipients for Paediatric Population-Shared Issues Need Unified Solution. Pharma Times , 53 (12) pp. 38-42.

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Abstract

A major hurdle in pediatric formulation development is the lack of safety and toxic data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients including preterm neonates are not established yet due to the lack of evidence-based data. This article covers the current state, challenges, ongoing efforts and future perspectives on excipients for pediatric formulation in each country and region. As a common issue, lack of information and insufficient regulation process were found. Efforts such as raising issues on excipient exposure, building the database for excipients and improving excipients regulation process are in progress, however, there is a lack of evidence-based information on safety of excipients for the pediatric population. Some guidelines regarding excipient usage in pediatric formulations in some region or country are available but a harmonized guideline with more clear safety limits and quantitative information on excipients of concern in the pediatric population is needed. Internationally harmonized excipients’ regulatory process may contribute to ensuring safe medicinal treatment for the pediatric population.

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