Abstract
Raw materials in pediatric formulations such as excipients, food ingredients, and active pharmaceutical ingredients (APIs) have received significant attention from regulatory agencies worldwide in recent times due to safety concerns. Not all excipients and food ingredients are “inert” and have been shown to interfere with the growth and development process in pediatric population. Though raw materials incorporated in drug products require extensive safety testing prior to their inclusion in the formulations, there are very few excipients that have undergone randomized clinical trial (RCT) in the pediatric subpopulation. Therefore, this chapter will provide an overview of selected excipients and APIs that are routinely included in pediatric products with reference to their chemical structure, chemical reactivity, and allowable daily intake for pediatric use.
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Abbreviations
- API:
-
Active pharmaceutical ingredient
- ADME:
-
Absorption, distribution, metabolism, and excretion
- FDA:
-
US Food and Drug Administration
- FDC:
-
Food Drugs and Chemicals
- GRAS:
-
Generally recognized as safe
- RCT:
-
Randomized clinical trials
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Chatterjee, P., Alvi, M.M. (2014). Excipients and Active Pharmaceutical Ingredients. In: Bar-Shalom, D., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 11. Springer, New York, NY. https://doi.org/10.1007/978-1-4899-8011-3_24
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DOI: https://doi.org/10.1007/978-1-4899-8011-3_24
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