- Author(s):
- Organization(s):
Faegre Drinker Consulting MOD3 Pharma Nanopharm Ltd
Excipients (also called “inactive ingredients”) play a critical role in formulation performance. They are generally chosen based on their physico-chemical properties, functionality, compatibility with the formulation and device, dose, taste, fragrance (or lack thereof), color and/or ease of administration, as well as the availability of a “safety record.” This review provides a collation of the publicly available information on excipients used in approved pediatric nasal products, compiled from multiple sources.
The United States Food and Drug Administration (FDA) Inactive Ingredient Database (IID) provides valuable information on excipient amounts and maximum daily exposures, although most data are geared toward adult formulations. As the review shows, the list of excipients with specified potencies in pediatric nasal products is rather short, which underscores the necessity for additional research and thorough review of product labels and safety studies to fill existing data gaps. Ensuring the safety and efficacy of excipients in pediatric formulations requires continued data collection and research efforts to address these challenges effectively.
October 2025, Volume 19(5): pages 25-35