Year: 2026
Type: article
Abstract: PURPOSE: Pediatric global regulatory initiatives have come into place to address gaps in evidence-based medicine for children. Objective of this study was to assess age-appropriateness of oral pediatric formulations authorized through the U.S. Food and Drug Administration's Pediatric Rule, Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. METHODS: Formulation age-appropriateness was assessed using an adapted version of the World Health Organization pediatric quality product profile assessment tool. Evaluations encompassed four product attributes across pediatric subgroups: dose and dose flexibility, patient acceptability, excipient safety and administration considerations. Each attribute was scored on a three-point scale: 1 indicating high risk, 2 moderate risk, and 3 low risk. RESULTS: 214 oral formulations were evaluated. Age-appropriateness remains a concern; with less than one third of authorized oral formulations for neonates meeting criteria for age-appropriateness, in comparison to 66% for older pediatric populations. Tablets and capsules constitute 58% of formulations indicated for pediatrics, despite tablet sizes often being unsuitable for younger children. Liquid formulations for neonates present a significant oversight, as they frequently contain excipients of potential concern. As children age, swallowability of the dosage form appears to be deprioritized, with only 37% of unswallowable large size tablets for school-aged children, available in alternative dosage forms such as granules, or solids for dispersions. CONCLUSIONS: Significant formulation gaps persist in pediatric medicine, with acceptability and excipient safety presenting highest risk. The potential of non-conventional solid dosage forms remains underutilized, underscoring the need for regulatory frameworks to support development of pediatric medicines.
Source: Pharmaceutical Research
Authors: Hannah R. Weiler, Lauren M. Le, Hala M. Fadda
Institution: Butler University
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,690
OpenAlex ID: W7136283682