Suitability of Oral Formulations Available to Children at the Time of Pediatric Labeling.

Abstract

Background: The pediatric drug development landscape has experienced major shifts, largely in response to legislative and regulatory initiatives. However, associated laws and guidance documents fail to mandate the manufacture of pediatric formulations for commercial marketing post-regulatory approval. This study explores the nature of commercial products available at the time of pediatric labeling.

Methods: All orally administered drugs for which labeling changes were made from 1998-2024 were evaluated. Characteristics of each drug's commercially marketed formulation(s) at the time of labeling were identified using product labeling (Drugs@FDA), Drugs.com, and DailyMed.

Results: During the timeframe reviewed, there were 611 unique labeling changes representing 425 unique drugs available as 567 commercially marketed formulations. Of these drugs, 188 were marketed with pediatric-friendly (PF) formulations. The remainder were available only as solid oral dosage forms. For 329 pediatric labeling changes (53.8%), the only commercially marketed formulation was a solid oral dosage form, in many cases at sizes exceeding reasonable thresholds for the age group. For the remaining 282 labeling changes, a PF formulation was available alone or as a companion to the adult formulation. Among the PF formulations, 62% were suited to direct administration (liquid, orodispersible tablet, chewable/paste, transmucosal) while the remainder required manipulation (i.e. powder/granule, sprinkle/pellet, dispersible tablet). Three-fourths of the PF formulations incorporated flavorings and aromas though 13% failed to report the use of sweeteners.

Conclusions: Less than complete access to PF formulations requires attention if we are to maximize the provision of suitable pharmacotherapy for pediatric patients.