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

Abstract

Introduction

The last several decades have seen the global emergence of legislation promoting pediatric drug development.1,2 In the U.S. both incentives and requirements have been advanced to encourage pharmaceutical manufacturers to seek labeling for drugs in children; however, nowhere in this legislation is the explicit requirement that a suitable pediatric formulation accompany regulatory approval.3–5 Regulatory authorities outside of the U.S. follow suit with Japan’s Pharmaceuticals and Medical Devices Agency taking the position that pediatric formulation development is a corporate decision, and the European Medicines Agency (EMA), Health Canada, the Australia’s Therapeutic Goods Administration, and others who follow their lead permitting exceptions to pediatric formulation development.6–8

Complicating implementation of these regulatory recommendations is 1) the lack of a clear definition on what constitutes an age-appropriate pediatric formulation and 2) the absence of standardized methods for evaluating age-appropriateness. Some thought leaders center their definition on the capabilities of the child (a formulation for which a child of a specified age/age group would have the natural ability to use, without the product having to be altered from its original or intended presentation prior to administration).9 Others emphasize the product label as the focus (an authorised medicine used within the terms of its marketing authorisation which can be taken/used by the child without any issues on administration).10 Recognizing that no formulation is ideal for all children of a given age group, U.S. Food and Drug Administration (FDA) and EMA guidance relies largely on high-level definitions (a medicine, whose pharmaceutical design makes it suitable for use in the target age group(s)), with suggested formulation types by age group.11

Without pediatric formulations, there is limited assurance that medicines can be safely and accurately administered to children. Given the lack of an enforceable mandate to market pediatric formulations, this research was undertaken to examine the nature of commercial products available at the time of pediatric labeling by the FDA. Since retrospective analyses are inapt for making determinations about the suitability and acceptability of formulations for a given age group (i.e. age-appropriateness), this paper restricts the characterization of products to those that may require extemporaneous manipulation prior to administration to children (termed “adult formulations”) and those that, in theory, should be simpler to administer to children with greater ease and/or accuracy (termed “pediatric-friendly”).12

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JPPT | Exploratory Evaluation of Public Databases, Suitability of Oral Formulations Available to Children at the Time of Pediatric Labeling, Susan M. Abdel-Rahman, PharmD; Debbie A. Avant, BS; and Gilbert J. Burckart, PharmD, Editorial Type: RESEARCH | Online Publication Date: 19 Jun 2026, https://jppt.kglmeridian.com/view/journals/jppt/aop/article-10.5863-JPPT-25-00141/article-10.5863-JPPT-25-00141.xml

Read also our introduction article on Orally Disintegrating Tablets (ODTs) here: