A Systematic Literature Review on the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Background: Palatability and swallowability of oral dosage forms are important considerations in the development of medications for pediatric populations. As a result of recent legislation, the number of pharmaceutical products being developed with formulations for children is increasing. However, there are limited recommendations and published literature regarding appropriate palatability and swallowability assessment scales in pediatric patients. Objective: This systematic literature review aimed to identify and evaluate tools currently utilized to assess palatability and swallowability in clinical trials for pediatric oral dosage forms and identify any potential relationships between palatability and treatment adherence. Literature databases were searched for clinical trials that evaluated palatability of oral dosage forms targeted for pediatric patients. The searches were limited to papers in the English language from January 2008 to March 2013. Results: A total of 137 citations were identified, with 27 articles included in the final full-text analysis. Conclusions: Various limitations to this systematic review exist, primarily focused on the unavailability of published, early phase development data related to palatability. However, based on results of this review, palatability is often assessed in clinical trials of pediatric dosage forms through the utilization of 2 unvalidated, yet widely accepted, visual scales. There is no standard statistical methodology for analyzing the results of these scales or the cross-comparison of results across studies. Limited evidence regarding a correlation between palatability and treatment adherence in pediatric patients was identified.