Industry Survey on Current Practices in the Assessment of Palatability and Swallowability in the Development of Pediatric Oral Dosage Forms

Abstract

An industry-based survey was conducted by the Global Alliance for Pediatric Therapeutics in February 2013 to determine and evaluate the current industry practices in the assessment of palatability and swallowability during the development of pediatric oral solid dosage forms, including the design and statistical analysis of such studies. In addition, the survey was designed to identify areas where regulatory guidance is most needed. The survey was distributed to 6 research-based pharmaceutical companies and to members of the American Academy of Pediatrics’ Provisional Section on Advances in Therapeutics and Technology. In general, while all responding companies have experience developing pediatric medicines, there was no consistent approach among respondents to the assessment of organoleptic properties of solid dosage forms, including excipients. In the direct assessment of palatability in pediatric patients in clinical trials, the survey identified that a variety of methods is used across companies, including visual analogue scales, simple and complex hedonic scales, and simplistic Likert-type scales. No assessment method identified was acknowledged as validated or with any statistical correlates, with many respondents stating that scales used in the pharmaceutical industry are adapted from the significant work conducted in the food service industry. Based on findings from the industry survey, the authors believe that there is an opportunity for consensus of the assessment of palatability and swallowability in the development of pediatric oral solid dosage forms.