Best Practice Recommendations Regarding the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Abstract

The palatability of oral drugs influences patient adherence to prescribed regimens, especially for children. Various factors influence palatability, including smell, taste, texture, and dose volume. Evaluation of these factors plays an important role in pediatric drug development and is a target for regulatory scrutiny. The Global Alliance for Pediatric Therapeutics, a public-private consortium under the guidance of the Institute for Pediatric Innovation, convened the Alliance Palatability Working Group to discuss the issues related to the assessment of palatability in the development of pediatric oral dosage forms. An extensive scientific literature search was conducted, in addition to a multicompany industry survey and a series of workshops with the Alliance Palatability Working Group. Based on the results, 3 best practice recommendations emerged regarding the assessment of palatability for oral dosage forms in pediatric drug development. These best practice recommendations offer researchers guidance for the preclinical and clinical assessment of palatability of oral dosage forms and serve to operationalize the assessment process within the overall drug development program.

Keywords: dosage form; formulation; organoleptic properties; patient adherence; sensory panel; taste-masking agents.