Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop

Robert Ternik, Fang Liu, Jeremy A Bartlett, Yuet Mei Khong, David Cheng Thiam Tan, Trupti Dixit, Siri Wang, Elizabeth A Galella, Zhihui Gao, Sandra Klein

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24 Citations (Scopus)
51 Downloads (Pure)

Abstract

The acceptability of pediatric pharmaceutical products to patients and their caregivers can have a profound impact on the resulting therapeutic outcome. However, existing methodology and approaches used for acceptability assessments for pediatric products is fragmented, making robust and consistent product evaluations difficult. A pediatric formulation development workshop took place in Washington, DC in June 2016 through the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI). A session at the workshop was dedicated to acceptability assessments and focused on two major elements that affect the overall acceptability of oral medicines, namely swallowability and palatability. The session started with presentations to provide an overview of literature, background and current state on swallowability and palatability assessments. Five parallel breakout discussions followed the presentations on each element, focusing on three overarching themes, risk-based approaches, methodology and product factors. This article reports the key outcomes of the workshop related to swallowability and palatability assessments.
Original languageEnglish
Pages (from-to)570-581
Number of pages12
JournalInternational Journal of Pharmaceutics
Volume536
Issue number2
Early online date24 Aug 2017
DOIs
Publication statusPublished - 5 Feb 2018

Keywords

  • Journal Article

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