TY - JOUR
T1 - Assessment of swallowability and palatability of oral dosage forms in children
T2 - Report from an M-CERSI pediatric formulation workshop
AU - Ternik, Robert
AU - Liu, Fang
AU - Bartlett, Jeremy A
AU - Khong, Yuet Mei
AU - Thiam Tan, David Cheng
AU - Dixit, Trupti
AU - Wang, Siri
AU - Galella, Elizabeth A
AU - Gao, Zhihui
AU - Klein, Sandra
N1 - © 2017 Elsevier B.V. This manuscript is made available under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND 4.0). For further details please see: https://creativecommons.org/licenses/by-nc-nd/4.0/
PY - 2018/2/5
Y1 - 2018/2/5
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1016/j.ijpharm.2017.08.088
DO - 10.1016/j.ijpharm.2017.08.088
M3 - Article
C2 - 28844897
SN - 0378-5173
VL - 536
SP - 570
EP - 581
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 2
ER -