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Assessment of swallowability and palatability of oral dosage forms in children : Report from an M-CERSI pediatric formulation workshop. / Ternik, Robert; Liu, Fang; Bartlett, Jeremy A; Khong, Yuet Mei; Thiam Tan, David Cheng; Dixit, Trupti; Wang, Siri; Galella, Elizabeth A; Gao, Zhihui; Klein, Sandra.

In: International Journal of Pharmaceutics, Vol. 536, No. 2, 05.02.2018, p. 570-581.

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Ternik, Robert ; Liu, Fang ; Bartlett, Jeremy A ; Khong, Yuet Mei ; Thiam Tan, David Cheng ; Dixit, Trupti ; Wang, Siri ; Galella, Elizabeth A ; Gao, Zhihui ; Klein, Sandra. / Assessment of swallowability and palatability of oral dosage forms in children : Report from an M-CERSI pediatric formulation workshop. In: International Journal of Pharmaceutics. 2018 ; Vol. 536, No. 2. pp. 570-581.

Bibtex

@article{2d854fd869614eefb3cb3a3ab93c1933,
title = "Assessment of swallowability and palatability of oral dosage forms in children: Report from an M-CERSI pediatric formulation workshop",
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.",
keywords = "Journal Article",
author = "Robert Ternik and Fang Liu and Bartlett, {Jeremy A} and Khong, {Yuet Mei} and {Thiam Tan}, {David Cheng} and Trupti Dixit and Siri Wang and Galella, {Elizabeth A} and Zhihui Gao and Sandra Klein",
note = "{\textcopyright} 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/ ",
year = "2018",
month = feb,
day = "5",
doi = "10.1016/j.ijpharm.2017.08.088",
language = "English",
volume = "536",
pages = "570--581",
journal = "International Journal of Pharmaceutics",
issn = "0378-5173",
publisher = "Elsevier",
number = "2",

}

RIS

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

VL - 536

SP - 570

EP - 581

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

IS - 2

ER -