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Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study

Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month–6 years (stratified: 4–6 y...

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Autores principales: Münch, Juliane, Sessler, Isabelle, Bosse, Hans Martin, Wargenau, Manfred, Dreesen, Janine D., Loforese, Giulio, Webb, Nicholas J. A., Sivasubramanian, Rama, Reidemeister, Sibylle, Lustenberger, Philipp, Klingmann, Viviane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303492/
https://www.ncbi.nlm.nih.gov/pubmed/37376177
http://dx.doi.org/10.3390/pharmaceutics15061729
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author Münch, Juliane
Sessler, Isabelle
Bosse, Hans Martin
Wargenau, Manfred
Dreesen, Janine D.
Loforese, Giulio
Webb, Nicholas J. A.
Sivasubramanian, Rama
Reidemeister, Sibylle
Lustenberger, Philipp
Klingmann, Viviane
author_facet Münch, Juliane
Sessler, Isabelle
Bosse, Hans Martin
Wargenau, Manfred
Dreesen, Janine D.
Loforese, Giulio
Webb, Nicholas J. A.
Sivasubramanian, Rama
Reidemeister, Sibylle
Lustenberger, Philipp
Klingmann, Viviane
author_sort Münch, Juliane
collection PubMed
description Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month–6 years (stratified: 4–6 years, 2–<4 years, 1–<2 years, 6–<12 months, and 1–<6 months), and their preference for swallowing either a high quantity of 2.0 mm or a low quantity of 2.5 mm diameter mini-tablets. The primary endpoint was acceptability derived from swallowability. The secondary endpoints were investigator-observed palatability, acceptability as a composite endpoint derived from both swallowability and palatability, and safety. Of 320 children randomized, 319 completed the study. Across all tablet sizes, quantities and age groups, acceptability rates based on swallowability were high (at least 87%). Palatability was rated as “pleasant/neutral” in 96.6% of children. The acceptability rates as per the composite endpoint were at least 77% and 86% for the 2.0 mm and 2.5 mm film-coated mini-tablets, respectively. No adverse events or deaths were reported. Recruitment in the 1–<6-months group was stopped early due to coughing—evaluated as “choked on” in three children. Both 2.0 mm and 2.5 mm film-coated mini-tablets are suitable formulations for young children.
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spelling pubmed-103034922023-06-29 Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study Münch, Juliane Sessler, Isabelle Bosse, Hans Martin Wargenau, Manfred Dreesen, Janine D. Loforese, Giulio Webb, Nicholas J. A. Sivasubramanian, Rama Reidemeister, Sibylle Lustenberger, Philipp Klingmann, Viviane Pharmaceutics Article Mini-tablets are advantageous over liquid formulations in overcoming challenges related to stability, taste, and dosage. This open-label, single-dose, cross-over study investigated the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month–6 years (stratified: 4–6 years, 2–<4 years, 1–<2 years, 6–<12 months, and 1–<6 months), and their preference for swallowing either a high quantity of 2.0 mm or a low quantity of 2.5 mm diameter mini-tablets. The primary endpoint was acceptability derived from swallowability. The secondary endpoints were investigator-observed palatability, acceptability as a composite endpoint derived from both swallowability and palatability, and safety. Of 320 children randomized, 319 completed the study. Across all tablet sizes, quantities and age groups, acceptability rates based on swallowability were high (at least 87%). Palatability was rated as “pleasant/neutral” in 96.6% of children. The acceptability rates as per the composite endpoint were at least 77% and 86% for the 2.0 mm and 2.5 mm film-coated mini-tablets, respectively. No adverse events or deaths were reported. Recruitment in the 1–<6-months group was stopped early due to coughing—evaluated as “choked on” in three children. Both 2.0 mm and 2.5 mm film-coated mini-tablets are suitable formulations for young children. MDPI 2023-06-14 /pmc/articles/PMC10303492/ /pubmed/37376177 http://dx.doi.org/10.3390/pharmaceutics15061729 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Münch, Juliane
Sessler, Isabelle
Bosse, Hans Martin
Wargenau, Manfred
Dreesen, Janine D.
Loforese, Giulio
Webb, Nicholas J. A.
Sivasubramanian, Rama
Reidemeister, Sibylle
Lustenberger, Philipp
Klingmann, Viviane
Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title_full Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title_fullStr Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title_full_unstemmed Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title_short Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young Children: Results from an Open-Label, Single-Dose, Cross-Over Study
title_sort evaluating the acceptability, swallowability, and palatability of film-coated mini-tablet formulation in young children: results from an open-label, single-dose, cross-over study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10303492/
https://www.ncbi.nlm.nih.gov/pubmed/37376177
http://dx.doi.org/10.3390/pharmaceutics15061729
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