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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-10303492 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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