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Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children

Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicin...

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Autores principales: Haslund-Krog, Sissel Sundell, Jørgensen, Inger Merete, Dalhoff, Kim, Holst, Helle
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9406412/
https://www.ncbi.nlm.nih.gov/pubmed/36010126
http://dx.doi.org/10.3390/children9081236
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author Haslund-Krog, Sissel Sundell
Jørgensen, Inger Merete
Dalhoff, Kim
Holst, Helle
author_facet Haslund-Krog, Sissel Sundell
Jørgensen, Inger Merete
Dalhoff, Kim
Holst, Helle
author_sort Haslund-Krog, Sissel Sundell
collection PubMed
description Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability is still a challenge. This study was an open-label randomised three-arm cross-over study investigating different formulations of prednisolone (crushed tablets, whole tablets, and oral solution) in paediatric patients with asthma and asthma-like symptoms. Participants were randomised into two different formulations on two consecutive days. For each formulation, the child or caregiver was asked to evaluate acceptability using a modified five-point Wong Baker Face scale. An analysis of variance (ANOVA) model was used to test for significance. For the 41 children, included mean age was 4.7 years (SD ± 3.6), and mean weight was 21 kg (SD ± 10.8). Sixty-one percent were boys. The participants were divided accordingly into three age groups: 6 to 23 months (N = 11), 2 to 5 years (N = 14), and 6–11 years (N = 16). The overall acceptability was low, with only 23 out of 71 scores rating the treatment either 1 or 2 (32%). The ANOVA test showed a significant difference in acceptability score between crushed tablets and whole tablets (p < 0.003). The mean acceptability score for the crushed tablet was the least favourable at 3.9 compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4). This is problematic in long-term treatment and for the youngest children who cannot swallow tablets. The improvement of age-appropriate and acceptable formulations is necessary.
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spelling pubmed-94064122022-08-26 Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children Haslund-Krog, Sissel Sundell Jørgensen, Inger Merete Dalhoff, Kim Holst, Helle Children (Basel) Article Developing acceptable medicines for children is a complicated task. Several factors must be considered, including age, physiology, texture preference, formulation, and legal framework among others. In the development of new paediatric medicines, these factors are assessed. However, for older medicines, e.g., prednisolone, acceptability is still a challenge. This study was an open-label randomised three-arm cross-over study investigating different formulations of prednisolone (crushed tablets, whole tablets, and oral solution) in paediatric patients with asthma and asthma-like symptoms. Participants were randomised into two different formulations on two consecutive days. For each formulation, the child or caregiver was asked to evaluate acceptability using a modified five-point Wong Baker Face scale. An analysis of variance (ANOVA) model was used to test for significance. For the 41 children, included mean age was 4.7 years (SD ± 3.6), and mean weight was 21 kg (SD ± 10.8). Sixty-one percent were boys. The participants were divided accordingly into three age groups: 6 to 23 months (N = 11), 2 to 5 years (N = 14), and 6–11 years (N = 16). The overall acceptability was low, with only 23 out of 71 scores rating the treatment either 1 or 2 (32%). The ANOVA test showed a significant difference in acceptability score between crushed tablets and whole tablets (p < 0.003). The mean acceptability score for the crushed tablet was the least favourable at 3.9 compared to oral solution (3.1), oro-dispersible tablet (2.8), and whole tablets (2.4). This is problematic in long-term treatment and for the youngest children who cannot swallow tablets. The improvement of age-appropriate and acceptable formulations is necessary. MDPI 2022-08-16 /pmc/articles/PMC9406412/ /pubmed/36010126 http://dx.doi.org/10.3390/children9081236 Text en © 2022 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
Haslund-Krog, Sissel Sundell
Jørgensen, Inger Merete
Dalhoff, Kim
Holst, Helle
Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title_full Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title_fullStr Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title_full_unstemmed Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title_short Acceptability of Prednisolone in an Open-Label Randomised Cross-Over Study—Focus on Formulation in Children
title_sort acceptability of prednisolone in an open-label randomised cross-over study—focus on formulation in children
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9406412/
https://www.ncbi.nlm.nih.gov/pubmed/36010126
http://dx.doi.org/10.3390/children9081236
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