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Creating Acceptable Tablets 3D (CAT 3D): A Feasibility Study to Evaluate the Acceptability of 3D Printed Tablets in Children and Young People

Research output: Contribution to journalArticlepeer-review

Louise Bracken, Rober Habashy, Emma McDonough, Fiona Wilson, Joanne Shakeshaft, Udeme Ohia, Tamar Garcia-Sorribes, Abdullah Isreb, Mohamed A. Alhnan, Matthew Peak

Original languageEnglish
Article number516
JournalPharmaceutics
Volume14
Issue number3
Early online date25 Feb 2022
DOIs
Accepted/In press18 Feb 2022
E-pub ahead of print25 Feb 2022
Published31 Mar 2022

Bibliographical note

Funding Information: Funding: The project was partially funded by Alder Hey Children’s NHS Foundation Trust. No additional external funding was required for this work. Publisher Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

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Abstract

3D printing (3DP) has been proposed as a novel approach for personalising dosage forms for children and young people (CYP). Owing to its low cost and the lack of need for finishing steps, fused deposing modelling (FDM) 3DP has been heavily researched in solid dosage forms (SDFs) manufacturing. However, the swallowability and overall acceptability of 3D printed dosage forms are yet to be established. This work is the first to evaluate the acceptability of different sized 3D printed placebo SDFs in CYP (aged 4–12 years). All participants had previously participated in a feasibility study (CAT study) that assessed the swallowability and acceptability of different sized GMP manufactured placebo conventional film-coated tablets, and therefore only attempted to swallow one 3D printed tablet. The participants assessed the swallowability, acceptability, mouthfeel, volume of water consumed, and taste of the sample using a 5-point hedonic facial scale on a partic-ipant questionnaire. A total of 30 participants were recruited, 87% of whom successfully swallowed the 3D printed tablet that they attempted to take. Attributes of the 3D printed tablets were scored as acceptable by the following percentage of participants—swallowability (80%), mouthfeel/texture (87%), the volume of water consumed (80%), taste (93%), and overall acceptability (83%). Overall, 77% of children reported they would be happy to take the tablet every day if it was a medicine. Participants were also asked which tablets felt better in the mouth—the film-coated tablets or the 3D printed tablets, and the most popular response (43%) was that both were acceptable. This study shows that FDM-based 3D printed SDFs may be a suitable dosage form for children aged 4–12 years. The results from this feasibility study will be used to inform a larger, definitive study looking at the acceptability of 3D printed tablets in children.

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