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 participant 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.
Highlights
The administration of medicines to children and young people (CYP) poses a challenge to many parents and healthcare professionals
As producing bi-convex tablets from both sides is difficult to achieve in fused deposing modelling (FDM) 3D printing (3DP) without additional steps, the design was modified to include a flat base
In FDM 3D printing, a layer thickness of 200 μm is often considered as an optimal value between resolution and 3D printing time
Summary
The administration of medicines to children and young people (CYP) poses a challenge to many parents and healthcare professionals. Medication adherence rates in CYP range from 11% to 93% [1]. Developing medicines that are acceptable to CYP have the potential to influence adherence to therapeutic regimens and improve treatment outcomes [2]. Acceptability has previously been defined as “an overall ability of the patient and caregiver. Oral liquids were generally regarded to be the most appropriate dosage form for children. Challenges such as taste masking, portability, stability, and the inclusion of excipients are all factors to be considered in the selection of an appropriate dosage form for children [4,5]
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