CAT 3D : Creating Acceptable Tablets 3D
Research type
Research Study
Full title
A feasibility study to evaluate the mouthfeel of 3D printed tablets in children.
IRAS ID
233808
Contact name
Matthew Peak
Contact email
Sponsor organisation
Alder Hey Children's Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Developing acceptable and age-appropriate medicines for children is currently an area of great interest. With the taste of medicines being a most important formulation factor to influence adherence and compliance within the paediatric population, tablet formulations may be an attractive alternative option for this population. More recently, oral solid formulations are gaining support from regulatory authorities; based on their better stability profile, lower number of (potentially toxic) ingredients and suitability for taste-masking via a film coating.
Currently tablets don’t allow for flexible dosing, therefore they are often manipulated to obtain the correct dose; this outcome of this could be imprecise dosing and also the possibility of adverse drug reactions. 3D printing of tablets offers tailored medicines to meet the individual’s needs.
This study will evaluate children’s perceptions on the mouthfeel (texture), ability to swallow and overall acceptability of 3D printed tablets. This study will also gain knowledge on what children think about the possibility of taking tablets as a treatment option instead of the more commonly used oral liquid medicines when they are unwell and if they are able and willing to swallow tablets.
We also want to understand which size tablets, if any, are suitable for children to take. There are three different sized 3D printed placebo tablets (these samples do not contain any medicine) and we would like children to tell us which sample, if any, is the easiest to swallow and what they think the texture of a 3D tablet feels like in their mouth.
This feasibility study will collate data on key variables which will inform the design of a larger, definitive study. The primary focus is to identify whether a study investigating the mouthfeel and swallowability of different sized 3D printed placebo tablets is feasible within a paediatric population.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0019
Date of REC Opinion
6 Feb 2018
REC opinion
Favourable Opinion