CAT: Creating Acceptable Tablets
Research type
Research Study
Full title
A feasibility study to assess swallowability and acceptability of solid dosage forms in children and young people.
IRAS ID
228063
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 better medicines for children is currently a “hot” topic in the pharmaceutical industry as there are very few age-appropriate and acceptable medicines for this population. \nLiquid medicines have been traditionally considered the most commonly used oral formulation for children, as they are easy to swallow by the patient and doses can be measured at the point of use. However, the taste of paediatric medicines is one of the most important formulation factors which has the potential to influence adherence and compliance to treatment regimens. Research studies have shown that many children do not like the taste of oral liquid medicines. To solve this problem, tablets could be a better option for children. 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.\nWe want to improve medicines for children. This study will gain knowledge on what children think about the possibility of taking tablets as a treatment option instead of oral liquid medicines when they are unwell and if they are able and willing to swallow tablets. We want to understand which size tablets, if any, are suitable for children to take. There are three different sized 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.\nThis 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 swallowability and acceptability of different sized tablets is feasible within a paediatric population. With equal importance, estimations of consent/recruitment rates and completeness of administration interventions is pivotal for the development of future formulation studies within the paediatric population. \n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0410
Date of REC Opinion
13 Jul 2017
REC opinion
Favourable Opinion