Abstract
The paucity of evidence-based data on formulation characteristics preferred by the children is known to limit the design of tailored paediatric dosage forms. The European Paediatric Translational Research Infrastructure (EPTRI) commissioned a study to evaluate children’s dosage forms perceived preferences in some European countries and explore the feasibility of using the young persons advisory groups (YPAGs) to involve children in formulation research. An online, age-adapted survey was developed and translated into six languages. The survey link was disseminated across seven European countries: Albania, Italy, the Netherlands, and Dutch-speaking part of Belgium, Romania, Spain, and the United Kingdom. Respondents’ (n = 1172) perceived preferences for oral dosage forms primarily differed based on age, health status, and experience. Conventional dosage forms, i.e., liquid (35%), tablets (19%), and capsules (14%), were the most selected. Liquid was widely selected by children less than 12 years and by those healthy and taking medicines rarely. Monolithic solid forms were mostly chosen by adolescents and by children with a chronic disease taking medicines frequently. There was a clear lack of familiarity with more novel dosage forms (e.g., orodispersible films and granules). Noteworthy, granules were not appreciated, particularly by adolescents (52.8%). To rationalise the creation of paediatric formulations, it is important to involve children as active stakeholders and to apply tools assessing children’s perspectives on medicines to inform acceptable dosage form development from the start.
Highlights
Nowadays, increasing efforts and resources are dedicated to paediatric medicine development to guarantee the authorisation and access to tailored and high-quality medicines for children
One of the barriers slowing the development of age-appropriate paediatric medicines is the lack of knowledge about what dosage forms are considered to be acceptable to the paediatric population [1]
When dividing children according to their experience in terms of medicines use, few changes were observed in the selection of attributes between children who took one or more medicines on a daily basis and those who took medicines rarely
Summary
Nowadays, increasing efforts and resources are dedicated to paediatric medicine development to guarantee the authorisation and access to tailored and high-quality medicines for children. Acceptability is defined as “the overall ability and willingness of the patient to use and its caregiver to administer the medicine as intended” [2,3,4]. This requirement is paramount to guarantee optimal treatment adherence and the efficacy and safety of a therapy [3,4]. Pharmaceutical companies in Europe and the United States are obliged to describe and justify in their paediatric development plans (PIP and PSP) the choice of their formulations for all target populations and to document and report the acceptability of them [1,5]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
