Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

Abstract

A lack of evidence to guide the design of age-appropriate and acceptable dosage forms has been a longstanding knowledge gap in paediatric formulation development. The Children's Acceptability of Oral Formulations (CALF) study captured end-user perceptions and practices with a focus on solid oral dosage forms, namely tablets, capsules, chewables, orodispersibles, multiparticulates (administered with food) and mini-tablets (administered directly into the mouth). A rigorous development and testing phase produced age-adapted questionnaires as measurement tools with strong evidence of validity and reliability. Overall, 590 school children and adolescents, and 428 adult caregivers were surveyed across hospitals and various community settings. Attitudes towards dosage forms primarily differed based on age and prior use. Positive attitudes to tablets and capsules increased with age until around 14 years. Preference was seen for chewable and orodispersible preparations across ages, while multiparticulates were seemingly less favourable. Overall, 59.6% of school children reported willingness to take 10mm diameter tablets, although only 32.1% of caregivers perceived this size to be suitable. While not to be taken as prescriptive guidance, the results of this study provide some evidence towards rational dosage form design, as well as methodological approaches to help design tools for further evaluation of acceptability within paediatric studies.

Register‐based study showed that the age when children were prescribed antibiotic tablets and capsules instead of liquids increased from 2004 to 2016

“…Girls and female prescribers had a slightly higher association with the prescriptions of liquids. This was in accordance with previous studies that showed that women have greater difficulty swallowing solid formulations than men and that boys believe they can swallow larger solids than girls . The literature does not offer any explanation for these gender differences.…”

Manipulation of oral medication for children by parents and nurses occurs frequently and is often not supported by instructions

“…An electronic questionnaire was built using the web‐based LimeSurvey version 2.06 (LimeSurvey GmbH, Hamburg, Germany). The questions were derived from sources regarding the manipulation of medicines for paediatric administration, such as the MODRIC guidelines, and additional research regarding manipulation of medication in children . Questions gave insight into the extent, reasons and methods of manipulation of oral dosage forms for children by parents and caregivers, and included six topics: demographic data, current medication, methods and reasons for manipulation, medication adherence in relation to manipulation, the possible combined administration of oral medicines and the sources of information consulted regarding manipulation.…”

Paediatric Medicines: Formulation Considerations

“…It is well known that the paediatric use of off-label and unlicensed medicines are a reality and that there is a lack of medicines well studied for children. Although there are already some studies focusing on the perceptions of children [26][27][28], it is still important to improve our knowledge in this area. It is fundamental to develop research in order to understand attitudes and preferences of children and their caregivers with the aim of developing dosage forms and formulations which are children-friendly.…”