Abstract
Orodispersible films (ODFs) possess potential to facilitate oral drug delivery to children; however, documentation of their acceptability in this age group is lacking. This study is the first to explore the initial perceptions, acceptability and ease of use of ODFs for infants and preschool children, and their caregivers through observed administration of the type of dosage form. Placebo ODFs were administered to children stratified into aged 6 to 12 months, 1 year, 2 years, 3 years, 4 years and 5 years old and into those with an acute illness or long-term stable condition in hospital setting. Acceptability of the dosage form and end-user views were assessed by (a) direct observation of administration, (b) questionnaires to caregivers and nurses, and (c) age-adapted questionnaires for children aged 3 years and over. The majority of children (78%) aged 3 years and over gave the ODF a positive rating both on verbal and non-verbal scales. Despite little prior experience, 78% of caregivers expressed positive opinion about ODFs before administration. After the ODFs were taken, 79% of infant caregivers and 86% caregivers of preschool children positively rated their child’s acceptance of the ODF. The intraclass correlation coefficient value was 0.92 showing good agreement between ratings of caregivers and nurses. ODFs showed a high degree of acceptability among young children and their caregivers. If drug loading permits, pharmaceutical companies should consider developing pediatric medicines in this format. The methodology described here is useful in assessing the acceptability of active ODF preparations and other dosage forms to children.
Highlights
The European Union Paediatric Regulation by the European Medicines Agency (EMA) is about to celebrate its 10th anniversary
Orodispersible films (ODFs) are postage stamp sized strips of thin polymeric films formulated to quickly disintegrate in the mouth when placed onto the tongue (Hoffmann et al, 2011)
110 children were recruited in the study (59% male), of which 66 were infants and 44 were preschool children.The majority of participants (91%) were reported to be eating normal family food while 6% had reached soft chew solids and the remaining 3% were reported to be eating purees
Summary
The European Union Paediatric Regulation by the European Medicines Agency (EMA) is about to celebrate its 10th anniversary. Fo end-user requirements and acceptability of formulationstype of dosage form, which limits choice in the development of paediatric medicines. ODFs have ee been presented as a promising formulation platformtype of dosage form for non-standard patient populations who experience difficulties swallowing oral medicines, such as children and older adults (Slavkova and Breitkreutz, 2015). An increasing number of studies have focused on their pharmaceutical development, including formulation optimisation, characterisation, assessment of ev mechanical properties and efficient taste masking of the drug to be loaded into the film (Hoffmann et al, 2011; Visser et al, 2015; Borges et al, 2015; Preis et al, 2013; Brniak et al, 2015). There are currently no published empirical studies demonstrating the acceptability of ODFs among children and their caregivers in acute or non-acute situations
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