title: 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.
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, UK.
authors.forename: Sejal R
authors.initials: SR
authors.lastname: Ranmal
authors.affiliation: Drug Product Design (DPD), Pfizer Ltd., Discovery Park, Ramsgate Road, Sandwich, CT13 9ND, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Cram
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, 29-39 Brunswick Square, London, WC1N 1AX, UK. Electronic address: c.tuleu@ucl.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002214:Capsules / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical / Q000706:statistics & numerical data*; D002648:Child; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D057240:Patient Preference / Q000523:psychology / Q000706:statistics & numerical data*; D010372:Pediatrics / Q000706:statistics & numerical data*; D013607:Tablets / Q000008:administration & dosage*
chemical_list: D002214:Capsules; D004304:Dosage Forms; D013607:Tablets
keywords: Age-appropriate; Medicine; Paediatric; Patient acceptability; Preferences; Solid oral dosage forms