title: Formulation factors affecting acceptability of oral medicines in children.
abstract: Acceptability of medicines in children and caregivers affects safety and effectiveness of medicinal treatments. The pharmaceutical industry is required to demonstrate acceptability of new paediatric formulations in target age groups as an integrated part of the development of these products (Kozarewicz, 2014). Two questions arise when trying to tackle this task: "which dosage form to choose for each target age group?" and "how to formulate it once the dosage form is decided?". Inevitably, both the regulator and the developer turn to scientific evidence for answers. Research has emerged in recent years to demonstrate age-appropriateness and patient acceptability of different dosage forms; however, such information is still fragmented and far from satisfactory to define efficient formulation development strategies for a diverse patient subset (Ranmal and Tuleu, 2013). This paper highlights how formulation factors affect the acceptability of different oral medicines in children (Table 1), and it is based on a more extensive review article by Liu et al. (Liu et al., 2014). Gaps in knowledge are highlighted in order to stimulate further research. In some areas, findings from studies conducted in adult populations may provide useful guidance for paediatric development and this is also discussed.
authors.affiliation: Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK. Electronic address: f.liu3@herts.ac.uk.
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
authors.forename: Sejal
authors.initials: S
authors.lastname: Ranmal
authors.affiliation: Pharmacy, Pharmacology and Therapeutics, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
authors.forename: Hannah K
authors.initials: HK
authors.lastname: Batchelor
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
authors.forename: Mine
authors.initials: M
authors.lastname: Orlu-Gul
authors.affiliation: GlaxoSmithKline, New Frontiers Science Park, Third Avenue, Harlow, Essex CM19 5AW, UK.
authors.forename: Terry B
authors.initials: TB
authors.lastname: Ernest
authors.affiliation: Piramal Healthcare UK Ltd, Whalton Road, Morpeth, Northumberland, NE61 3YA, UK.
authors.forename: Iwan W
authors.initials: IW
authors.lastname: Thomas
authors.affiliation: Pharmaceutical Development, AstraZeneca, Silk Road, Macclesfield, Cheshire SK10 2NA, UK.
authors.forename: Talia
authors.initials: T
authors.lastname: Flanagan
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Kendall
authors.affiliation: Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Tuleu
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002648:Child; D004304:Dosage Forms; D006801:Humans
chemical_list: D004304:Dosage Forms