Abstract
Patient acceptability is an important consideration in the design of medicines for children. The aim of this study was to investigate acceptability of multiparticulates in healthy children and adults. A randomised, single-blind acceptability testing was performed involving 71 children (4–12 years) and 61 adults (18–37 years). Each participant received three 500 mg samples of microcrystalline cellulose pellets administered on a medicine spoon with water at 5–10 minutes intervals. Acceptability was measured based on voluntary intake of the samples, facial expressions, ratings on hedonic scales and reported willingness to take multiparticulates everyday as a medicine. Multiparticulates were voluntarily swallowed by 92% of children and 100% of adults. However, palatability issues were identified, with emphasis on textural aspects. Grittiness perception received negative ratings on hedonic scales by 60% of children and 51% of adults. Researcher observations revealed that 72% of children and 42% of adults displayed negative facial expressions towards the samples. Children reported their willingness to take multiparticulates as a medicine in 30% of the cases, compared to 74% in adults. This study demonstrates that multiparticulates may be a suitable formulation platform for children and adults, although palatability concerns have been highlighted. Additional work is required to define acceptability criteria and to standardise methodologies.
Highlights
Patient acceptability has been defined by the European Medicines Agency (EMA) as the ability and willingness of a patient and their caregiver to use and administer a medicine as intended[1]
Consideration must be given to the selection of the most suitable formulation for the target population group[1]; fundamental knowledge about age-appropriateness of different dosage forms is still limited and fragmented[2]
Pharmaceutical regulatory bodies such as the EMA recommend to carry out palatability and acceptability testing of paediatric medicines in the targeted age group[1]
Summary
Patient acceptability has been defined by the European Medicines Agency (EMA) as the ability and willingness of a patient and their caregiver to use and administer a medicine as intended[1]. Oral solid formulations are gaining support from regulatory authorities, based on their better stability profile, lower number of (potentially hazardous) excipients and suitability for taste-masking and controlled-release via film coating[1,3] This paradigm shift in the selection of the most appropriate dosage form has been reinforced by recent studies supporting acceptability of solid medicines in children, including the youngest populations of preschool children and neonates[4,5,6,7,8,9]. More trials are required to investigate the impact of formulation factors (i.e. the effect of size of multiparticulates, presence or absence of film coating or amount of dosage units per dose) on patient acceptability Pharmaceutical regulatory bodies such as the EMA recommend to carry out palatability and acceptability testing of paediatric medicines in the targeted age group[1]. The proportion of participants able to (safely and completely) swallow a pre-defined dose has been recently used as a simple measure of patient acceptability in various studies[4,5,6,9]
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