Acceptability of placebo multiparticulate formulations in children and adults

Felipe L. Lopez, Hannah Batchelor, Punam Mistry, Joanne Bennett, Alastair Coupe, Terry B. Ernest, Mine Orlu-Gul, Catherine Tuleu

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)
128 Downloads (Pure)

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.
Original languageEnglish
Article number9210
Number of pages10
JournalScientific Reports
Volume8
Issue number1
Early online date15 Jun 2018
DOIs
Publication statusPublished - 1 Dec 2018

Keywords

  • Drug delivery
  • Drug development
  • Paediatric research

ASJC Scopus subject areas

  • General

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