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Acceptability of placebo multiparticulate formulations in children and adults
Felipe L Lopez1, Punam Mistry2, Hannah K Batchelor2
1School of Pharmacy, University College London, London, United Kingdom.
Insights
Multiparticulate medicines are generally accepted by children and adults, but taste and texture issues like grittiness need improvement for better patient acceptability.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Medicine
- Drug Delivery Systems
Background:
- Patient acceptability is crucial for pediatric medicine design.
- Multiparticulate formulations offer potential advantages in drug delivery.
Purpose of the Study:
- To assess the acceptability of microcrystalline cellulose pellets in children and adults.
- To identify palatability and textural challenges associated with multiparticulates.
Main Methods:
- A randomized, single-blind acceptability study involving 71 children and 61 adults.
- Evaluation based on voluntary intake, facial expressions, hedonic ratings, and willingness to take daily.
- Administration of 500 mg microcrystalline cellulose pellets on a medicine spoon with water.
Main Results:
- 92% of children and 100% of adults voluntarily swallowed the pellets.
- Significant negative ratings for grittiness (60% children, 51% adults).
- Willingness to take daily was lower in children (30%) compared to adults (74%).
Conclusions:
- Multiparticulates show promise as a formulation platform for both pediatric and adult populations.
- Palatability, particularly texture, requires further optimization for improved patient acceptability.
- Standardized methodologies and defined acceptability criteria are needed for future research.
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.
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