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Acceptability of Multiparticulate Dosing Using Sympfiny® Delivery System with Children (Age 1-12).
Kate Abeln1, Kate Cox1, Laura Haggerty1
1HS Design, Morristown, NJ 07960, USA.
Pharmaceutics
|November 26, 2022
Summary
Multiparticulate drug formulations administered via the Sympfiny system were found acceptable by children aged 5-12. Parents also found the delivery system acceptable for their children, though younger children (1-4 years) had some difficulty with administration.
Area of Science:
- Pediatric pharmacology
- Drug delivery systems
- Formulation science
Background:
- Chemotherapy drugs like PURIXAN (mercaptopurine) and Methotrexate may benefit from reformulation.
- Multiparticulate drug formulations offer advantages such as being flavorless, requiring no liquid reconstitution, and not needing refrigeration.
Purpose of the Study:
- To investigate the acceptability and usability of a multiparticulate formulation delivered via the Sympfiny system in children aged 1-12 years.
- To mimic PURIXAN dosing guidelines using a specific dose strategy.
Main Methods:
- A two-week study involving 120 parent-child pairs.
- Participants administered a placebo dose daily using the Sympfiny system.
- In-person sessions were conducted for observation and data collection, supplemented by daily participant surveys.
Main Results:
- Children aged 5-12 years found the multiparticulate formulation acceptable.
- Younger children (ages 1-4 years) showed lower acceptance, with 15-20% spitting out the placebo.
- Approximately 95% of parents found the Sympfiny system acceptable for medication delivery to their child.
Conclusions:
- Multiparticulate formulations delivered via the Sympfiny system are acceptable for children aged 5-12.
- The Sympfiny system is highly acceptable to parents for pediatric medication delivery.
- Further optimization may be needed for administration in younger children (1-4 years).
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