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A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool
Justyna Katarzyna Hofmanová1, Joanne Bennett2, Alastair Coupe2
1School of Pharmacy, Institute of Clinical Sciences, University of Birmingham, Birmingham B15 2TT, UK.
Insights
A novel oral syringe effectively dispenses multiparticulate formulations (MPs) for children. This device allows flexible dosing of MPs, improving medication administration for pediatric patients.
Area of Science:
- Pediatric pharmacology
- Drug delivery systems
- Formulation science
Background:
- Multiparticulate formulations (MPs) are increasingly popular pediatric dosage forms due to ease of swallowing.
- Current administration methods for MPs, such as unit doses, limit flexible dosing potential.
- A standardized pediatric device could optimize the administration of MPs.
Purpose of the Study:
- To evaluate a novel oral syringe designed for dispensing and administering multiparticulate formulations (MPs) to children.
- To assess the swallowability and acceptability of different dose volumes administered via the novel oral syringe.
- To determine if a drink of choice improves acceptability compared to water.
Main Methods:
- Forty children aged 4-12 years participated in the study.
- Placebo MPs were administered in 0.5, 1.2, and 2.0 mL doses using the novel oral syringe.
- Doses were given with either spring water or a drink of choice.
- Swallowability and willingness to take the dose daily were recorded.
Main Results:
- Swallowability decreased with increasing dose volume; 87.5% swallowed the smallest dose (0.5 mL).
- Willingness to take the smallest dose daily was 69.4%.
- Acceptability and willingness to take larger doses (1.2 and 2.0 mL) were lower, and a drink of choice did not improve swallowability.
Conclusions:
- The novel oral syringe is a suitable device for flexible dispensing and direct administration of low-volume, neutral-tasting MPs in children aged 4-12.
- The device shows promise for improving pediatric medication administration, particularly for smaller doses.
- Further research may explore optimizing administration for larger MP volumes.
Abstract:
The popularity of multiparticulate formulations (MPs) as a paediatric dosage form continues to increase. MPs comprise of multiple small units that are easy-to-swallow. Currently, MPs are commonly manufactured into unit doses that are either swallowed whole or opened prior to administration. While this is an acceptable approach, dosing is envisioned to be optimised with a "standard" paediatric device which can better harness the flexible dosing potential of MPs. We evaluated a novel oral syringe (SympfinyTM, HS Design, Morristown, NJ, USA) that is being developed as a tool to dispense and administer MPs to children. Forty children, 4-12 years old, received 0.5, 1.2, and 2.0 mL doses of placebo MPs using the oral syringe with spring water or a drink of choice to complete sample intake. Acceptability was recorded as those able to completely swallow the dose and participants also rated dose acceptability on a 5-point scale. The ability to completely swallow the dose decreased as dose volume increased; the smallest dose was completely swallowed by 87.5% (35/40) children, and 69.4% (27/39) of children confirmed their willingness to take the sample as a daily medicine. Larger doses, 1.2 and 2.0 mL, gave values of 55% and 57.5% for the doses completely swallowed and 58.8% and 51.72% for willingness to take the sample as a daily medicine, respectively. Use of a drink of choice showed no increase in swallowability as compared with water. The novel oral syringe being developed is an appropriate device for dispensing doses flexibly and administering neutral tasting MPs directly to the mouth in the lower dose range without the need for a co-administration vehicle in children aged 4-12 years.
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