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Swallowability of Minitablets among Children Aged 6-23 Months: An Exploratory, Randomized Crossover Study
Nao Mitsui1, Noriko Hida2,3, Taro Kamiya4
1Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan.
Pharmaceutics
|January 21, 2022
Summary
Minitablets show promise as a more swallowable pediatric formulation. For infants aged 6-11 months, minitablets were significantly easier to swallow than fine granules or liquids.
Area of Science:
- Pediatric Pharmacology
- Drug Delivery Systems
- Swallowing Physiology
Background:
- Minitablets are emerging as a preferred pediatric oral dosage form over liquids.
- Fine granules are also commonly used for pediatric administration in Japan.
- Swallowability is a critical factor for successful pediatric medication adherence.
Purpose of the Study:
- To evaluate and compare the swallowability of minitablets versus fine granules and liquid formulations in pediatric patients.
- To assess differences in swallowability across two distinct pediatric age groups.
Main Methods:
- A study involving 40 children across two age groups (6-11 months and 12-23 months) was conducted.
- Children were administered drug-free minitablets, fine granules (often dispersed in water), and liquid formulations.
- The primary outcome measured was the percentage of children able to swallow each formulation without chewing or residue.
Main Results:
- In children aged 6-11 months, 80% could swallow minitablets, compared to 22% for dispersed fine granules and 35% for liquids.
- No significant differences in swallowability were found between the formulations in children aged 12-23 months.
- Caregiver preference led to 37 out of 40 participants dispersing fine granules in water.
Conclusions:
- Minitablets may offer superior swallowability compared to dispersed fine granules and liquid formulations in infants aged 6-11 months.
- The findings suggest minitablets could improve medication administration for younger children.
- Further research may explore the long-term benefits and acceptance of minitablets in pediatric populations.
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