Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study
Nao Mitsui,
Noriko Hida,
Taro Kamiya,
Taigi Yamazaki,
Kazuki Miyazaki,
Kiyomi Saito,
Jumpei Saito,
Akimasa Yamatani,
Yoichi Ishikawa,
Hidefumi Nakamura,
Akihiro Nakamura,
Tsutomu Harada
Affiliations
Nao Mitsui
Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Noriko Hida
Department of Pharmacology, Clinical Pharmacology School of Medicine, Showa University, 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo 157-8577, Japan
Taro Kamiya
Department of Pediatrics, School of Medicine, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Taigi Yamazaki
Clinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University Karasuyama Hospital, 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo 157-8577, Japan
Kazuki Miyazaki
Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Kiyomi Saito
Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Jumpei Saito
Department of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, Japan
Akimasa Yamatani
Department of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, Japan
Yoichi Ishikawa
Department of Pediatric Medication, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, Japan
Hidefumi Nakamura
Department of Research and Development Supervision, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, Japan
Akihiro Nakamura
Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Tsutomu Harada
Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Minitablets have garnered interest as a new paediatric formulation that is easier to swallow than liquid formulations. In Japan, besides the latter, fine granules are frequently used for children. We examined the swallowability of multiple drug-free minitablets and compared it with that of fine granules and liquid formulations in 40 children of two age groups (n = 20 each, aged 6–11 and 12–23 months). We compared the percentage of children who could swallow minitablets without chewing with that of children who could swallow fine granules or liquid formulations without leftover. The children who visited the paediatric department of Showa University Hospital were enrolled. Their caregivers were allowed to choose the administration method. In total, 37 out of 40 caregivers dispersed the fine granules in water. Significantly more children (80%, 95% CI: 56–94%) aged 6–11 months could swallow the minitablets than those who could swallow all the dispersed fine granules and liquid formulations (22%, 95% CI: 6–47% and 35%, 95% CI: 15–59%, respectively). No significant differences were observed in children aged 12–23 months. Hence, minitablets may be easier to swallow than dispersed fine granules and liquid formulations in children aged 6–11 months.
