Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study
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 gran...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-01-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/14/1/198 |
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| author | Nao Mitsui Noriko Hida Taro Kamiya Taigi Yamazaki Kazuki Miyazaki Kiyomi Saito Jumpei Saito Akimasa Yamatani Yoichi Ishikawa Hidefumi Nakamura Akihiro Nakamura Tsutomu Harada |
| author_facet | Nao Mitsui Noriko Hida Taro Kamiya Taigi Yamazaki Kazuki Miyazaki Kiyomi Saito Jumpei Saito Akimasa Yamatani Yoichi Ishikawa Hidefumi Nakamura Akihiro Nakamura Tsutomu Harada |
| author_sort | Nao Mitsui |
| collection | DOAJ |
| description | 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 (<i>n</i> = 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. |
| first_indexed | 2024-03-10T00:42:17Z |
| format | Article |
| id | doaj.art-b42869dae65044df96de5545da0100a7 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T00:42:17Z |
| publishDate | 2022-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-b42869dae65044df96de5545da0100a72023-11-23T15:05:29ZengMDPI AGPharmaceutics1999-49232022-01-0114119810.3390/pharmaceutics14010198Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover StudyNao Mitsui0Noriko Hida1Taro Kamiya2Taigi Yamazaki3Kazuki Miyazaki4Kiyomi Saito5Jumpei Saito6Akimasa Yamatani7Yoichi Ishikawa8Hidefumi Nakamura9Akihiro Nakamura10Tsutomu Harada11Division of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanDepartment of Pharmacology, Clinical Pharmacology School of Medicine, Showa University, 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo 157-8577, JapanDepartment of Pediatrics, School of Medicine, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanClinical Research Institute for Clinical Pharmacology and Therapeutics, Showa University Karasuyama Hospital, 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo 157-8577, JapanDivision of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanDivision of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanDepartment of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, JapanDepartment of Pharmacy, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, JapanDepartment of Pediatric Medication, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, JapanDepartment of Research and Development Supervision, National Center for Child Health and Development, 2-10-1 Okura, Setagaya-ku, Tokyo 157-8435, JapanDivision of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanDivision of Pharmaceutics, Department of Pharmacology, Toxicology and Therapeutics, School of Pharmacy, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, JapanMinitablets 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 (<i>n</i> = 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.https://www.mdpi.com/1999-4923/14/1/198fine granulesliquid formulationsinfants |
| spellingShingle | Nao Mitsui Noriko Hida Taro Kamiya Taigi Yamazaki Kazuki Miyazaki Kiyomi Saito Jumpei Saito Akimasa Yamatani Yoichi Ishikawa Hidefumi Nakamura Akihiro Nakamura Tsutomu Harada Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study Pharmaceutics fine granules liquid formulations infants |
| title | Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study |
| title_full | Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study |
| title_fullStr | Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study |
| title_full_unstemmed | Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study |
| title_short | Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study |
| title_sort | swallowability of minitablets among children aged 6 23 months an exploratory randomized crossover study |
| topic | fine granules liquid formulations infants |
| url | https://www.mdpi.com/1999-4923/14/1/198 |
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