Can preschool-aged children swallow several minitablets at a time? Results from a clinical pilot study.
Minitablets are a novel, multi-compartment solid drug formulation, particularly intended for children between 1 and 6 years of age. Available literature shows that even infants are capable of swallowing a single minitablet. In this study, we have explored the level of acceptance of minitablets administered in units of 5 or 10. A group of thirty two 2-year-old children (2-years) and twenty eight 3-year-old children (3-years) have been enrolled in the study. Each child was asked to swallow placebo minitablets (2mm or 3mm) suspended in a fruity jelly on a spoon. The swallowing of minitablets (with or without chewing) was registered for 75% of 2-year-olds and for 93% of 3-year-olds. Moreover, most of the children (57% of all participants) were fully capable of swallowing all units without chewing (2-years: 50%; 3-years: 64%). However, no statistically significant differences in the swallowing ability were observed in gender and age groups. None of the children choked. Neither the number, nor the diameter of the administered minitablets have significantly influenced the ability to swallow units. The results show that minitablets administered in several units mixed with jelly food are safe and could be accepted by a pediatric population.
Department of Pharmaceutical Technology, Medical University of Gdansk, 107 Gen. Hallera St., 80-416 Gdansk, Poland.
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Kluk
Department of Pharmaceutical Technology, Medical University of Gdansk, 107 Gen. Hallera St., 80-416 Gdansk, Poland. Electronic address: msznito@gumed.edu.pl.
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Sznitowska
Department and Clinic of Pediatrics, Diabetology and Endocrinology, Medical University of Gdansk, 7 Debinki St., 80-211 Gdansk, Poland.
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Brandt
Department of Pediatrics, Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, 1-6 Nowe Ogrody St., 80-803 Gdansk, Poland.
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Sznurkowska
Department of Pediatrics, Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, 1-6 Nowe Ogrody St., 80-803 Gdansk, Poland.
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Plata-Nazar
Department and Clinic of Pediatrics, Diabetology and Endocrinology, Medical University of Gdansk, 7 Debinki St., 80-211 Gdansk, Poland.
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Mysliwiec
Department of Pediatrics, Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, 1-6 Nowe Ogrody St., 80-803 Gdansk, Poland.
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Kaminska
Department of Pharmaceutical Technology, Medical University of Gdansk, 107 Gen. Hallera St., 80-416 Gdansk, Poland.
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Kotlowska
D000284:Administration, Oral; D000367:Age Factors; D002626:Chemistry, Pharmaceutical; D002652:Child Behavior; D002675:Child, Preschool; D018592:Cross-Over Studies; D003679:Deglutition; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D010865:Pilot Projects; D011044:Poland; D013607:Tablets
D013607:Tablets
Children; Minitablets; Swallowing