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Can preschool-aged children swallow several minitablets at a time? Results from a clinical pilot study
A Kluk1, M Sznitowska1, A Brandt2
1Department of Pharmaceutical Technology, Medical University of Gdansk, 107 Gen. Hallera St., 80-416 Gdansk, Poland.
Insights
Minitablets, a novel oral drug formulation for children, were found to be safe and accepted by young children when administered in jelly. Most children could swallow multiple minitablets without chewing, indicating suitability for pediatric use.
Area of Science:
- Pediatric Pharmacology
- Drug Delivery Systems
- Formulation Science
Background:
- Minitablets are a novel solid dosage form designed for pediatric patients aged 1-6 years.
- Previous research indicates infants can swallow single minitablets.
- The acceptance of multiple minitablets in young children requires further investigation.
Purpose of the Study:
- To evaluate the acceptance and swallowing ability of minitablets in children aged 2 and 3 years.
- To assess the safety of administering multiple minitablets.
- To determine if age, gender, or minitablet characteristics affect swallowing ability.
Main Methods:
- Thirty-two 2-year-olds and twenty-eight 3-year-olds participated in the study.
- Children were asked to swallow placebo minitablets (2mm or 3mm) mixed in fruity jelly.
- Swallowing success, with or without chewing, was recorded.
Main Results:
- 75% of 2-year-olds and 93% of 3-year-olds swallowed minitablets.
- 57% of all children swallowed all units without chewing.
- No statistically significant differences were found based on age or gender; no choking occurred.
Conclusions:
- Minitablets administered in multiple units within jelly are safe for pediatric populations.
- This formulation approach demonstrates good acceptance in young children.
- Minitablets show promise as a viable drug delivery system for pediatrics.
Abstract:
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.
