Swallowability of Minitablets among Children Aged 6–23 Months: An Exploratory, Randomized Crossover Study

Abstract

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.

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

“…The results of a previous study suggested that mini-tablets may only be suitable for children from 4 years old [ 11 ]. However, the present results suggest that mini-tablets could be a feasible and safe method of drug administration for children as young as 2 years old and are in line with the findings of other studies, including studies that have demonstrated the acceptance of mini-tablets by very young children, including newborns and infants 6 months to 1 year old [ 10 , 12 , 13 , 14 , 15 ].…”

Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products

“…Parents of children 0–<2 y preferred mini-tablets over syrup, and parents of children 2–<6 y preferred mini-tablets (different amounts) and the lower quantity of syrup over the higher syrup volume. These results are in line with the preferences for future drug applications expressed by parents of children between the ages of 6 and 11 months in another study [ 23 ].…”

“…This preference was consistent among all stakeholders, despite some differences in formulation preferences of different stakeholders for the four age groups of pediatric patients. This very important result is in line with several other investigations and studies [ 8 , 9 , 10 , 11 , 12 , 14 , 15 , 16 , 17 , 18 , 23 ] and contrasts with the current practice of administering medicines to children aged 0–<6 y as a liquid formulation. As syrups or other liquid formulations might contain excipients with potential toxicological risks [ 35 ], a switch to alternative dosage forms could not only increase the acceptability but also improve the risk profile.…”

“…For example, in previous studies of this working group, the suitability of the uncoated mini-tablets was demonstrated in various young age groups, including newborns, and also showed superiority compared to syrup [ 9 , 10 , 11 , 12 ]. Other studies have shown the acceptability of mini-tablets in children as well [ 17 , 23 ], which can also be administered in large numbers to achieve higher doses [ 11 ]. Also, very good acceptability and swallowability were shown for bigger tablets (oblong tablets, 2.5 × 6 mm) [ 12 ].…”

A Study on Pharmacokinetics of Acetylsalicylic Acid Mini-Tablets in Healthy Adult Males—Comparison with the Powder Formulation

“…In Japan, powder and fine granules are popular pediatric dosage forms [ 2 ]; however, their taste and roughness present difficulties [ 7 ]. Mini-tablets can circumvent problems associated with syrups, powders, and fine granules, making them easy to develop globally; however, studies on the dosing and acceptability of mini-tablets in pediatric patients have only been conducted using a placebo [ 8 , 9 ].…”