Acceptability of minitablets in soft food. A randomised cross-over study in children

Jennifer Claire Duncan¹Rebecca Page¹Janet Clark¹Gabrielle Seddon¹Joy Slater¹Andrea Gill¹Silothabo Dliso²Udeme Ohia²Nikolaos Skoutelis³Leonie Wagner-Hattler⁴Adrian Baumgartner⁴Angela Dischinger⁴Peter Kühl⁴Louise Bracken^1*

• ¹Paediatric Medicines Research Unit (PMRU), Alder Hey Children’s NHS Foundation Trust, Liverpool, United Kingdom
• ²NIHR Alder Hey Clinical Research Facility, Alder Hey Children’s NHS Foundation Trust, Liverpool, United Kingdom
• ³Department of Paediatric Nephrology, Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom
• ⁴Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Grenzacherstr. 124, CH-4058, Basel, Switzerland

Objective To evaluate the acceptability of placebo minitablets mixed with different volumes of soft food in children aged 6 months to 7 years. Methods In this UK hospital-based, randomised cross-over study, children received placebo minitablets in yoghurt or apple sauce. Those under 1 year received one sample; older children received two. All participants were video recorded taking the samples. Minitablet counts (50-135), and soft food volumes (7.5-30 mL) increased with age. Children aged 1 year+ were randomised to 'high' or 'low' soft food volumes for the first sample; parents chose the soft-food amount for younger children. Swallowability was rated (1-5) by researchers, and palatability by independent reviewers ('pleasant', 'neutral', or 'unpleasant'). Palatability and swallowability scores were then combined to assess overall acceptability using the composite endpoint tool. Children aged 4-7 years completed a participant questionnaire. Results 100 children were grouped by age: <2 years (G1, n=16), 2-4 years (G2, n=37), and ≥5 years (G3, n=47). Mean age was 4.2 years; 56% were male; 84% were tablet naïve. Youngest was 9 months old. Yogurt was preferred by 84%. Swallowability was 77% overall, increasing with age (G1: 69%, G2: 73%, G3: 83%). G3 participants consumed more per sample than G1 (at least 80% of minitablets consumed for Samples 1/2, respectively: G3-89%/91% vs G1-69%/62%). 'Pleasant' was the most common palatability rating (48% Sample 1, 52% Sample 2). Some older children reported finding the number of minitablets excessive. Acceptability was 46% (G1), 58% (G2), and 53% (G3), with overall acceptability rated as "high/good" for 54% of participants. Conclusion Minitablets in soft food were generally acceptable for children aged 9 months to 7 years, especially those aged 2-4 years. Swallowability and palatability were good across all age groups. Larger soft-food volumes were often preferred, but both volumes were well tolerated.