Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial

Objectives

Reliable pediatric pharmacotherapy in all age groups requires the availability of age-appropriate drug administration. Orodispersible films (ODF) are a promising pediatric oral dosage form. ODFs would meet relevant targets: one dosage form matching the full range of pediatric patients, a minimum of non-toxic excipients, a stable drug formulation easily to be produced. However, there is a lack of reliable data on ODFs’ acceptability, swallowability and palatability, especially in young children. The primary objective was to demonstrate non-inferiority in acceptability of a drug-free ODF in comparison to glucose syrup in children aged below one year. Secondary objectives were swallowability and palatability of the two formulations.

Study design

The study was performed in an open, randomized, two-way cross-over design with three age groups: 2–28 days, 29 days–5 months, 6–12 months. 150 children (N = 50 per age group) were randomized to the order of receiving the ODF (2 × 3 cm) and age-adapted amounts of glucose syrup (0.5–3 mL). Deglutition and swallowing were assessed according to predefined evaluation criteria. The application of the formulations was documented by video to evaluate the palatability.

Results

The primary objective was confirmed: Non-inferiority of the acceptability of an ODF compared to syrup was demonstrated, even superiority of the ODF was shown (p < 0.0001). The secondary endpoints demonstrated positive results including the superior swallowability of the ODF in comparison to syrup (p < 0.0001). The palatability assessments were in favor of the ODF.