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Acceptability of Uncoated Mini-Tablets in Neonates--A Randomized Controlled Trial
Viviane Klingmann1, Annika Seitz1, Thomas Meissner1
1Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital Düsseldorf, Düsseldorf, Germany.
The Journal of Pediatrics
|August 12, 2015
Summary
Drug-free mini-tablets are a safe and effective alternative to syrup for neonates. These solid dosage forms are well-tolerated and easy to swallow, offering a unified administration option for all pediatric age groups.
Area of Science:
- Pediatric pharmacology
- Drug delivery systems
- Neonatal care
Background:
- Syrup is a common administration route for neonates.
- Solid dosage forms offer potential advantages but require age-appropriate evaluation.
- Previous studies established efficacy in older children.
Purpose of the Study:
- To assess the suitability of 2 mm uncoated mini-tablets compared to syrup in neonates.
- To evaluate acceptability and swallowability of mini-tablets in this population.
Main Methods:
- A randomized, prospective cross-over study involving 151 neonates (2-28 days old).
- Comparison of 2 mm uncoated mini-tablets versus 0.5 mL syrup.
- Assessment of acceptance and swallowability as primary endpoints.
Main Results:
- 100% acceptance for both mini-tablets and syrup.
- Mini-tablets demonstrated non-inferior, and even superior, swallowability compared to syrup.
- Both formulations were well-tolerated with no serious adverse events or instances of coughing/inhalation.
Conclusions:
- Uncoated mini-tablets are a viable alternative to syrup for term neonates.
- This formulation bridges the age gap, potentially enabling a single drug form for all pediatric ages.
- Findings support a shift towards solid dosage forms for pediatric medication, aligning with WHO recommendations.
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