Mini-tablets as an alternative galenic formulation for neonates

In the field of paediatrics the lack of evidence-based knowledge about treatment options for children is still remarkably high, which may result in administration of inaccurate dosages and inappropriate formulations of drugs in young patients. This problem occurs even more in neonates, the most vulnerable age group. As a result, an off-label drug use of up to 90% in Neonatal Intensive Care Units (NICUs) has been estimated.

Currently, oral medication is given to neonates in the form of liquid solutions or syrup. This has a high potential of inaccurate dosing and therefore may result in over- or underdosing. In addition sometimes harmful ingredients and bulking agents are used to create the syrups. Obviously, there is a need to investigate appropriate, age-adapted galenic formulations even for the youngest.

In the last years there have been many approaches by the European Medicines Agency (EMA) and World Health Organization (WHO) to undertake clinical pharmaceutical trials involving children more attractive and therefore to increase the evidence-based knowledge of paediatric medication. Nevertheless, there is still a huge need for clinical studies especially in the neonatal period. Our study group of the Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie of the Universitätsklinikum Düsseldorf has already performed 2 trials with 355 children aged 0.5 to 6 years, providing data that the acceptability as well as the swallowability of mini tablets is higher in these age groups compared to, for example, syrup.

Based on a lack of data investigating acceptability and swallowability of mini tablets in neonates, the trial team, including the writer of this thesis, has performed a study involving 151 neonates with the aim to close the gap in factual knowledge about this age group.

The trial could not only show that neonates accept the mini-tablets (100%, 95% CI: 97,6%-100,0%) but also that the swallowability is significantly higher in mini- tablets than in syrup (Δ10%; 95% CI 1.37%-19.34%; p=0.0315).

In conclusion, it can be said that neonates are able to swallow mini-tablets safely, which makes them a considerable alternative to other galenic formulations like syrup. Download the full thesis here: dissertation-a-seitz-minitabletten-final.pdf