Neonatal formulations and additives

Neonatal drug dosing needs to be based on the physiological characteristics of the newborn and pharmacokinetic parameters of the drug. Overall, clearance is lower in neonates when compared to children or adults. In addition, there is already extensive between-individual variability in clearance in the first months of life. As a consequence, there is a need for an appropriate balance between dose, volume, drug manipulations and dose flexibility in neonates that calls for dedicated and tailored formulations. During the development of these formulations, there is also a need to quantify and limit excipient exposure based on the currently available knowledge on their safety and toxicity. Furthermore, focused studies on the clinical pharmacology of excipients in neonates should be conducted. Finally, until tailored vials and formulations become available, compounding practices for drug formulations in neonates should be evaluated to guarantee correct dosing, product stability and safety.

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