Substitution as a Strategy to Improve Excipient Exposure in Neonates: One Piece of the Puzzle
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Since extensive variability is the key characteristic of neonatal pharmacology despite an overall low elimination capacity, this should translate in drug formulations to low, adjustable and flexible dosing to maintain dose accuracy. This observation is not limited to the active compounds, but also applies to excipients [1, 2].
In this issue of the journal, Nellis et al. quantified the potential impact of systematic product substitution within Europe as a strategy to reduce exposure to potentially harmful excipients (i.e. parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol and ethanol) in neonates . The authors hereby explored the between-country variability in exposure to excipients in formulations administered to 726 neonates in 21 different European countries. Using availability of the same active pharmaceutical ingredient with a similar dosage form (but not similar strength/concentration) as prerequisites, substitution potentially...
KeywordsPropylene Glycol Poloxamer Systematic Strategy Flexible Dose Saccharin Sodium
The clinical research of K Allegaert was supported by the Fund for Scientific Research, Flanders (fundamental clinical investigatorship 1800214N) and the research activities are further facilitated by the agency for innovation by Science and Technology in Flanders (IWT) through the SAFEPEDRUG project (IWT/SBO 130033).
Compliance with Ethical Standards
Conflict of interest
K. Allegaert and I. Spriet declare that they have no relevant conflicts of interest.
Source of funding
No sources of funding were used to support the writing of this manuscript.
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