Background and Importance Despite growing interests for the use of excipients with described toxicities (excipients of interest., EOI) in children and neonates, even today the lack of paediatric data makes it difficult to establish precise recommendations about quantitative levels of EOI in commercialised paediatric formulations.

Aim and Objectives The primary objective of this work is to identify the EOI present in oral liquid forms used in paediatric departments. The secondary endpoint is to quantify the EOI exposure for often-prescribed molecules (originator formulations and generic brands) used in recommended posology ranges, for different age categories.

Material and Methods A review of medications used in French hospitals has allowed establishing a list of oral liquid forms used for paediatrics and neonatology inpatients. The formulation of each medication has been examined using the summaries of product characteristics (SmPC). Ten of the most prescribed molecules have been selected concerning princeps and generics formulations for a total of 31 formulations. EOI exposure has been calculated and STEP Database and European Médicine Agency (EMA) recommendations were used to evaluate the exposure levels.

Results The analysis involved 219 formulations including 123 active molecules and 140 excipients. Sixteen excipients were present in above 10% of the formulations and nine of them are recognised as EOI (ethanol, propylene glycol, glycerol, sodium benzoate, methyl and propyl paraben, aspartame, sorbitol, saccharose). A total of 95% of all studied formulations involve at least one EOI. The amounts of EOI found in the 10 studied molecules outcome the recommended levels for 45% of the 31 formulations. A rate of 73% of the drugs with neonatalogy marketing authorisation include at least one excipient not recommended in this age category.

Conclusion and Relevance Pediatric and neonates inpatients are receiving a wide range of harmful excipients, among others through the administration of oral liquid forms. Although specific studies tend to enlarge the knowledge about specific use and toxicity of the excipients in paediatrics, too little remains, especially in preterm. When EOI cannot be avoided, quantitative information about their amount in drug formulations should be easily known to help physicians and pharmacist to select the most appropriate drugs and anticipate possible adverse effects or adapt drugs posology.

Conflict of Interest No conflict of interest.