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Hospitalised neonates in Estonia commonly receive potentially harmful excipients
Jana Lass1, Kaisa Naelapää, Utpal Shah
1Institute of Microbiology, Tartu University, Tartu, Estonia. jana.lass@kliinikum.ee
Insights
Estonian neonates frequently receive medications containing potentially harmful excipients. This study quantifies exposure to these substances, highlighting the need for better information for healthcare providers.
Area of Science:
- Neonatal pharmacology
- Drug safety
- Pharmaceutical sciences
Background:
- Limited data exists on neonatal exposure to medication excipients.
- Understanding excipient intake is crucial for neonatal patient safety.
Purpose of the Study:
- To quantify excipient exposure in Estonian neonates.
- To classify excipients based on potential neonatal toxicity.
- To assess the extent of exposure to harmful excipients in neonates.
Main Methods:
- Prospective cohort study of neonates (<28 days) admitted to two Estonian hospitals.
- Data collected on prescribed medicines and their excipients.
- Excipients identified and toxicity classified via literature review.
Main Results:
- 1961 prescriptions for 348 neonates were analyzed.
- 123 unique excipients were identified in 83% of prescriptions.
- 47% of excipients were potentially or known to be harmful; 97% of neonates received at least one such excipient.
Conclusions:
- Hospitalized neonates in Estonia are commonly exposed to a wide range of medication excipients.
- There is a need for quantitative excipient data for pharmacists and neonatologists.
- This information can aid in medicine selection and adverse effect monitoring.
Background:
Information on the neonatal exposure to excipients is limited. Our aim was to describe the extent of excipient intake by Estonian neonates; to classify the excipients according to potential neonatal toxicity and thereby to measure the extent of exposure of neonates to potentially harmful excipients.
Methods:
A prospective cohort study that recorded all medicines prescribed to patients aged below 28 days admitted to Tartu University Hospital from 01.02-01.08 2008 and to Tallinn Children's Hospital from 01.02- 01.08 2009 was conducted. Excipients were identified from Summaries of Product Characteristics and classified according to toxicity following a literature review.
Results:
1961 prescriptions comprising 107 medicines were written for 348/490 neonates admitted. A total of 123 excipients were found in 1620 (83%) prescriptions and 93 (87%) medicines. 47 (38%) of these excipients were classified as potentially or known to be harmful to neonates. Most neonates (97%) received at least one medicine (median number 2) with potentially or known to be harmful excipient. Parabens were the most commonly used known to be harmful excipients and sodium metabisulphite the most commonly used potentially harmful excipient, received by 343 (99%) and 297 (85%) of treated neonates, respectively.
Conclusions:
Hospitalised neonates in Estonia are commonly receiving a wide range of excipients with their medication. Quantitative information about excipients should be made available to pharmacists and neonatologists helping them to take into account excipient issues when selecting medicines and to monitor for adverse effects if administration of medicines containing excipients is unavoidable.
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