ArticleBritish journal of clinical pharmacology2026
Population pharmacokinetic modelling of amoxicillin in human breast milk-A contribution from the ConcePTION project.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
3 citing papers in PubMed.
- Population pharmacokinetic modelling of amoxicillin in human breast milk-A contribution from the ConcePTION project.British journal of clinical pharmacology · 2026Article
- Challenges during clinical lactation studies investigating medicines exposure: experiences from the UmbrelLACT study - a contribution from the ConcePTION project.BMJ paediatrics open · 2026Observational
- Effect of perinatal ampicillin or amoxicillin/clavulanate exposure on maternal and infant gut microbiome, metabolome, and infant responses to the 20-valent pneumococcal conjugate vaccine.Gut microbes reports · 2026Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
aimsAmoxicillin, a widely used β-lactam antibiotic, requires improved pharmacokinetic characterization during breastfeeding. This study used a population pharmacokinetic (PopPK) approach to model amoxicillin concentrations in breast milk, identify variability sources and estimate infant exposure, applying worst-case scenarios.
methodsBreastfeeding mothers receiving amoxicillin for at least 2 days were enrolled. At steady state, three (nearly) paired blood and milk samples were collected between two doses: 15-30 min, 1-2 h and 3-4 h post-dose. Samples were analysed using LC-MS/MS. PopPK modelling was performed with Monolix. Milk-to-plasma (M/P) concentrations ratios and relative infant dose (RID) were evaluated. RID was calculated relative to both adult and paediatric dosing regimens. Monte Carlo simulations estimated infant exposure at high maternal doses (6 g/day).
resultsTwenty-five mother-infant pairs were included. All plasma and milk samples (n = 75/matrix) contained quantifiable amoxicillin. A two-compartment model described the data, with drug transfer from plasma to milk and elimination from milk. Simulated M/P concentrations ratios were 4.1%-5.4%, while observed values ranged from 4.5% to 9.6%. RID based on adult or paediatric dosages remained <0.4%, regardless of measured or simulated concentrations. No adverse effects were reported in breastfed infants.
conclusionsThese findings support the low transfer of amoxicillin into breast milk and align with the absence of adverse effects in breastfed infants, reinforcing its safety during lactation.
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