ArticleThe AAPS journal2025
Population Pharmacokinetic Modeling of Amoxicillin in Plasma and Milk in Lactating Göttingen Minipigs - A Contribution from the ConcePTION Project.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials.Birth defects research · 2026Article
- Population pharmacokinetic modelling of amoxicillin in human breast milk-A contribution from the ConcePTION project.British journal of clinical pharmacology · 2026Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAmoxicillin is frequently prescribed to peripartum women as prophylaxis and treatment for infection. Despite frequent usage of amoxicillin in lactating women, quantitative evidence regarding its transfer between systemic circulation and breastmilk remains limited. However, such data is fundamentally essential for assessing the safety risk of medicine usage during breastfeeding.
objectiveThis research performed population pharmacokinetic (PopPK) modeling and simulation to characterize the pharmacokinetics of amoxicillin in plasma and breastmilk in lactating Göttingen Minipigs, a physiologically relevant animal model to humans that enables studying medication transfer during lactation.
methodsDemographic characteristics and amoxicillin concentrations in plasma and breastmilk following daily intramuscular doses (7 mg/kg) in 9 minipigs from two studies were included in the PopPK analysis. The milk-to-plasma (M/P) ratio, daily infant dosage (DID), and relative infant dose (RID) were calculated based on the simulated steady-state exposure.
resultsThe final model consisted of a two-compartment distribution with zero-order absorption and linear elimination. The central compartment was deemed as the plasma compartment with time-varying volume of distribution, and linked to the breastmilk compartment via bidirectional first-order transfer. No covariate was included. The developed PopPK model well described amoxicillin in plasma and breastmilk in the lactating Göttingen Minipigs. The predicted M/P ratio, DID, and RID of amoxicillin following the maximal doses were approximately 0.25, 0.11 mg·kg
conclusionsThe model-based simulation indicated minimal amoxicillin exposure to the breastfed piglets, suggesting a low safety risk, which was reinforced by the absence of adverse events in the piglets.
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