ArticleCPT: pharmacometrics & systems pharmacology2021
Prediction of drug concentrations in milk during breastfeeding, integrating predictive algorithms within a physiologically-based pharmacokinetic model.
Article in CPT: pharmacometrics & systems pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 3 of them syntheses that pooled it.
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Who cites it
41 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- A Systematic Review of Published Physiologically Based Pharmacokinetic Models for Drug Excretion Into Human Breastmilk: Knowledge Gaps and Opportunities to Optimize Reporting and Modeling Practices.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Maternal-to-Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines.Clinical pharmacology and therapeutics · 2026Pooled it
- A systematic review on maternal-to-infant transfer of drugs through breast milk during the treatment of malaria, tuberculosis, and neglected tropical diseases.PLoS neglected tropical diseases · 2023Pooled it
- Physiologically based pharmacokinetic modeling of long-acting extended-release naltrexone in pregnant women with opioid use disorder.CPT: pharmacometrics & systems pharmacology · 2024Trial
- Development of a Mechanistic Distribution Model for Predicting Drug Partitioning into Human Milk.Pharmaceutical research · 2026Article
- Codeine and Metabolite Concentrations in the Breastfed Neonate.Paediatric anaesthesia · 2026Review
- PBPK-Based Prediction of Oliceridine Exposure in Breast Milk and Relative Infant Dose During the First 24 h After Cesarean Delivery.Journal of clinical pharmacology · 2026Article
- A White Paper on Advancing Long-Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation.Clinical pharmacology and therapeutics · 2026Review
- Translation of a physiologically-based pharmacokinetic model for dabigatran etexilate to the design of a safety and efficacy study in post-partum women.British journal of clinical pharmacology · 2026Article
- Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk.British journal of clinical pharmacology · 2026Article
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- Scientific Opinion on the application of physiologically based kinetic (PBK) modelling for the quantitative in vitro to in vivo extrapolation (QIVIVE) of developmental neurotoxicity in vitro battery (DNT IVB) data for pesticide active substances.EFSA journal. European Food Safety Authority · 2025Article
- Application of Lactation Physiologically Based Pharmacokinetic Modeling to Predict Milk Exposure of Passively Diffused Drugs.Journal of clinical pharmacology · 2025Article
- Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the ConcePTION Project.CPT: pharmacometrics & systems pharmacology · 2025Article
- Safer breastfeeding with a wearable sensor for monitoring maternal acetaminophen transfer through breast milk.Device · 2025Article
- A Point-of-Care Device for Theophylline Quantification in Human Milk Using Laser-Induced Graphene Electrodes.ACS applied nano materials · 2025Article
- PBPK-Led Assessment of Antimalarial Drug Concentrations in Breastmilk: A Strategy for Optimal Use of Prediction Methods to Guide Decision Making in an Understudied Population.CPT: pharmacometrics & systems pharmacology · 2025Article
- Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025Review
- Transfer of the Oral Gonadotropin-Releasing Hormone Receptor Antagonist Relugolix Into Breast Milk of Healthy Lactating Women.Pharmacology research & perspectives · 2025Article
- Postpartum changes in maternal physiology and milk composition: a comprehensive database for developing lactation physiologically-based pharmacokinetic models.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
There is a risk of exposure to drugs in neonates during the lactation period due to maternal drug intake. The ability to predict drugs of potential hazards to the neonates would be useful in a clinical setting. This work aimed to evaluate the possibility of integrating milk-to-plasma (M/P) ratio predictive algorithms within the physiologically-based pharmacokinetic (PBPK) approach and to predict milk exposure for compounds with different physicochemical properties. Drug and physiological milk properties were integrated to develop a lactation PBPK model that takes into account the drug ionization, partitioning between the maternal plasma and milk matrices, and drug partitioning between the milk constituents. Infant dose calculations that take into account maternal and milk physiological variability were incorporated in the model. Predicted M/P ratio for acetaminophen, alprazolam, caffeine, and digoxin were 0.83 ± 0.01, 0.45 ± 0.05, 0.70 ± 0.04, and 0.76 ± 0.02, respectively. These ratios were within 1.26-fold of the observed ratios. Assuming a daily milk intake of 150 ml, the predicted relative infant dose (%) for these compounds were 4.0, 6.7, 9.9, and 86, respectively, which correspond to a daily ingestion of 2.0 ± 0.5 mg, 3.7 ± 1.2 µg, 2.1 ± 1.0 mg, and 32 ± 4.0 µg by an infant of 5 kg bodyweight. Integration of the lactation model within the PBPK approach will facilitate and extend the application of PBPK models during drug development in high-throughput screening and in different clinical settings. The model can also be used in designing lactation trials and in the risk assessment of both environmental chemicals and maternally administered drugs.
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