Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk

Alshogran, Osama Y.; Dodeja, Prerna; Albukhaytan, Hamdan; Laffey, Taylor; Chaphekar, Nupur; Caritis, Steve; Shaik, Imam H.; Venkataramanan, Raman

doi:10.1007/s40262-024-01374-3

Clin Pharmacokinet

2024

DOI: 10.1007/s40262-024-01374-3

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Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk

Osama Y. Alshogran,

Prerna Dodeja,

Hamdan Albukhaytan

et al.

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Cited by 3 publications

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A tutorial on physiologically based pharmacokinetic approaches in lactation research

Pansari,

Pan,

Almond

et al. 2024

CPT Pharmacom & Syst Pharma

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In breastfeeding mothers, managing medical conditions presents unique challenges, particularly concerning medication use and breastfeeding practices. The transfer of drugs into breast milk and subsequent exposure to nursing infants raises important considerations for drug safety and efficacy. Modeling approaches are increasingly employed to predict infant exposure levels, crucial for assessing drug safety during breastfeeding. Physiologically‐based pharmacokinetic (PBPK) modeling provides a valuable tool for predicting drug exposure in lactating individuals and their infants. This tutorial offers an overview of PBPK modeling in lactation research, covering key concepts, prediction approaches, and best practices for model development and application. We delve into milk composition dynamics and its influence on drug transfer into breast milk, addressing modeling considerations, knowledge gaps, and future research directions. Practical examples and case studies illustrate PBPK modeling application in lactation studies. We demonstrate how prediction algorithms for Milk‐to‐Plasma (M/P) ratios within a PBPK framework can support scenarios lacking clinical lactation data or extend the utility of available lactation clinical data to support further untested clinical scenarios. This tutorial aims to assist researchers and clinicians in understanding and applying PBPK modeling to understand and support clinical scenarios in breastfeeding mothers. Advances in PBPK modeling techniques, along with ongoing research on lactation physiology and drug disposition, promise further insights into drug transfer during lactation.

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A tutorial on physiologically based pharmacokinetic approaches in lactation research

Pansari,

Pan,

Almond

et al. 2024

CPT Pharmacom & Syst Pharma

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Evaluation of mathematical models for predicting medicine distribution into breastmilk - considering biological heterogeneity

Heo,

Butler,

Stamouli Simoncioni

et al. 2024

Front. Pharmacol.

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IntroductionA significant proportion of mothers take medication during the breastfeeding period, however knowledge of infant safety during continued breastfeeding is often limited. Breastmilk exhibits significant physiological heterogeneity, with a range of milk fat (creamatocrit), protein and pH values available within the literature. Mathematical models for the prediction of infant exposure are available and these predict that variable milk physiology will significantly affect accumulation of drugs within the breastmilk. These models are typically validated against limited datasets only, and to the best of our knowledge no widescale review has been conducted which accounts for the heterogeneity of breastmilk.MethodsObserved area under the curve milk-to-plasma (M/P) ratios and physicochemical properties were collected for a diverse range of drugs. The reliability of previously published mathematical models was assessed by varying milk pH and creamatocrit across the physiological range. Subsequently, alternative methods for predicting lipid and protein binding within the milk, and the effect of ionisation and physicochemical properties were investigated.ResultsExisting models mis-predicted >40% of medications (Phase Distribution model), exhibited extreme sensitivity to milk pH (Log-Transformed model) or exhibited limited sensitivity to changes in creamatocrit (LogPo:w model). Alternative methods of predicting distribution into milk lipids moderately improved predictions, however altering the way in which milk protein binding was predicted and the effect of ionisation on this demonstrated little effect. Many drugs were predicted to have a significant range of M/P ratios.DiscussionThese data show that consideration of the biological heterogeneity of breastmilk is important for model development and highlight that increased understanding of the physiological mechanisms underlying distribution within the milk may be essential to continue improving in silico methodologies to support infant and maternal health.

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A Method for Assessing the Quality of Recombinant Human Milk Peptide Analogues

Mekhtieva,

Martynyuk,

Ilyasova

et al. 2024

Pharmacophore

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Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk

Cited by 3 publications

References 169 publications

A tutorial on physiologically based pharmacokinetic approaches in lactation research

A tutorial on physiologically based pharmacokinetic approaches in lactation research

Evaluation of mathematical models for predicting medicine distribution into breastmilk - considering biological heterogeneity

A Method for Assessing the Quality of Recombinant Human Milk Peptide Analogues

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