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

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Abstract

Human milk is a remarkable biofluid that provides essential nutrients and immune protection to newborns. Breastfeeding women consuming medications could pass the drug through their milk to neonates. Drugs can be transferred to human milk by passive diffusion or active transport. The physicochemical properties of the drug largely impact the extent of drug transfer into human milk. A comprehensive understanding of the physiology of human milk formation, composition of milk, mechanisms of drug transfer, and factors influencing drug transfer into human milk is critical for appropriate selection and use of medications in lactating women. Quantification of drugs in the milk is essential for assessing the safety of pharmacotherapy during lactation. This can be achieved by developing specific, sensitive, and reproducible analytical methods using techniques such as liquid chromatography coupled with mass spectrometry. The present review briefly discusses the physiology of human milk formation, composition of human milk, mechanisms of drug transfer into human milk, and factors influencing transfer of drugs from blood to milk. We further expand upon and critically evaluate the existing analytical approaches/assays used for the quantification of drugs in human milk.

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Authors and Affiliations

  1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA

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

  2. Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan

    Osama Y. Alshogran

  3. Department of Obstetrics, Gynecology and Reproductive Sciences, School of Medicine, UPMC Magee-Women’s Hospital, Pittsburgh, PA, USA

    Steve Caritis

  4. Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, 3501 Terrace Street, Room 7406, Salk Hall, Pittsburgh, PA, 15261, USA

    Imam H. Shaik

  5. Department of Pathology, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA

    Raman Venkataramanan

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This work is partially funded by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD, Grant no. HD047905 and Grant no. HD096796).

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Osama Y. Alshogran, Prerna Dodeja, Hamdan Albukhaytan, Taylor Laffey, Nupur Chaphekar, Steve Caritis, Imam H. Shaik, and Raman Venkataramanan declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.

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Authors' Contributions

O.A., P.D., H.A., I.S., and R.V. participated in conceptualization; O.A., P.D., H.A., T.L., and I.S. conducted experiments/ data mining; O.A., P.D., and H.A. performed data analysis; O.A., P.D., H.A., N.K., and I.S. prepared figures and tables; and O.A., P.D., H.A., T.L., S.C., I.S., and R.V. wrote/contributed to the manuscript. All authors read and approved the final version of the manuscript.

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Alshogran, O.Y., Dodeja, P., Albukhaytan, H. et al. Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk. Clin Pharmacokinet 63, 561–588 (2024). https://doi.org/10.1007/s40262-024-01374-3

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