Verstegen RHJ, Anderson PO, Ito S. Infant drug exposure via breast milk. Br J Clin Pharmacol. 2020;88:4311–27.
Binns C, Lee M, Low WY. The long-term public health benefits of breastfeeding. Asia Pac J Public Health. 2016;28:7–14.
Victora CG, Bahl R, Barros AJD, França GVA, Horton S, Krasevec J, et al. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. The Lancet. 2016;387:475–90.
Hamdan A, Tamim H. The relationship between postpartum depression and breastfeeding. Int J Psychiatry Med. 2012;43:243–59.
Yeung CHT, Ito S, Autmizguine J, Edginton AN. Incorporating breastfeeding-related variability with physiologically based pharmacokinetic modelling to predict infant exposure to maternal medication through breast milk: a workflow applied to lamotrigine. AAPS J. 2021;23:1–11.
Suryavanshi SV, Wang S, Hajducek DM, Hamadeh A, Yeung CHT, Maglalang PD, et al. Coupling pre- and postnatal infant exposures with physiologically based pharmacokinetic modelling to predict cumulative maternal levetiracetam exposure during breastfeeding. Clin Pharmacokinet [Internet]. 2024;63:1735–48.
Article CAS PubMed PubMed Central Google Scholar
Delaney SR, Malik PRV, Stefan C, Edginton AN, Colantonio DA, Ito S. Predicting escitalopram exposure to breastfeeding infants: integrating analytical and in silico techniques. Clin Pharmacokinet. 2018;57:1603–11.
Article CAS PubMed Google Scholar
Garessus EDG, Mielke H, Gundert-Remy U, Frontiers Media S.A. Exposure of infants to isoniazid via breast milk after maternal drug intake of recommended doses is clinically insignificant irrespective of metaboliser status. A physiologically-based pharmacokinetic (PBPK) modelling approach to estimate drug exposure of infants via breast-feeding. Front Pharmacol. 2019;10:1–13.
Yeung CHT, Bertrand KA, Best BM, Capparelli E, Chambers CD, Hajducek DM, et al. Cannabidiol exposure through maternal marijuana use: predictions in breastfed infants. Clin Pharmacokinet. 2023;62:1611–9.
Article CAS PubMed PubMed Central Google Scholar
Yeung CHT, Autmizguine J, Dalvi P, Denoncourt A, Ito S, Katz P, et al. Maternal ezetimibe concentrations measured in breast milk and its use in breastfeeding infant exposure predictions. Clin Pharmacokinet. 2024;63:317–32.
Article CAS PubMed Google Scholar
Walczak-Nowicka ŁJ, Herbet M. Sodium benzoate—harmfulness and potential use in therapies for disorders related to the nervous system: a review. Nutrients. 2022;14:1–25.
Summar ML, Koelker S, Freedenberg D, Le Mons C, Haberle J, Lee HS, et al. The incidence of urea cycle disorders. Mol Genet Metab. 2013;110:179–80.
Article CAS PubMed PubMed Central Google Scholar
Summar M. Current strategies for the management of neonatal urea cycle disorders. J Paediatr. 2001;138:S30–9.
Parmeggiani B, Vargas CR. Oxidative stress in urea cycle disorders: findings from clinical and basic research. Clin Chim Acta. 2018;477:121–6.
Article CAS PubMed Google Scholar
Braissant O. Current concepts in the pathogenesis of urea cycle disorders. Mol Genet Metab. 2010;100:S3-12.
Article CAS PubMed Google Scholar
Herder M. Orphan drug incentives in the pharmacogenomic context: Policy responses in the USA and Canada. J Law Biosci. 2016;3:158–66.
Article PubMed PubMed Central Google Scholar
Kakkilaya A, Shahzad M, Bourgeois FT. FDA approval of orphan drug indications for paediatric patients, 2011-2023. JAMA Pediatr. 2025;179:203.
Article PubMed PubMed Central Google Scholar
MacArthur RB, Altincatal A, Tuchman M. Pharmacokinetics of sodium phenylacetate and sodium benzoate following intravenous administration as both a bolus and continuous infusion to healthy adult volunteers. Mol Genet Metab. 2004;81:67–73.
Ucyclyd Pharma Inc. Ammonul Drug Label [Internet]. Scottsdale, AZ; 2005. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020645lbl.pdf. Accessed 19 Mar 2024.
Häberle J, Burlina A, Chakrapani A, Dixon M, Karall D, Lindner M, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders: first revision. J Inherit Metab Dis. 2019;42:1192–230.
Endo F, Nakamura K, Sano Y, Dote N, Shimizu K, Koumura E. Pharmacokinetics, safety, and tolerability of sodium phenylacetate and sodium benzoate in healthy Japanese volunteers: a phase I, single-center, open-label study. Drug Metab Pharmacokinet. 2023;48:1–6.
Lin YS, Mao WC, Yao NT, Tsai GE. Pharmacokinetics and safety of sodium benzoate, a d-amino acid oxidase (DAAO) Inhibitor, in healthy subjects: a phase I, Open-label Study. Clin Ther. 2022;44:1326–35.
Article CAS PubMed Google Scholar
Kubota K, Ishizaki T. Dose-dependent pharmacokinetics of benzoic acid following oral administration of sodium benzoate to humans. Eur J Clin Pharmacol. 1991;41:363–8.
Article CAS PubMed Google Scholar
Kubota K, Horai Y, Kushida K, Ishizaki T. Determination of benzoic acid and hippuric acid in human plasma and urine by high performance liquid chromatography. J Chromatogr. 1988;425:67–75.
Article CAS PubMed Google Scholar
Green TP, Marchessault RP, Freese DK, Minneapolis M. Disposition of sodium benzoate in newborn infants with hyperammonemia. J Pediatr. 1983;102:785–90.
Article CAS PubMed Google Scholar
Rog AA, van Ginneken CAM. Development of a consistent pharmacokinetic model for the disposition of benzoic acid and hippuric acid in man. Pharm Weekbl Sci. 1982;4:207–207.
Zu K, Pizzurro DM, Lewandowski TA, Goodman JE. Pharmacokinetic data reduce uncertainty in the acceptable daily intake for benzoic acid and its salts. Regul Toxicol Pharmacol. 2017;89:83–94.
Article CAS PubMed Google Scholar
Rohwer JM, Schutte C, van der Sluis R. Functional characterisation of three glycine N-acyltransferase variants and the effect on glycine conjugation to benzoyl–CoA. Int J Mol Sci. 2021;22:1–19.
Schwab AJ, Tao L, Yoshimura T, Simard A, Barker F, Pang AKS, et al. Hepatic uptake and metabolism of benzoate: a multiple indicator dilution, perfused rat liver study. Am J Physiol Gastrointest Liver Physiol. 2001;280:G1124–36.
Article CAS PubMed Google Scholar
Vessey DA, Kelley M, Warren RS. Characterization of the CoA ligases of human liver mitochondria catalyzing the activation of short-and medium-chain fatty acids and xenobiotic carboxylic acids. Biochim Biophys Acta. 1999;1428:455–62.
Article CAS PubMed Google Scholar
Vijay N, Morris ME. Role of monocarboxylate transporters in drug delivery to the brain. Curr Pharm Des. 2014;20:1497–8.
Droździk M, Szeląg-pieniek S, Grzegółkowska J, Łapczuk-romańska J, Post M, Domagała P, et al. Monocarboxylate transporter 1 (MCT1) in liver pathology. Int J Mol Sci. 2020;21:1–12.
Kido Y, Tamai I, Mototsugu O, Suzuki F, Tsuji A. Functional clarification of MCT1- mediated transport of monocarboxylic acids at the blood- brain barrier using in vitro cultured cells and in vivo BUI studies. Pharm Res. 2000;17:1–8.
Ganapathy V, Thangaraju M, Gopal E, Martin PM, Itagaki S, Miyauchi S, et al. Sodium-coupled monocarboxylate transporters in normal tissues and in cancer. AAPS J. 2008;10:193–9.
Article CAS PubMed PubMed Central Google Scholar
Gagic M, Milosevic V, Parojcic J, Cvijic S. Physiologically-based in silico modelling for the assessment of sodium benzoate bioperformance. In: Arhiv za Farmaciju Conference: 11th Central European Symposium on Pharmaceutical Technology. Belgrade, Serbia: Pharmaceutical Association of Serbia; 2016. p. 117–8.
Breitkreutz J, Bornhöft M, Wöll F, Kleinebudde P. Paediatric drug formulations of sodium benzoate: I. Coated granules with a hydrophilic binder. Eur J Pharm Biopharm. 2003;56:247–53.
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