A close examination of BCRP’s role in lactation and methods for predicting drug distribution into milk

The article, authored by Caroline Sychterz, Hong Shen, Yueping Zhang, Michael Sinz, Amin Rostami-Hodjegan, Brian J. Schmidt, Lu Gaohua, and Aleksandra Galetin, explores the role of the breast cancer resistance protein (BCRP) in lactation and the complexities of predicting drug distribution into breast milk. It highlights that while breastfeeding is the optimal nutritional choice for infants, concerns about medication safety can discourage mothers from breastfeeding. Despite FDA guidance, drug labels often lack clear dosing information for lactating women. The authors stress the significance of physiologically based pharmacokinetic (PBPK) modeling, particularly Lact-PBPK models, to predict how drugs are transported into milk via BCRP. They also introduce innovative tools for assessing BCRP activity, such as riboflavin as a non-invasive biomarker, which could enhance understanding of drug safety during lactation.