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J Pharm Sci. 2013 Oct;102(10):3773-83. doi: 10.1002/jps.23688. Epub 2013 Aug 11.

Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants.

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Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge, CB2 3RA, United Kingdom.


An apparatus was designed to mimic lactation from a human breast. It was used to determine the influence of milk fat content and flow rate, and suction pulse rate of a breastfeeding infant upon the release of a model compound from a nipple shield delivery system (NSDS). The NSDS would be worn by a mother to deliver drugs and nutrients to her infant during breastfeeding. Sulforhodamine B dye (SB) was used as model compound and formulated as a dispersible tablet to be placed within the NSDS. Increasing suction pulse rate from 30 to 120 pulses/min clearly correlated with increased cumulative release of SB for the same volume of milk passed through the NSDS. No distinct correlation was found between flow rates (1, 5, and 8 mL/min) and SB release, possibly because of competing factors controlling release rate at different flow rates. A highly similar SB release rate into two fat content fluids (2.9 and 4.2 wt %) was observed for identical flow conditions. This proof of concept study outlines a novel method to mimic lactation from a breast, and future studies will lead to effective methods to identify key physiological factors that influence drug release from a NSDS.


Controlled release/delivery; drug delivery systems; in vitro models; lactation; nipple shield delivery system; oral drug delivery; pediatric

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