Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants.
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.
Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge, CB2 3RA, United Kingdom.
Stephen E
SE
Gerrard
Mine
M
Orlu-Gul
Catherine
C
Tuleu
Nigel K H
NK
Slater
D001942:Breast Feeding / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods; D016503:Drug Delivery Systems / Q000379:methods; D005260:Female; D006801:Humans; D007223:Infant; D007774:Lactation / Q000378:metabolism*; D008954:Models, Biological; D009558:Nipples / Q000378:metabolism*; D012235:Rhodamines / Q000378:metabolism; D013607:Tablets / Q000378:metabolism
D012235:Rhodamines; D013607:Tablets; C022027:lissamine rhodamine B
Controlled release/delivery; drug delivery systems; in vitro models; lactation; nipple shield delivery system; oral drug delivery; pediatric