Abstract
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.
Highlights
Difficulties in Infant Drug DeliveryNew drug delivery systems are urgently needed for the treatment of pediatric diseases, especially in developing countries.[1,2] Each year more than 7.6 million children under 5 years die worldwide from diseases that could often have been prevented if they had access to appropriate forms of simple and affordable medicines.[3]
This study focuses on the influence of fat content and flow rate of milk, and the suction pulse rate of the infant, three factors known to vary significantly between infants and during a single breastfeed
Milk was seen to fill the reservoir of the nipple shield before releasing in pulsed bursts into the collection reservoir (S3) in sync with the increasing vacuum phase induced by P3
Summary
New drug delivery systems are urgently needed for the treatment of pediatric diseases, especially in developing countries.[1,2] Each year more than 7.6 million children under 5 years die worldwide from diseases that could often have been prevented if they had access to appropriate forms of simple and affordable medicines.[3] Liquid formulations are typically the principal method for pediatric drug administration, but are often not practical in developing countries because of sterility issues, high cost, lack of access to refrigeration, and limited shelf life.[4,5,6] They may be unpalatable and contain toxic preservatives and solvents. Solid oral dosage forms for infants are often scaled down from adult doses, and there is currently a debate on the limitations of clinical work performed to demonstrate suitability of the dose to infant.[7,8] Dispersible tablets can be used, but require sterile sources of water and administration devices
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