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Mechanistic Analysis and Optimisation of Nipple Shield Drug Delivery Devices


Type

Thesis

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Authors

Marks, William 

Abstract

The work in this dissertation focused on delivering a nipple shield drug delivery device that is ready for clinical trials with the hope of making a positive impact on the health of neonates, infants, and paediatrics five and younger worldwide. In order to do that, the tools and techniques necessary to understand the hydrodynamics of the system needed to be developed, and then used, to fully grasp the impact of the number of effluent holes, the size and positioning of those effluent holes, and the shape and form factor of the nipple shield and any potential internal geometry contained within. Next, it was essential to understand the landscape of potential use cases for the device, including the populations of neonates, infants and paediatrics five and younger worldwide, but particularly in low- and middle-income countries, where the impact and burden of disease and mortality is highest. This involved collecting and analyzing data on such infant mortality and incidence of disease globally, and then determining and compiling a list of the highest impact medications that could be used within the nipple shield drug delivery device. Finally, it was essential to test real-world impact of the device, so three of the highest impact medications were selected for testing. Tablet dissolution and disintegration was studied using NMR spectroscopy, and a breastfeeding mimic simulation was created to test delivery of the three designated medications within the temporal and volumetric constraints of a single average breastfeeding session. Conclusions based on the results of each set of experiments were drawn, leading to an analysis of the evaluated nipple shield designs and features in preparation for clinical trials.

Description

Date

2018-09-28

Advisors

Drumright, Lydia

Keywords

medical device, innovation, hydrodynamics, global health, public health, fluid dynamics, LMIC

Qualification

Doctor of Philosophy (PhD)

Awarding Institution

University of Cambridge