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Characterisation of zinc delivery from a nipple shield delivery system using a breastfeeding simulation apparatus

Published version
Peer-reviewed

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Authors

Scheuerle, RL 
Bruggraber, SFA 
Gerrard, SE 
Kendall, RA 
Tuleu, C 

Abstract

Zinc delivery from a nipple shield delivery system (NSDS), a novel platform for administering medicines to infants during breastfeeding, was characterised using a breastfeeding simulation apparatus. In this study, human milk at flow rates and pressures physiologically representative of breastfeeding passed through the NSDS loaded with zinc-containing rapidly disintegrating tablets, resulting in release of zinc into the milk. Inductively coupled plasma optical emission spectrometry was used to detect the zinc released, using a method that does not require prior digestion of the samples and that could be applied in other zinc analysis studies in breast milk. Four different types of zinc-containing tablets with equal zinc load but varying excipient compositions were tested in the NSDS in vitro. Zinc release measured over 20 minutes ranged from 32-51% of the loaded dose. Total zinc release for sets tablets of the same composition but differing hardness were not significantly different from one another with P = 0.3598 and P = 0.1270 for two tested pairs using unpaired t tests with Welch's correction. By the same test total zinc release from two sets of tablets having similar hardness but differing composition were also not significantly significant with P = 0.2634. Future zinc tablet composition and formulation optimisation could lead to zinc supplements and therapeutics with faster drug release, which could be administered with the NSDS during breastfeeding. The use of the NSDS to deliver zinc could then lead to treatment and prevention of some of the leading causes of child mortality, including diarrheal disease and pneumonia.

Description

Keywords

Breast Feeding, Drug Delivery Systems, Humans, Nipples, Protective Devices, Tablets, Zinc

Journal Title

PLoS One

Conference Name

Journal ISSN

1932-6203
1932-6203

Volume Title

12

Publisher

PLOS
Sponsorship
This work was made possible for all authors through the support of the Saving Lives at Birth partners: the United States Agency for International Development (USAID), the Government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada and the UK Department for International Development (DFID) through the Saving Lives at Birth Award Scheme, grant number 0454-03. The website for the award scheme is https://savinglivesatbirth.net/. We also thank the Medical Research Council (grant number MC_US_A090_0008/Unit Programme number U1059) for their support of Sylvaine Bruggraber (S.F.A.B.). The website for this grant is http://www.mrc-ewl.cam.ac.uk/. The Gates Cambridge Trust is also thanked for their funding of Rebekah Scheuerle (R.L.S) through an academic scholarship. Their website is https://www.gatescambridge.org/. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.