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.

Highlights

  • Zinc is an essential micronutrient for paediatric health

  • Release of zinc from the nipple shield delivery system (NSDS) requires the active pharmaceutical ingredient (API) to have either dissolved into the human milk, or to have disintegrated enough into for it to pass through the holes of the NSDS

  • Zinc release was quantified in breast milk using a novel inductively coupled plasma optical emission spectrometry (ICP-OES) technique, unique because it did not require sample digestion via microwave

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Summary

Introduction

Zinc is an essential micronutrient for paediatric health It is especially crucial during rapid growth due to its important role in cell division, metabolism, and protein synthesis [1][2][3]. It is needed for proper immune system functioning [2]. The website for this grant is http://www. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

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