Abstract
A Therapeutic Nipple Shield (TNS) was previously developed to respond to the global need for new infant therapeutic delivery technologies. However, the release efficiency for the same Active Pharmaceutical Ingredient (API) from different therapeutic matrices within the TNS formulation has not yet been investigated. To address this, in-vitro release of elemental zinc into human milk from two types of Texel non-woven fibre mats of varying thickness and different gram per square meter values, placed inside the TNS was explored and compared to the release from zinc-containing rapidly disintegrating tablets. In-vitro delivery was performed by means of a breastfeeding simulation apparatus, with human milk flow rates and suction pressure adjusted to physiologically relevant values, and release was quantified using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). It was found that a total recovery of 62–64 % elemental zinc was obtained after the human milk had passed through the fibre insert, amounting to a 20–48% increase compared to previous zinc delivery studies using rapidly disintegrating tablets within the TNS. This indicates that non-woven Texel fibre mats were identified as the superior dosage form for oral zinc delivery into human milk using a TNS.
| Original language | English |
|---|---|
| Pages (from-to) | 290-299 |
| Number of pages | 10 |
| Journal | International Journal of Pharmaceutics |
| Volume | 537 |
| Issue number | 1-2 |
| Early online date | 27 Dec 2017 |
| DOIs | |
| Publication status | Published - 15 Feb 2018 |
Funding
This work was supported by 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 ]. Theresa Maier (T.M.) was supported through academic scholarships by the WD Armstrong Trust, University of Cambridge , and the German National Merit Foundation, Rebekah Scheuerle (R.L.S.) through a Gates Cambridge Trust scholarship , and Sylvaine Bruggraber (S.F.A.B.) through the Medical Research Council [grant number MC_US_A090_0008/Unit Program number U1059 ]. We thank Gillian Weaver, manager of the Queen Charlotte’s and Chelsea Hospital Milk Bank (Imperial College Healthcare NHS Trust) for enabling this study by providing human milk samples, Jeremy Skepper and Karin Muller (Cambridge Advanced Imaging Centre) for helping to conduct SEM and EDX analysis, and Stephen Gerrard for having previously built the breastfeeding simulation apparatus and developed the NDSD nipple shield design used in this study.
Keywords
- breastfeeding
- human milk
- medication systems
- oral delivery
- pediatrics
- X-ray micro computed tomography