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Theresa Maier

Development of a low-cost infant drug and nutrient delivery system

According to the World Health Organization (WHO), pneumonia, diarrhoea, malaria, meningitis, tetanus, HIV and measles account for more than fifty percent of the 5.9 million child deaths worldwide before the age of five, most of which could be prevented or treated with access to simple and affordable interventions [1]. In alignment with a WHO-led call for new infant medication delivery technologies, the Department of Chemical Engineering and Biotechnology has developed a novel oral drug and nutrient delivery system that supplements breast milk with medication/nutrients consumed by the breastfeeding infant. It comprises a conventional nipple shield, modified to contain an insert that delivers an active pharmaceutical ingredient (API) [2]. An illustration can be found in Figure 1.

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Figure 1: a) Insert (illustrated on the right hand side) and prototype of the drug and nutrient delivery device. b) The insert containing an active pharmaceutical ingredient (API) is placed into the device to enable drug and nutrient delivery into breast milk while breastfeeding.

The device is placed on the mother's breast during breastfeeding, and as milk passes through, it disperses agents into the milk. To date, proof of concept studies using an in-vitro simulation apparatus have been conducted, establishing the feasibility of the device to deliver model compounds from tablet formulations into breast milk [3]. In addition, various dosage forms releasing compounds into breast milk using the drug and nutrient delivery system have been considered, [3-6] and non-clinical user acceptability studies were performed with mothers in Kenya and South Africa [7, 8].

Previous results are encouraging and thus, my PhD project aims to translate the technology into a clinical setting by performing a clinical investigation at Addenbrooke's Hospital. My doctoral work will also focus at investigating drug delivery from fibre inserts, as well as at identifying important system characteristics for its use in developed countries.

The proposed PhD research is a highly interdisciplinary project based on expertise in medical and chemical engineering, product development, human centred design, and paediatrics. It is jointly supervised by the Department of Chemical Engineering and Biotechnology (School of Technology) and the Department of Paediatrics (School of Clinical Medicine).

 

References

[1] UN. IGME. Levels and Trends in Child Mortality: Report 2015. 2015.
[2] S.E. Gerrard. Shielding infant health. TCE Today, 836:26–27, 2011.
[3] S.E. Gerrard, M. Orlu-Gul, C. Tuleu, and N.K.H. Slater. Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants. Journal of pharmaceutical sciences, 102(10):3773–3783, 2013.
[4] S.E. Gerrard, M.L. Baniecki, and D.C. Sokal. A nipple shield delivery system for oral drug delivery to breastfeeding infants: Microbicide delivery to inactivate HIV. International journal of pharmaceutics, 434(1):224–234, 2012.
[5] S.E. Gerrard and A.M. Larson. Reducing infectivity of HIV upon exposure to surfaces coated with N, N-dodecyl, methyl-polyethylenimine. Biotechnology and bioengineering, 110(7):2058–2062, 2013.
[6] R.L. Scheuerle, S. Bruggraber, S.E. Gerrard, R.A. Kendall, C. Tuleu, and N.K.H. Slater. Characterisation of Zinc Drug Delivery from a Nipple Shield Delivery System using a Breastfeeding Simulation Apparatus (in preparation).
[7] K. Israel-Ballard, C. Hart, and F. Thungu. Acceptability of a modified nipple shield device to reduce breast milk transmission of HIV in developing countries: a qualitative study. 2010.
[8] A.D. Flynn. An assessment of infant drug delivery practices to inform the design of the JustMilk Nipple Shield Delivery System: a non-clinical user acceptability study (in preparation).