JustMilk - Development of an Infant Nipple Shield Drug Delivery System Used During Breastfeeding

Organization: 
University of Cambridge (on behalf of Justmilk)
Organization Location: 
Cambridge, Cambridgeshire, UK

New drug delivery methods for infants are needed in low- and middle-income countries. Each year over three million babies die within the first month after birth, with the risk of death highest during the initial hours and days. Most of these deaths are easily preventable by early administration of drugs or nutrients [WHO/PMNCH "Millennium Development Goal 4" Fact Sheet, 2011]. We propose to develop a low-cost Nipple Shield Delivery System (NSDS) to administer drugs or nutrients to breastfeeding infants via easily disintegrating tablets within a modified nipple shield. A wide-range of active pharmaceutical ingredients (APIs) could be delivered to infants using the NSDS such as antibiotics, antimalarials, antiretrovirals, vitamins, nutrients, and probiotics. Use of the NSDS would empower a breastfeeding mother during the early postnatal period by allowing her to personally administer medicines in a natural setting. This system can provide a novel method for accurately administering drugs and nutrients to breastfeeding infants. We expect this to improve access to drug interventions during the early postnatal period, which could prevent millions of deaths per year. Our system offers advantages over currently available methods for infant drug administration like liquid formulations or dispersible tablets. Liquid formulations have the following problems: high-cost, refrigeration requirements, accurate dosing difficulties, unpalatability, and the potential presence of harmful excipients. Dispersible tablets must be dissolved in potable water in a clean container, and also have issues with accurate dosing. No ideal drug delivery method exists, and the NSDS addresses each of these issues.

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