Therapeutic delivery from a solid formulation during breastfeeding: a feasibility study

ABSTRACT Background Enteral drug and nutrient delivery to breastfed infants depends on the use of oral syringes and liquid formulations. This can pose both practical and emotional challenges to drug delivery. Objectives The presented study aimed to explore the potential of using solid formulations for therapeutic delivery during breastfeeding. Methods Single centre feasibility study within a tertiary level neonatal unit in the UK, involving twenty-six breastfeeding mother-infant dyads. Vitamin B12 was delivered to infants during breastfeeding from a solid formulation within a commercial silicon nipple shield. Outcomes included the quantitative measurement of change in serum vitamin B12 and a mixed methods assessment of maternal expectations and experiences. Results Participants described the surprising ease of ‘drug’ delivery, with no negative impact on breastfeeding behaviour or sensation reported. Vitamin B12 levels rose on average from a baseline of 533 pg/mL (236 - 925 pg/mL) to 1871 pg/mL (610 – 4981 pg/mL) at 6 - 8 hours post-delivery. All mothers expressed their support for this approach, 85% a preference over the use of oral syringes. Reasoning for support related to the reduced medicalisation of this procedure compared to the use of oral syringes, and a desire for choices in relation to their infants’ health. Conclusions This study demonstrated that therapeutic delivery from a solid formulation within a nipple shield was feasible and acceptable to mothers and infants.