Drug delivery from a solid formulation during breastfeeding-A feasibility study with mothers and infants

PLoS One. 2022 Mar 4;17(3):e0264747. doi: 10.1371/journal.pone.0264747. eCollection 2022.

Abstract

Background: Breastfeeding is critical to health outcomes, particularly in low-resource settings where there is little access to clean water. For infants in their first twelve months of life, the delivery of medications is challenging, and use of oral syringes to deliver liquid formulations can pose both practical and emotional challenges.

Objective: To explore the potential to deliver medicine to infants via a solid formulation during breastfeeding.

Methods: Single center feasibility study within a tertiary level neonatal unit in the UK, involving twenty-six breastfeeding mother-infant dyads. A solid formulation of Vitamin B12 was delivered to infants during breastfeeding. Outcomes included the quantitative change in serum vitamin B12 and assessment of maternal expectations and experiences.

Results: Delivery of Vitamin B12 through a solid formulation that dissolved in human milk did not impair breastfeeding, and Vitamin B12 levels rose in all infants from a mean baseline (range) 533 pg/mL (236-925 pg/mL) to 1871 pg/mL (610-4981 pg/mL) at 6-8 hours post-delivery. Mothers described the surprising ease of 'drug' delivery, with 85% reporting a preference over the use of syringes.

Conclusions: Solid drug formulations can be delivered during breastfeeding and were preferred by mothers over the delivery of liquid formulations via a syringe.

Trial registration: ClinicalTrials.gov NCT03799367.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Breast Feeding* / psychology
  • Feasibility Studies
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Milk, Human
  • Mothers* / psychology
  • Vitamin B 12

Substances

  • Vitamin B 12

Associated data

  • ClinicalTrials.gov/NCT03799367

Grants and funding

University of Cambridge WD Armstrong Trust (no grant number [to TM]), https://www.tech.cam.ac.uk/wd-armstrong-trust-fund University of Cambridge Kurt Hahn Trust (no grant number [to TM]), https://www.iso.admin.cam.ac.uk/grants-and-scholarships/kurt-hahn-trust/awards-german-students German Academic Scholarship Foundation (no grant number [to TM]), https://www.studienstiftung.de/en/ Applicable to all funders above: The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.