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

Theresa Maier, Paula Peirce, Laura Baird, Sophie L Whitehouse, Nigel K H Slater, Kathryn Beardsall, Theresa Maier, Paula Peirce, Laura Baird, Sophie L Whitehouse, Nigel K H Slater, Kathryn Beardsall

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.

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Consort diagram.
Fig 1. Consort diagram.

References

    1. Maier T, Bonner O, Peirce P, Slater NKH, Beardsall K. Drug and nutrient administration on the NICU—is delivery during breastfeeding an alternative to oral syringes? J Neonatal Nursing, 2020. Jun 1;26(3):152–6.
    1. Helms RA, Quan DJ. Textbook of therapeutics: drug and disease management. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2006. 336–338 p.
    1. Maier T, Scheuerle RL, Markl D, Bruggraber S, Zeitler A, Fruk L, et al.. Zinc delivery from non-woven fibres within a therapeutic nipple shield. Int J Pharm. 2018;537(1–2):290–9. doi: 10.1016/j.ijpharm.2017.12.042
    1. Maier T, Kerbs A, Fruk L, Slater NKH. Iron delivery from liquid-core hydrogels within a therapeutic nipple shield. Eur J Pharm Sci. 2019;131:119–26. doi: 10.1016/j.ejps.2019.01.032
    1. Allen LH. Vitamin B12. Adv Nutr. 2012;3(1):54–5. doi: 10.3945/an.111.001370
    1. Dworkin SL. Sample size policy for qualitative studies using in-depth interviews. Arch Sex Behav. 2012;41(6):1319–20. doi: 10.1007/s10508-012-0016-6
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Heal Care. 2007;19(6):349–57. doi: 10.1093/intqhc/mzm042
    1. Carkeet C, Dueker SR, Lango J, Buchholz BA, Miller JW, Green R, et al.. Human vitamin B12 absorption measurement by accelerator mass spectrometry using specifically labeled 14C-cobalamin. Proc Natl Acad Sci. 2006;103(15):5694–9. doi: 10.1073/pnas.0601251103
    1. Patton MQ. Qualitative research and evaluation methods. 3rd ed. Thousand Oaks: SAGE Publications; 2002.
    1. Richards L. Handling qualitative data: a practical guide. 3rd ed. London: SAGE Publications; 2014.
    1. Vaismoradi M, Turunen H. Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study. Nurs Heal Sci. 2013;15(3):398–405. doi: 10.1111/nhs.12048
    1. Billingham SA, Whitehead AL, Julious, SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Medical Research Methodology. 2013; 13 (1): 104.
    1. Haiden N, Klebermass K, Cardona F, Schwindt J, Berger A, Kohlhauser-Vollmuth C, et al.. A randomized, controlled trial of the effects of adding vitamin B12 and folate to erythropoietin for the treatment of anemia of prematurity. Pediatrics. 2006; 118(1): 180–188. doi: 10.1542/peds.2005-2475
    1. Worthington-White DA, Behnke M, Gross S. Premature infants require additional folate and vitamin B-12 to reduce the severity of the anemia of prematurity. The American Journal of Clinical Nutrition. 1994; 60(6): 930–935. doi: 10.1093/ajcn/60.6.930
    1. Hart CW, Israel-Ballard KA. Acceptability of a nipple shield delivery system administering antiviral agents to prevent mother-to-child transmission of HIV through breastfeeding. J Hum Lact. 2015;31(1):68–75. doi: 10.1177/0890334414559980
    1. Scheuerle RL, Bruggraber SFA, Gerrard SE, Kendall RA, Tuleu C, Slater NKH. Characterisation of zinc delivery from a nipple shield delivery system using a breastfeeding simulation apparatus. PLoS One. 2017;12(2):e0171624. doi: 10.1371/journal.pone.0171624
    1. Gerrard SE, Larson AM. Reducing infectivity of HIV upon exposure to surfaces coated with N, N-dodecyl, methyl-polyethylenimine. Biotechnol Bioeng. 2013;110(7):2058–62. doi: 10.1002/bit.24867
    1. Chertok IRA. Reexamination of ultra-thin nipple shield use, infant growth and maternal satisfaction. Journal of Clinical Nursing. 2009; 18(21):2949–2955. doi: 10.1111/j.1365-2702.2009.02912.x
    1. Chertok IRA, Schneider J, Blackburn S. A pilot study of maternal and term infant outcomes associated with ultrathin nipple shield use. Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2006; 35(2):265–272. doi: 10.1111/j.1552-6909.2006.00028.x
    1. Meier PP, Brown LP, Hurst NM, Spatz DL, Engstrom JL, Borucki LC, et al.. Nipple shields for preterm infants: effect on milk transfer and duration of breastfeeding. Journal of Human Lactation. 2000; 16(2):106–114. doi: 10.1177/089033440001600205
    1. Arockiasamy V, Holsti L, Albersheim S. Fathers’ experiences in the neonatal intensive care unit: a search for control. Pediatrics. 2008;121(2):e215–22. doi: 10.1542/peds.2007-1005
    1. Cescutti-Butler L, Galvin K. Parents’ perceptions of staff competency in a neonatal intensive care unit. J Clin Nurs. 2003;12(5):752–61. doi: 10.1046/j.1365-2702.2003.00783.x
    1. Lewandowski LA, Tesler MD. Family-centered care: Putting it into action: the SPN/ANA guide to family-centered care. 1st ed. Washington: American Nurses Association; 2003.
    1. Jiang S, Warre R, Qiu X, O’Brien K, Lee SK. Parents as practitioners in preterm care. Early Hum Dev. 2014;90(11):781–5. doi: 10.1016/j.earlhumdev.2014.08.019
    1. Kennell J, McGrath S. Starting the process of mother-infant bonding. Acta Paediatr. 2007;94(6):775–7.
    1. Strand TA, Ulak M, Chandyo RK, Kvestad I, Hysing M, Shrestha M, et al.. The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial. Trials. 2017;18(1):187. doi: 10.1186/s13063-017-1937-0
    1. Lopez FL, Ernest TB. Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert Opin Drug Deliv. 2015;12(11):1727–40. doi: 10.1517/17425247.2015.1060218
    1. Cosmi VD, Scaglioni S, Agostoni C. Early taste experiences and later food choices. Nutrients. 2017;9(2):107. doi: 10.3390/nu9020107
    1. Bravi F, Wiens F, Decarli A, Pont AD. Impact of maternal nutrition on breast-milk composition: a systematic review. Am J. 2016;104(3):646–62. doi: 10.3945/ajcn.115.120881
    1. Bennett SM, Zhou L, Hayes JE. Using milk fat to reduce the irritation and bitter taste of ibuprofen. Chemosens Percept. 2012;5(3–4):231–6. doi: 10.1007/s12078-012-9128-6

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