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哺乳期经固体剂型给药 - 一项针对母亲和婴儿的可行性研究。

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

机构信息

Department of Chemical Engineering and Biotechnology, University of Cambridge, West Cambridge Site, Cambridge, United Kingdom.

Department of Paediatrics, University of Cambridge, Cambridge, United Kingdom.

出版信息

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.

摘要

背景

母乳喂养对健康结果至关重要,特别是在资源匮乏的环境中,那里几乎无法获得清洁水。对于生命的头 12 个月的婴儿来说,药物的输送是具有挑战性的,使用口服注射器输送液体制剂既具有实际挑战,也具有情感挑战。

目的

探索在母乳喂养期间通过固体制剂向婴儿输送药物的可能性。

方法

英国一家三级新生儿病房内的单中心可行性研究,涉及 26 对母乳喂养的母婴对。在母乳喂养期间向婴儿输送维生素 B12 的固体制剂。结果包括血清维生素 B12 的定量变化以及对母亲的期望和经验的评估。

结果

通过在人乳中溶解的固体制剂输送维生素 B12 不会损害母乳喂养,所有婴儿的维生素 B12 水平均从平均基线(范围)533pg/mL(236-925pg/mL)上升至 6-8 小时后 1871pg/mL(610-4981pg/mL)。母亲们描述了“药物”输送的惊人简便性,85%的母亲表示更喜欢使用注射器。

结论

固体药物制剂可以在母乳喂养期间输送,并且比通过注射器输送液体制剂更受母亲的青睐。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dade/8896718/d8fda5adc7d7/pone.0264747.g001.jpg

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