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建立模型以研究影响乳头盾给药系统向母乳喂养婴儿输送药物的生理因素。

Modeling the physiological factors that affect drug delivery from a nipple shield delivery system to breastfeeding infants.

机构信息

Department of Chemical Engineering and Biotechnology, BioScience Engineering Research Group, University of Cambridge, New Museums Site, Pembroke Street, Cambridge, CB2 3RA, United Kingdom.

出版信息

J Pharm Sci. 2013 Oct;102(10):3773-83. doi: 10.1002/jps.23688. Epub 2013 Aug 11.

DOI:10.1002/jps.23688
PMID:23934768
Abstract

An apparatus was designed to mimic lactation from a human breast. It was used to determine the influence of milk fat content and flow rate, and suction pulse rate of a breastfeeding infant upon the release of a model compound from a nipple shield delivery system (NSDS). The NSDS would be worn by a mother to deliver drugs and nutrients to her infant during breastfeeding. Sulforhodamine B dye (SB) was used as model compound and formulated as a dispersible tablet to be placed within the NSDS. Increasing suction pulse rate from 30 to 120 pulses/min clearly correlated with increased cumulative release of SB for the same volume of milk passed through the NSDS. No distinct correlation was found between flow rates (1, 5, and 8 mL/min) and SB release, possibly because of competing factors controlling release rate at different flow rates. A highly similar SB release rate into two fat content fluids (2.9 and 4.2 wt %) was observed for identical flow conditions. This proof of concept study outlines a novel method to mimic lactation from a breast, and future studies will lead to effective methods to identify key physiological factors that influence drug release from a NSDS.

摘要

设计了一种装置来模拟人乳的泌乳。它被用于确定母乳中脂肪含量和流速以及婴儿吸吮脉冲率对乳头保护套给药系统(NSDS)中模型化合物释放的影响。母亲在母乳喂养期间可以佩戴 NSDS 来向婴儿输送药物和营养物质。磺基罗丹明 B 染料(SB)被用作模型化合物,并被配制成可分散片剂,放置在 NSDS 中。相同体积的奶液通过 NSDS 时,吸吮脉冲率从 30 增加到 120 次/分钟,与 SB 的累积释放明显相关。在相同的流速(1、5 和 8 mL/min)下,没有发现 SB 释放与流速之间存在明显的相关性,这可能是由于在不同流速下控制释放速率的竞争因素所致。在相同的流速条件下,观察到两种脂肪含量的液体(2.9 和 4.2wt%)中 SB 的释放率非常相似。这项概念验证研究概述了一种从乳房模拟泌乳的新方法,未来的研究将有助于确定影响 NSDS 中药物释放的关键生理因素的有效方法。

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