University of Cambridge, Department of Chemical Engineering and Biotechnology, West Cambridge Site, Philippa Fawcett Drive, Cambridge CB3 0AS, United Kingdom; University of Cambridge, Department of Paediatrics, Cambridge Biomedical Campus, Cambridge CB2 0QQ, United Kingdom.
University of Cambridge, Department of Chemical Engineering and Biotechnology, West Cambridge Site, Philippa Fawcett Drive, Cambridge CB3 0AS, United Kingdom.
Eur J Pharm Sci. 2019 Apr 1;131:119-126. doi: 10.1016/j.ejps.2019.01.032. Epub 2019 Jan 30.
To aid oral therapeutic administration to infants, a novel delivery technology, referred to as a Therapeutic Nipple Shield (TNS), was previously developed. It consists of a silicone nipple shield device and a dosage form containing a therapeutic (or Active Pharmaceutical Ingredient (API)) to enable delivery during breastfeeding. A range of dosage forms were investigated in past literature, but sufficient API release into human milk had not been achieved. The presented work illustrates the delivery of iron sulphate pentahydrate from liquid-core sodium alginate hydrogels, inserted into a commercially available ultra-thin silicone nipple shield into human milk during in-vitro breastfeeding simulation. Release of iron was quantified employing absorbance measurements of a salicylic assay. An absolute recovery of 44.35 ± 5.43% of loaded iron(III)sulphate pentahydrate was obtained after 10.58 ± 0.09 g of human milk had passed through the nipple shield. This finding is superior to previous investigations involving the delivery of zinc from rapidly disintegrating tablets and non-woven fibres within a TNS. Due to their superior delivery properties, ease of fabrication and cost-efficiency, liquid-core sodium alginate hydrogels consequently represent a promising dosage form for use as part of the TNS. Further improvements can be made to enhance handling stability and shelf-life characteristics.
为了帮助婴儿进行口服治疗，先前开发了一种称为治疗奶嘴盾（TNS）的新型输送技术。它由硅酮奶嘴盾装置和含有治疗剂（或活性药物成分（API））的剂型组成，以在母乳喂养期间进行输送。过去的文献中研究了多种剂型，但尚未实现足够的 API 释放到母乳中。本工作说明了将五水合硫酸亚铁从插入到市售超薄硅酮奶嘴盾中的液体芯海藻酸钠水凝胶递送到人乳中，在体外母乳喂养模拟期间。使用水杨酸测定法的吸光度测量来定量铁的释放。通过奶嘴盾穿过 10.58±0.09g 人乳后，获得了负载的三价铁（III）五水合硫酸铁的绝对回收率 44.35±5.43％。这一发现优于先前涉及 TNS 内快速崩解片和无纺纤维中锌输送的研究。由于其优越的输送性能，易于制造和成本效益，因此液体芯海藻酸钠水凝胶因此成为用作 TNS 一部分的有前途的剂型。可以进行进一步的改进以增强处理稳定性和保质期特性。
