JZUS - Journal of Zhejiang University SCIENCE

Journal of Zhejiang University SCIENCE B

Accepted manuscript available online (unedited version)

Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment

Author(s): Chun-yu Li^1;2, Zhe-wei Wang^2;5, Can Tu^2;6, Jia-bo Wang², Bing-qian Jiang², Qi Li^2;3, Ling-na Zeng², Zhi-jie Ma³, Ping Zhang⁴, Yan-ling Zhao², Ya-ming Zhang², Dan Yan², Rui Tan⁵, Xiao-he Xiao⁴
Affiliation(s): 1. School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China;2. China Military Institute of Chinese Medicine, 302 Military Hospital, Beijing 100039, China;3. Department of Traditional Chinese Medicine, Beijing Friendship Hospital of Capital Medical University, Beijing 100050, China;4. Integrative Medicine Center, 302 Military Hospital, Beijing 100039, China;5. School of Life Science and Engineering, Southwest Jiaotong University, Chengdu 610031, China;6. School of Pharmacy, Hunan University of Traditional Chinese Medicine, Changsha 410208, China
Corresponding email(s): pharm_sci@126.com
Key Words: Powder needleless injection, Insulin, Transdermal drug delivery, Skin irritation

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Chun-yu Li, Zhe-wei Wang, Can Tu, Jia-bo Wang, Bing-qian Jiang, Qi Li, Ling-na Zeng, Zhi-jie Ma, Ping Zhang, Yan-ling Zhao, Ya-ming Zhang, Dan Yan, Rui Tan, Xiao-he Xiao. Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment[J]. Journal of Zhejiang University Science B,in press.Frontiers of Information Technology & Electronic Engineering,in press.https://doi.org/10.1631/jzus.B1400065

@article{title="Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment",
author="Chun-yu Li, Zhe-wei Wang, Can Tu, Jia-bo Wang, Bing-qian Jiang, Qi Li, Ling-na Zeng, Zhi-jie Ma, Ping Zhang, Yan-ling Zhao, Ya-ming Zhang, Dan Yan, Rui Tan, Xiao-he Xiao",
journal="Journal of Zhejiang University Science B",
year="in press",
publisher="Zhejiang University Press & Springer",
doi="https://doi.org/10.1631/jzus.B1400065"
}

%0 Journal Article
%T Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment
%A Chun-yu Li
%A Zhe-wei Wang
%A Can Tu
%A Jia-bo Wang
%A Bing-qian Jiang
%A Qi Li
%A Ling-na Zeng
%A Zhi-jie Ma
%A Ping Zhang
%A Yan-ling Zhao
%A Ya-ming Zhang
%A Dan Yan
%A Rui Tan
%A Xiao-he Xiao
%J Journal of Zhejiang University SCIENCE B
%P 888-899
%@ 1673-1581
%D in press
%I Zhejiang University Press & Springer
doi="https://doi.org/10.1631/jzus.B1400065"

TY - JOUR
T1 - Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment
A1 - Chun-yu Li
A1 - Zhe-wei Wang
A1 - Can Tu
A1 - Jia-bo Wang
A1 - Bing-qian Jiang
A1 - Qi Li
A1 - Ling-na Zeng
A1 - Zhi-jie Ma
A1 - Ping Zhang
A1 - Yan-ling Zhao
A1 - Ya-ming Zhang
A1 - Dan Yan
A1 - Rui Tan
A1 - Xiao-he Xiao
J0 - Journal of Zhejiang University Science B
SP - 888
EP - 899
%@ 1673-1581
Y1 - in press
PB - Zhejiang University Press & Springer
ER -
doi="https://doi.org/10.1631/jzus.B1400065"

Abstract
Chinese Summary
Academic Network
Reviewer Comment

Abstract: insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection (PNI) device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors (gas pressure, cylinder volume, and nozzle distance) were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.

胰岛素粉末无针注射的给药效率和皮肤刺激性评价

研究目的：胰岛素在临床上广泛用于糖尿病的治疗，但需要注射方式给药，给患者带来不便。本文报道了一种胰岛素粉末无针注射给药的新方法，并对其给药效率和皮肤刺激性进行评价。
创新要点：首次报道了胰岛素粉末无针注射给药方法，有望为糖尿病患者长期自我给药提供便捷。
研究方法：自主设计便携式自动无针粉末注射给药装置，采用计算机辅助方法计算给药装置的主要空气动力学参数；采用家兔评价无针粉末注射对皮肤的刺激性，并分析与空气动力学参数的相关性；采用四氧嘧啶诱导家兔糖尿病模型，评价不同无机盐载药的胰岛素粉末的无针注射给药降糖效果。
重要结论：采用自主设计便携式自动无针粉末注射给药装置，递送以无机盐为载体的胰岛素粉末具有显著的降血糖作用，而递送胰岛素原料药粉末无降血糖作用，说明无机盐载体对胰岛素粉末无针注射给药效果具有重要作用。皮肤刺激性实验表明，储气室气压、容积以及喷管与皮肤的间距三个参数显著影响无针粉末注射装置的皮肤损伤程度，优化后的注射条件对皮肤几乎没有损伤。优化给药条件下以磷酸盐载体的胰岛素粉末无针注射给药，相对给药效率为72.25%。研究结果表明无针粉末注射技术用于胰岛素或其它生物制品的无针给药具有良好应用前景。
无针粉末注射；胰岛素；经皮给药；皮肤刺激性

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胰岛素粉末无针注射的给药效率和皮肤刺激性评价

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References