Phase‐Transition Microneedle Patches for Efficient and Accurate Transdermal Delivery of Insulin,Advanced Functional Materials

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Phase‐Transition Microneedle Patches for Efficient and Accurate Transdermal Delivery of Insulin
Advanced Functional Materials ( IF 18.5 ) Pub Date : 2015-06-18 , DOI: 10.1002/adfm.201500554
Sixing Yang ₁ , Fei Wu ₁ , Jianguo Liu ₂ , Guorong Fan ₂ , William Welsh ₃ , Hua Zhu ₄ , Tuo Jin ₁

Affiliation

Utilizing the unique virtue of polyvinyl alcohol (PVA) of forming microcrystalline domains as the cross‐linking junctions, a new microneedle system, phase‐transition microneedle (PTM) patch, is invented, which enables highly efficient transdermal delivery of insulin without depositing the needle tip materials to the skin. PTM, formed of biocompatible PVA as the main component, is sufficiently strong for its needle tip to penetrate the epidermis in the dry state, release preloaded cargos by absorbing body fluid in the dermis layer nearly as fast as subcutaneous injection, and retain mechanical toughness in the hydrated state to ensure complete removal from the skin. The microcrystalline cross‐linking enables a protein‐friendly fabrication process free of hazardous cross‐linking agents required for chemical and ionic cross‐linking. Pharmacokinetic and efficacy studies of insulin‐loaded PTM using pig models indicate a transdermal bioavailability over 20%, similar deviations and peak width, only 18 min behind Tmax, and lower glycated hemoglobin (HbA_1c) as compared with injection pens. The complete removability of hydrated needle tips may endow PTM with an additional safety insurance, terminating medication whenever hypoglycemia becomes a concern. PTM patch is practically applicable to a variety of protein/peptide medicines requiring frequent dosing by offering painless administration, freedom of refrigeration, and minimal safety concerns.

中文翻译：

相变微针贴片可实现胰岛素的高效，透皮递送

利用聚乙烯醇（PVA）形成微晶结构域作为交联结的独特优势，发明了一种新的微针系统，即相变微针（PTM）贴剂，可实现胰岛素的高效透皮递送而无需沉积针头尖端材料到皮肤。以生物相容性PVA为主要成分的PTM具有足够的强度，足以使其针尖在干燥状态下穿透表皮，通过吸收真皮层中的体液释放皮下注射的速度几乎与皮下注射一样快，并保留了机械韧性。处于水合状态，以确保完全从皮肤上去除。微晶交联可实现蛋白质友好的制造工艺，而不含化学和离子交联所需的有害交联剂。_1c）与注射笔相比。水合针尖的完全可移动性可为PTM提供额外的安全保障，一旦出现低血糖问题，就终止用药。PTM贴片通过无痛给药，冷藏自由和最小的安全隐患，实际上可用于需要频繁给药的各种蛋白质/肽类药物。

更新日期：2015-06-18

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