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Design and Administration of Dissolving Microneedle Patches In Human Subjects

机译:溶解人体溶解微针补丁的设计和施用

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Dissolving microneedle patches contain micron-sized needles made of water-soluble biodegradable polymers that dissolve in the skin to deliver encapsulated vaccine. They offer the simplicity of patch application and the possibility to mitigate the logistical and safety challenges associated with using conventional hypodermic needles. To ensure reliability in the dose being delivered, it is important to understand the biomechanics of the skin and the parameters that affect insertion and dissolution of microneedles into skin. We are studying these parameters in a human study with placebo dissolving microneedle patches (i.e., containing no vaccine) to prepare for a planned phase 1 clinical trial of influenza vaccination using microneedle patches of similar design.
机译:溶解微针贴片含有微米尺寸的针,由水溶性可生物降解的聚合物制成,其溶解在皮肤中以递送包封的疫苗。它们提供了补丁应用的简单性以及减轻与使用常规皮下注射针相关的物流和安全挑战的可能性。为了确保送达剂量的可靠性,重要的是要理解皮肤的生物力学以及影响微针溶解到皮肤中的插入和溶解的参数。我们正在使用安慰剂溶解微针贴片(即,不含疫苗)的人类研究中的这些参数来制备使用类似设计微针斑的植物疫苗疫苗的计划1临床试验。

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