Fabrication and Characterization of Dissolvable Microneedle Arrays for Effective

描述（由申请人提供）：使用基于微针阵列（MNA）的设备进行生物制剂的透皮给药，与目前流行的口服和针头给药方法相比，具有诱人的理论优势。然而，在设计、制造和测试方面的相当大的实际限制阻碍了临床相关阵列设计的发现。该项目的目标是合理设计一种基于可溶解微针阵列的皮肤递送平台，使生物活性分子能够高效、精确和可重复地递送到人体皮肤。重要的是，我们建议通过微针阵列递送平台来实现这一目标，该平台直接适用于患者友好型，广泛的治疗药物的临床递送。我们已经组建了一支多学科的研究团队，他们在机械工程、皮肤生物学和皮肤病学方面具有广泛和直接相关的经验。我们共同开发了新颖而全面的基于微铣削的制造技术，使我们能够实现这一目标。通过本文提出的研究，我们将确定影响MNA药物递送有效性和可重复性的微针和阵列配置的几何和力学特性。这一新知识将应用于设计和制造具有与有效皮内给药相容的物理特性的MNAs。

DESCRIPTION (provided by applicant): Transdermal delivery of biologics using microneedle-array (MNA) based devices offers attractive theoretical advantages over prevailing oral and needle-based drug delivery methods. However, considerable practical limitations in design, fabrication, and testing are preventing the discovery of clinically relevant array designs. The goal of this project is to rationally design a cutaneous delivery platform based on a dissolvable microneedle array that enables efficient, precise, and reproducible delivery of biologically active molecules to human skin. Importantly, we propose to accomplish this with a microneedle array delivery platform that is directly applicable to patient-friendly, clinical delivery of a broad range of therapeutic agents. We have assembled a multi-disciplinary team of investigators with broad and directly relevant experience in mechanical engineering, cutaneous biology, and dermatology. Together we have developed novel and comprehensive micro-milling based fabrication technologies that uniquely position us to accomplish this goal. Through studies proposed here, we will identify geometric and mechanical properties of microneedle and array configurations that impact the effectiveness and reproducibility of MNA drug delivery. This new knowledge will be applied to the design and fabrication of MNAs with physical characteristics compatible with effective intracutaneous drug delivery. PUBLIC HEALTH RELEVANCE: Transdermal delivery of biologics using microneedle-array (MNA) based devices offers attractive theoretical advantages over prevailing oral and needle-based drug delivery methods. However, considerable practical limitations in design, fabrication, and testing are preventing the discovery of clinically relevant array designs. The goal of this project is to rationally design a cutaneous delivery platform based on a dissolvable microneedle array that enables efficient, precise, and reproducible delivery of biologically active molecules to human skin. Importantly, we propose to accomplish this with a microneedle array delivery platform that is directly applicable to patient-friendly, clinical delivery of a broad range of therapeutic agents.