Fabrication and Characterization of Dissolvable Microneedle Arrays for Effective

可溶性微针阵列的制备和表征，以实现有效的

• 批准号: 8320919
• 负责人: Louis D Falo
• 金额: $ 40.99万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8320919
• 关键词: Address; Adjuvant; Antigens; Biology; Characteristics; Clinical; Clinical Trials; Complex; Coupled; Cutaneous; Data; Dermatology; Dermis; Development; Devices; Drug Delivery Systems; Economics; Effectiveness; Encapsulated; Engineering; Epidermis; Failure; Goals; Human; Immunization; Immunization Programs; In Vitro; Knowledge; Laboratories; Lead; Life; Mechanics; Mediating; Methods; Modeling; Molds; Needles; Oral; Patients; Penetration; Positioning Attribute; Prevention; Process; Property; Publishing; Reproducibility; Research Design; Research Personnel; Skin; Speed; Stretching; Techniques; Technology; Temperature; Testing; Therapeutic Agents; Time; Translations; Vaccines; Variant; base; clinically relevant; design; experience; human disease; immunogenicity; in vivo; novel; prevent; public health relevance; therapeutic vaccine; viscoelasticity

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.

描述（由申请人提供）：使用基于微针阵列（MNA）的装置进行生物制剂的透皮递送，与流行的口服和基于针的药物递送方法相比，具有有吸引力的理论优势。然而，设计、制造和测试方面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基于可溶性微针阵列的皮肤递送平台，能够高效、精确且可重复地将生物活性分子递送至人体皮肤。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，该平台可直接适用于患者友好的临床递送多种治疗剂。我们组建了一支多学科研究团队，在机械工程、皮肤生物学和皮肤病学方面拥有广泛且直接相关的经验。我们共同开发了新颖且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 药物输送有效性和可重复性的微针和阵列配置的几何和机械特性。这一新知识将应用于 MNA 的设计和制造，其物理特性与有效的皮内药物输送相兼容。 公共卫生相关性：使用基于微针阵列 (MNA) 的设备透皮递送生物制剂比流行的口服和针头药物递送方法具有有吸引力的理论优势。然而，设计、制造和测试方面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基于可溶性微针阵列的皮肤递送平台，能够高效、精确且可重复地将生物活性分子递送至人体皮肤。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，该平台可直接适用于患者友好的临床递送多种治疗剂。