Portable electronically controlled transdermal patch for enfuvirtide delivery

描述（由申请人提供）：在NIH SBIR二期研究中，压电共振创新公司将进一步优化和测试便携式透皮贴片（PTP）——一种用于目前皮下递送的药物和疫苗的无针平台递送技术。这款便携式、200克（7盎司）的电子控制透皮贴片用于给药，采用专利传感器技术，集成电池驱动控制，按规定给药。低功率的PTP换能器将在角质层中打开25至125 5m的微通道，而不会造成长期的皮肤损伤。全世界有3300万人感染了人类免疫缺陷病毒（HIV）。目前，感染艾滋病毒的患者接受高效抗逆转录病毒治疗（HAART）来控制感染。治疗艾滋病毒的药物方案必须近乎完美地遵守，以最大限度地提高疗效并防止病毒耐药性的发展。Enfuvirtide于2003年获得美国食品和药物管理局批准，是一种输液抑制剂，可以阻止HIV病毒附着在CD4细胞上。它每天皮下注射两次，用于对其他治疗无效的患者。主要的副作用是注射部位反应，这大大降低了患者的依从性。一种可以提高患者对恩福韦肽和其他大分子药物（如胰岛素）依从性的无针装置将大有裨益。第一阶段开发和测试了原型，并满足了所有的具体目标。恩富韦肽在猪皮肤模型中经皮给药。实践临床医生的评价是积极的，并已用于指导II期Beta原型设计要求。第二阶段将优化PTP的性能特征和电子控制，使其成为一个小而轻、符合人体工程学的贴片。PTP的安全性和有效性将在活体动物模型中进行评估。PTP透皮给药技术将：“经皮给药恩富维肽（T-20），提高患者用药依从性”，消除限制T-20采用的注射部位反应，“作为平台技术，给药其他大分子药物（如胰岛素）”，“穿着舒适，手术时无痛，隐藏在衣服里。”通过处方储存库提供药物，储存库可以储存数天的剂量。”提供低剂量，持续给药-而不是大剂量。

DESCRIPTION (provided by applicant): In this Phase II NIH SBIR, Piezo Resonance Innovations will further optimize and test the Portable Transdermal Patch (PTP) - a needle-free platform delivery technology for drugs and vaccines that are currently delivered subcutaneously. The portable, 200gm (7oz) electronically-controlled transdermal patch for Enfuvirtide delivery employs a patented transducer technology with integrated battery driven controls to deliver drugs as prescribed. The low power of the PTP transducers will open 25 to 125 5m micro-channels in the stratum corneum, without causing long-term skin damage. Thirty-three million people worldwide are living with the Human Immunodeficiency Virus (HIV). Currently, patients infected with HIV receive Highly Active Antiretroviral Therapy (HAART) for the management of the infection. Medication regimens for the management of HIV must be taken with near-perfect compliance to maximize benefits and prevent development of viral resistance. Enfuvirtide, approved by the Food and Drug Administration in 2003, is an infusion inhibitor that blocks the HIV from attaching to the CD4 cell. It is subcutaneously injected twice daily and directed at patients not responding to other treatments. The major side effect is an injection site reaction, which reduces patient compliance substantially. A needle-free device that enhances patient compliance with Enfuvirtide, and other large-molecule medication regimes, like insulin, will be of great benefit. Phase I developed and tested prototypes and met all of the Specific Aims. Transdermal delivery of Enfuvirtide was demonstrated in pig skin models. Reviews by practicing clinicians were positive and have been used to guide the Phase II Beta prototype design requirements. Phase II will optimize the PTP performance characteristics and electronic control into a small lightweight, ergonomic patch. Safety and efficacy of the PTP will then be evaluated in a live animal model. The PTP Transdermal Delivery Technology will: " Deliver Enfuvirtide (T-20) Transdermally, increasing patient regime compliance " Eliminate the injection site reaction that limits T-20 adoption " Act as a platform technology to deliver other large molecule medications (e.g. insulin) " Be comfortable to wear, painless during operation, and hide discretely under clothing. " Deliver medications through a prescription reservoir that holds dosing for multiple days. " Deliver lower dose, sustained delivery - rather than large bolus dosage.