Development of an Implantable On-Demand Drug Delivery Device for Behavioral Studies in Small Animals

植入式按需给药系统的研制 小动物行为研究装置 项目摘要： 第二阶段项目的具体目标是完成最小- ePumpTM，一种低成本、电池供电、无线控制、按需或可编程的药物 递送系统，并确定其在改善药物成瘾和药物开发中的用途 模型在第1年，min-ePump将进行优化，以实现可靠的植入， 像老鼠一样小的动物身上的舒适穿着。在第二阶段的下半年，泵将 进行广泛的测试，以验证这种使能技术用于药物成瘾研究， 临床前药物开发研究和兽医学治疗药物的输送。 第二阶段结束时，将确定最小值的生产和操作参数。 ePump和研究成果的出版。以下目标将有助于完成 二期工程： 目标1 -微型化和优化min-ePump，以便于使用， 在大鼠模型中植入。 目的2 -比较min-ePump与传统栓系泵在自我治疗中的有效性 药物成瘾研究和测试植入药物的社会和行为影响 泵入大鼠模型。 目的3 -显示min-ePump在使用药物成瘾的PK/PD研究中的有效性 在大鼠模型中进行治疗。 目的4 -使用犬模型显示min-ePump在兽医学中的有效性。 目标5 -最终确定min-ePump的设计，以最大限度地满足每个目标的需求 市场细分和定义制造过程。 该项目将解决NIDA确定的两个高需求技术差距。下 最初的第一阶段招标，这个项目直接解决了一个特殊需要的主题， “开发成瘾的临床前模型。”Min-ePump也适用于 NIDA于2015年1月发布的临床前药物开发计划优先事项 使能技术。

Development of an Implantable On-Demand Drug Delivery Device for Behavioral Studies in Small Animals Project Summary: The Specific Aims of this Phase II project are to finalize the development of the min- ePumpTM, a low-cost, battery-operated, wirelessly controlled, on-demand or programmable drug delivery system, and to establish its use in improving drug addiction and drug development models. During Year 1, the min-ePump will be optimized for reliable implantation and comfortable wear in animals as small as a rat. During the second half of Phase II, the pump will be tested extensively to validate this enabling technology for use in drug addiction research, in pre-clinical drug development research and for delivery of therapeutics in veterinary medicine. The end of Phase II will see the definition of manufacturing and operating parameters for min- ePump and publication of research results. The following Objectives will allow for completion of the Phase II project: Objective 1 – Miniaturize and optimize min-ePump for ease-of-use and comfort during implantation in a rat model. Objective 2 – Compare efficacy of min-ePump to traditional tethered-pump in self- administration drug addiction research and test social and behavioral effects of an implanted pump in a rat model. Objective 3 – Show efficacy for use of min-ePump in PK/PD research using a drug addiction therapeutic in a rat model. Objective 4 – Show efficacy for use of min-ePump in veterinary medicine using a dog model. Objective 5 – Finalize the design of the min-ePump to best meet the needs of each target market segment and define the manufacturing process. This project will address two high need technology gaps identified by the NIDA. Under the original Phase I solicitation, this project directly addresses a special needs topic for “Development of pre-clinical models for addiction.” Min-ePump also applies to the programmatic priority released by NIDA in January of 2015 for preclinical drug development enabling technologies.