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

开发用于小动物行为研究的植入式按需给药装置

• 批准号: 9407379
• 负责人: Forrest Payne
• 金额: $ 75.01万
• 依托单位: SFC FLUIDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9407379
• 关键词: Address; Animal Experimentation; Animals; Behavioral; Blood; Canis familiaris; Communication; Development; Devices; Drug Addiction; Drug Delivery Systems; Drug Kinetics; Drug usage; Evaluation; Funding; Goals; Government; Hand; Hospitals; Implant; Injection of therapeutic agent; Instruction; International; Intravenous Bolus; Investments; Journals; Liquid substance; Marketing; Medical; Miniaturization; Modeling; Naloxone; Naltrexone; Names; National Institute of Drug Abuse; North Carolina; Opiates; Opioid; Oral; Overdose; Peer Review; Persons; Phase; Preclinical Drug Development; Protocols documentation; Publications; Publishing; Pump; Rattus; Research; Rewards; Sales; Self Administration; Sterilization; System; Technology; Testing; Therapeutic; Time; Universities; Veterinary Medicine; Wireless Technology; addiction; base; behavioral study; comparative efficacy; cost; design; drug development; implantation; improved; in vivo; manufacturing process; miniaturize; model development; novel; pre-clinical; preclinical development; programs; research and development; social; social stress; subcutaneous; symposium; tool

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.

植入式按需给药系统的研制 用于小动物行为研究的装置 项目总结： 这一第二阶段项目的具体目标是最终确定矿场的发展-- EPumpTM，一种低成本、电池供电、无线控制、按需或可编程的药物 给药系统，并确定其在改善药物成瘾和药物开发方面的用途 模特们。在第一年，MinePump将进行优化，以实现可靠的植入和 在小到老鼠的动物身上穿着很舒服。在第二阶段的后半部分，该泵将 进行广泛的测试，以验证这项使能技术用于药物成瘾研究，在 临床前药物开发研究和兽医治疗药物的交付。 第二阶段结束时，将看到MIN的制造和运行参数的定义 EPump和研究成果的出版。以下目标将使我们能够完成 二期工程： 目标1-将Mini-ePump微型化并进行优化，以在 在大鼠模型上植入。 目的2-比较Mini-ePump与传统系留泵在自体心脏手术中的疗效。 一种植入物的药物成瘾研究和社会行为效应测试 注入一只大鼠模型。 目标3-在使用药物成瘾的PK/PD研究中使用min-ePump的效果 在大鼠模型上具有治疗作用。 目的4-使用犬模型显示min-ePump在兽医中的应用效果。 目标5-最终确定Mini-ePump的设计，以最好地满足每个目标的需求 细分市场并定义制造流程。 该项目将解决NIDA确定的两个迫切需要的技术差距。在.之下 最初的第一阶段征集，该项目直接针对以下特定需求主题 “开发成瘾的临床前模型。”Min-ePump也适用于 NIDA于2015年1月发布了临床前药物开发的计划优先事项 使技术成为可能。