Novel Automatic Dual Chamber Reconstitution Injectable Drug Delivery Device
Novel Automatic Dual Chamber Reconstitution Injectable Drug Delivery Device
批准号:
131244
负责人:
金额:
$5.86万
依托单位:
依托单位国家:
英国
项目类别:
Collaborative R&D
财政年份:
2013
资助国家:
英国
项目状态:
已结题
起止时间:
2013 至 --
中文摘要
大多数正在开发的新药都是可注射的大分子生物药物。它们在溶液中不稳定,需要重新配制或昂贵且往往不切实际的冷链物流。目前的重构装置是使用低效的工艺制造的,并且可能存在混合不良的问题。需要一种重构注射装置,该重构注射装置可靠且快速地重构并且可以使用更有效地制造的散装冻干粉末。传统的重构装置是复杂的,需要受过医学训练的人员来管理:家庭使用降低了管理成本。3P具有创新的设备概念:原型已经显示出初步的可行性。该项目将进一步开发该产品,重点是创新的混合和自动注射器功能。将获得粉末和液体混合效率的定量数据,并与当前标准工业双室注射器进行比较。
英文摘要
Most new pharmaceuticals under development are injectable large molecule biopharmaceuticals. Unstable in solution they require either reconstitution or costly and often impractical cold chain logistics. Current reconstitution devices are manufactured using an inefficient process and can suffer from poor mixing. There is a need for a reconstitution injection device which reliably and quickly reconstitutes and which can use more efficiently manufactured bulk lyophilised powder. Traditional reconstitution devices are complex requiring medically trained personnel to administer: home use lowers administration cost. 3P have an innovative device concept: prototypes have shown initial feasibility. The project will further develop the product with focus on the innovative mixing and auto-injector functionality. Quantitative data on the efficiency of mixing of the powder and liquid will be obtained and compared with a current standard industrial dual chamber syringe.
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