Stability and functionality of the Immunoject single-dose, auto-reconstitution de

Immunoject 单剂量、自动重构 de 的稳定性和功能性

• 批准号: 7925483
• 负责人: Brian Quinn
• 金额: $ 20万
• 依托单位: AKTIV-DRY, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-05 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7925483
• 关键词: Adjuvant; Antigens; Biological Assay; Devices; Dose; Drug Formulations; Equilibrium; Excipients; Film; Goals; Health Campaign; Health Personnel; Hepatitis B Surface Antigens; Hepatitis B Vaccines; Hour; Housing; Injection of therapeutic agent; Membrane; Molds; Needles; Patients; Performance; Permeability; Pharmacologic Substance; Plastics; Powder dose form; Process; Public Health; Rewards; Risk; System; Technology; Temperature; Testing; Therapeutic; Thimerosal; Thumb structure; Time; Vaccines; Water; aluminum sulfate; commercialization; cost; disease transmission; innovation; microbial; nano; pathogen; pressure; prophylactic; public health relevance; reconstitution; seal; success; therapeutic vaccine; transmission process; user-friendly

DESCRIPTION (provided by applicant): Assuring the success of mass campaigns against bioterrorist or naturally occurring pathogens requires that vaccines, therapeutics, and other products are stored and ready for immediate use at the time the threat to public health is perceived. Storage is a major contributor to the cost of administration under these circumstances and a requirement to keep the active product refrigerated can increase the cost by a factor of three, or more. It is also generally accepted that single dose delivery systems provide additional benefits in terms of disease transmission and microbial contamination. These and other issues are resolved by Immunoject, a new platform device with application to the parenteral delivery of the many pharmaceutical products that may now be formulated as rapidly dissolving powders. The unit-dose auto-reconstitution device is compact, relatively flat, and presents an economically attractive storage profile. It consists of an integrally sealed aseptic film pouch with two compartments separated by a frangible membrane, together with an administration device made from molded plastic parts. One compartment of the pouch is sized to hold a pre-determined volume of water for injection while the other compartment houses a dose of pharmaceutical compound formulated as a rapidly dissolving and thermally stable powder. In four user-friendly steps, a healthcare worker applies thumb pressure to the water compartment which, in turn, causes the active powder to dissolve and then to be administered through a needle to the patient. The overarching goal of this project is to accelerate Immunoject on its path to commercialization by demonstrating that the device will maintain its functionality and the thermal stability of thimerosal-free hepatitis-B vaccine stored within its powder compartment. This will be achieved by achieving three specific aims. The first of these formulates the vaccine as rapidly dissolving nano- and micro-scale powders and completes assays to verify that the HBsAg antigen remains bonded to the alum adjuvant, and that the powders retain the vaccine's original potency. The second aim assures that the powders have adsorbed no statistically significant moisture in 48 hours and tests the functionality and performance of the Immunoject. And finally, the third aim assesses the stability of powders and filled Immunoject devices at temperatures from -20 ¿C through 65 ¿C with storage periods from one week through twelve months. PUBLIC HEALTH RELEVANCE: This project seeks to accelerate Immunoject, a new unit-dose, auto-reconstitution device for parenteral delivery, on its path to commercialization. The new device will significantly reduce the costs of storing and administering a prophylactic or therapeutic dose to subjects of a mass public health campaign provoked by the transmission of a bioterrorist or naturally occurring pathogen. Key to Immunoject's potential is the innovative formulation of active ingredients as thermally stable and rapidly dissolving dry powders.

描述（由适用提供）：确保针对生物恐怖主义者或天然发生的病原体的大规模运动成功，要求疫苗，治疗和其他产品存储，并在认为对公共卫生的威胁时可以立即使用。在这种情况下，存储是管理管理成本的主要贡献者，保持活跃产品冷藏的要求可以将成本增加三倍或更多。同样普遍认为，单剂量输送系统在疾病传播和微生物污染方面提供了其他好处。这些问题和其他问题是通过Immunoject解决的，Immunoject是一种新的平台设备，该设备可用于父母交付许多药品，这些产品现在可以将其作为快速溶解的粉末配制。单位剂量自动恢复设备紧凑，相对平坦，并具有经济上有吸引力的存储曲线。它由一个整体密封的象征膜袋组成，两个隔室由一个易碎的膜分开，以及由模制塑料部件制成的管理装置。一个小袋的一个隔间尺寸的大小可容纳预先确定的水以进行注入，而另一个隔间则容纳了一剂，形成的药物剂量是快速溶解和热稳定的粉末。在四个用户友好的步骤中，医护人员向水室施加了拇指压力，这反过来又导致主动粉末溶解，然后通过针对患者进行施用。该项目的总体目标是通过证明该设备将保持其功能和无热丙型肝炎疫苗的热稳定性来加速其商业化的免疫照射。这将通过实现三个具体目标来实现。其中的第一个将疫苗制定为迅速溶解纳米和微尺度粉末，并完成阿萨斯以验证HBSAG抗原是否保持与校友调整保持粘合，并且粉末保留了疫苗的原始效力。第二个目的假设粉末在48小时内没有吸附统计上显着的水分，并测试了免疫投影的功能和性能。最后，第三个目标评估了粉末的稳定性，并在温度从-20€至65°C的温度下填充了免疫投影设备，储存周期为一周至十二个月。 公共卫生相关性：该项目试图在其商业化的道路上加速一种新的单位剂量，自动恢复的自动恢复设备。新设备将大大降低为大规模公共卫生运动的受试者的预防或治疗剂量储存和管理预防和治疗剂量的成本，这是通过传播生物疗法或自然发生的病原体证明的。免疫投资潜力的关键是活性成分的创新配方作为热稳定并迅速溶解的干粉末。