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

描述（由申请人提供）：确保针对生物恐怖分子或自然发生的病原体的大规模运动的成功，需要储存疫苗、治疗剂和其他产品，并在发现对公共健康的威胁时立即使用。在这些情况下，储存是管理成本的主要贡献者，并且保持活性产品冷藏的要求可使成本增加三倍或更多。还普遍接受的是，单剂量递送系统在疾病传播和微生物污染方面提供额外的益处。这些和其他问题通过Immunoject解决，Immunoject是一种新的平台装置，其应用于现在可以配制为快速溶解粉末的许多药物产品的肠胃外递送。单位剂量自动重构装置是紧凑的、相对平坦的，并且呈现出经济上有吸引力的存储轮廓。它由一个整体密封的无菌薄膜袋组成，其中两个隔室由易碎膜隔开，以及由模制塑料部件制成的给药装置。小袋的一个隔室的尺寸被设定为容纳预定体积的注射用水，而另一个隔室容纳配制为快速溶解且热稳定的粉末的药物化合物的剂量。在四个用户友好的步骤中，医护人员将拇指压力施加到水室，这反过来又导致活性粉末溶解，然后通过针头向患者施用。该项目的总体目标是通过证明该设备将保持其功能和储存在其粉末室中的无硫柳汞乙型肝炎疫苗的热稳定性，加速Immunoject的商业化道路。这将通过实现三个具体目标来实现。第一种方法将疫苗配制成快速溶解的纳米和微米级粉末，并完成检测，以验证HBsAg抗原仍然与明矾佐剂结合，并且粉末保留了疫苗的原始效力。第二个目的是确保粉末在48小时内没有吸收统计学上显著的水分，并测试Immunoject的功能和性能。最后，第三个目标是评估粉末和填充的Immunoject设备在-20 ℃至65 ℃的温度下的稳定性，储存期为一周到十二个月。 公共卫生相关性：该项目旨在加速Immunoject，一种新的单位剂量，用于胃肠外输送的自动重建装置，走向商业化。这种新装置将大大降低储存和向生物恐怖分子或自然发生的病原体传播引起的大规模公共卫生运动的受试者施用预防或治疗剂量的成本。Immunoject潜力的关键是活性成分的创新配方，如热稳定和快速溶解的干粉。

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.