Department of Mechanical Engineering, Instituto Tecnológico de Buenos Aires (ITBA), Ave. Madero 399, A-1-2, CP 1106, Buenos Aires, Argentina.
GearJump Technologies, LLC, PO Box 1600, Brookline, MA, 02446, USA.
Drug Deliv Transl Res. 2019 Jun;9(3):631-640. doi: 10.1007/s13346-019-00615-4.
Current emergency injectors of glucagon require manual reconstitution, which involves several steps that may lead to dosage errors. Rapid reconstitution packages (RRPs) are new devices, designed using computational fluid dynamics (CFD) to optimize fluid mixing, integrating physical properties of active pharmaceutical ingredients (APIs), excipients and diluents. RRPs improve drug stability for long-term storage and ease of delivery. Device prototypes were manufactured using advanced stereolithography apparatus (SLA) 3D printing technology. Reconstitution of glucagon with RRPs was evaluated by high-performance liquid chromatography (HPLC) and optical spectroscopy methods. Enzyme-linked immunosorbent assays were performed to test in vitro activity. Experimental results showed that RRPs effectively reconstituted glucagon even after exposure to 60 °C for a 24-h period. RRPs exhibited improved performance at maintaining drug stability compared to lyophilized glucagon stored in a standard glass vial under the same temperature conditions. RRPs represent a portable platform for rapid reconstitution of lyophilized drugs, compatible with standard syringes available in any clinical setting. The RRP provides an alternative to manual reconstitution process, especially designed for medical emergencies.
目前的胰高血糖素紧急注射器需要手动复溶，这涉及到几个步骤，可能导致剂量错误。快速复溶包（RRP）是新的设备，使用计算流体动力学（CFD）设计，以优化流体混合，整合原料药（API）、赋形剂和稀释剂的物理性质。RRP 提高了药物的长期储存稳定性，并便于输送。使用先进的立体光刻（SLA）3D 打印技术制造了设备原型。通过高效液相色谱（HPLC）和光学光谱方法评估 RRPs 对胰高血糖素的复溶效果。通过酶联免疫吸附测定法（ELISA）进行体外活性测试。实验结果表明，RRP 即使在 60°C 下暴露 24 小时后，也能有效地复溶胰高血糖素。与在相同温度条件下储存在标准玻璃小瓶中的冻干胰高血糖素相比，RRP 在维持药物稳定性方面表现出了更好的性能。RRP 代表了一种用于快速复溶冻干药物的便携平台，与任何临床环境中都可获得的标准注射器兼容。RRP 提供了一种替代手动复溶过程的方法，特别是为医疗紧急情况设计的。
