Rapid reconstitution packages (RRPs) for stable storage and delivery of glucagon
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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.
KeywordsReconstitution Hypoglycemia Glucagon Microfluidics Computational fluid dynamics (CFD) Stability Drug delivery Diabetes Emergency medicine Ambulatory settings
This research work was partially supported by GearJump Technologies, LLC, and the US Army Research Office via the Institute for Soldier Nanotechnologies (ISN) at the Massachusetts Institute of Technology (MIT), contract: W911NF-07-D-0004. The corresponding author’s former affiliation was the Institute for Soldier Nanotechnologies (ISN) at MIT.
Compliance with ethical standards
Conflict of interest
N. M. Elman works at GearJump Technologies, LLC. S. D’hers, A. N. Abad Vazquez, and P. Gurman declare that they have no conflict of interest.
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