Noel M Elman
Massachusetts Institute of Technology, USA
Title: Rapid reconstitution packages (rrps) for emergency delivery of glucagon: Hypoglycemia treatment in type 1 diabetes (T1D)
Biography
Biography: Noel M Elman
Abstract
Hypoglycemia is a condition characterized by abnormally low blood glucose (e.g., blood sugar) levels. Glucagon is an effective therapy for severe hypoglycemia however it is reported to be unstable in liquid form. Therefore, smart technological platforms must be engineering to keep its activity and efficacy during an effective and safe hypoglycemia treatment in emergency conditions. Rapid Reconstitution Packages (RRPs) are handy technologies based on microfluidics platforms for rapid reconstitution of lyophilized biopharmaceutical drugs than can be used in time- critical therapies. RRPs were fabricated using computational simulation such as Computational Fluid Dynamics (CFD) that allows for an analytical methodology to maximize fluidic components for mixing, integrating both physical and chemical properties of targeted active ingredients and solvents. Devices were fabricated using 3D printing technology for micrometer structural precision and rapid prototyping. Glucagon was used due its instability and special features as the drug standard to evaluate the new RRPs generation. Current forms of glucagon cannot be kept for long periods of time due its unstable in aqueous solutions. Glucagon is a polypeptide hormone produced by alpha-cell of the pancreatic islet to increases blood glucose levels and relaxes smooth muscle of the gastrointestinal tract. This hormone was stored in lyophilized and aqueous form into the RRPs. Glucagon is essential in the treatment of severe hypoglycemia for which its rapid reconstitution is of supreme importance. RRPs efficiency and hormone stability were evaluated by HPLC to characterize glucagon release kinetics. Spectroscopy methods are also used. Hormone activity was monitored by Enzyme-Linked Immunosorbent Assays (ELISAs) exposing RRPs to various controlled temperature conditions. Experimental results showed that RRPs provide an effective reconstitution of glucagon and that its release kinetics is strongly correlated with computational modeling. The design and fabrication of RRPs can be adapted for others therapeutics applications by taking into account critical key point parameters (e.g., chemical and physical) to maximize efficiency, efficacy, reconstitution and controlled release kinetics of the active ingredients.