Journal of diabetes science and technology, 2014-10-28, Vol.9 (1), p.8-16
A promising approach to treat diabetes is the development of fully automated artificial/bionic pancreas systems that use both insulin and glucagon to maintain euglycemia. A physically and chemically stable liquid formulation of glucagon does not currently exist. Our goal is to develop a glucagon formulation that is stable as a clear and gel-free solution, free of fibrils and that has the requisite long-term shelf life for storage in the supply chain, short-term stability for at least 7 days at 37°C, and pump compatibility for use in a bihormonal pump.
We report the development of two distinct families of stable liquid glucagon formulations which utilize surfactant or surfactant-like excipients (LMPC and DDM) to “immobilize” the glucagon in solution potentially through the formation of micelles and prevention of interaction between glucagon molecules.
Data are presented that demonstrate long-term physical and chemical stability (~2 years) at 5°C, short-term stability (up to 1 month) under accelerated 37°C testing conditions, pump compatibility for up to 9 days, and adequate glucose responses in dogs and diabetic swine.
These stable glucagon formulations show utility and promise for further development in artificial pancreas systems.
Diabetes Mellitus, Experimental - drug therapy ; Drug Delivery Systems - instrumentation ; Drug Stability ; Humans ; Diabetes Mellitus, Type 1 - pathology ; Pharmaceutical Solutions - chemistry ; Glucagon - administration & dosage ; Male ; Diabetes Mellitus, Type 1 - drug therapy ; Animals ; Pharmaceutical Solutions - administration & dosage ; Swine ; Glucagon - chemistry ; Dogs ; Diabetes Mellitus, Experimental - pathology ; Female ; Drug Delivery Systems - methods ; Pancreas, Artificial ; Index Medicus
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