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J Diabetes Sci Technol. 2015 Jan;9(1):24-33. doi: 10.1177/1932296814565131.

Development of a highly stable, nonaqueous glucagon formulation for delivery via infusion pump systems.

Author information

1
Xeris Pharmaceuticals, Inc, Austin, TX, USA.
2
Legacy Health and Legacy Research Institute, Portland, OR, USA Pacific Diabetes Technologies, Portland, OR, USA.
3
Oregon Health & Science University, Portland, OR, USA.
4
Insulet Corporation, Billerica, MA, USA.
5
Xeris Pharmaceuticals, Inc, Austin, TX, USA stevep@xerispharma.com.

Abstract

Despite a vigorous research effort, to date, the development of systems that achieve glucagon stability in aqueous formulations (without reconstitution) has failed to produce any clinical candidates. We have developed a novel, nonaqueous glucagon formulation based on a biocompatible pharmaceutical solvent, dimethyl sulfoxide, which demonstrates excellent physical and chemical stability at relatively high concentrations and at high temperatures. This article reports the development of a novel, biocompatible, nonaqueous native human glucagon formulation for potential use in subcutaneous infusion pump systems. Data are presented that demonstrate physical and chemical stability under presumed storage conditions (>2 years at room temperature) as well as "in use" stability and compatibility in an Insulet's OmniPod(®) infusion pump. Also presented are results of a skin irritation study in a rabbit model and pharmacokinetics/pharmacodynamics data following pump administration of glucagon in a diabetic swine model. This nonaqueous glucagon formulation is suitable for further clinical development in pump systems.

KEYWORDS:

glucagon; hypoglycemia; infusion; nonaqueous

PMID:
25550410
PMCID:
PMC4495537
DOI:
10.1177/1932296814565131
[Indexed for MEDLINE]
Free PMC Article

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