772-P: Portability of Nasal Glucagon for the Rescue of Severe Hypoglycemia: Stability and Performance Evaluation across a Broad Range of Temperatures

Autor: Ross Allen, Brian W. Pack, Jason Melnick, Christopher Breen
Rok vydání: 2021
Předmět:
Zdroj: Diabetes. 70
ISSN: 1939-327X
0012-1797
Popis: Background and Aims: Nasal glucagon is a ready-to-use, drug-device combination therapy for the treatment of severe hypoglycemia. Portability is key, as nasal glucagon should be carried by persons with diabetes at all times. In designing for portability, the medication must allow for exposure to a broad range of temperatures without significant adverse effect on product quality/performance. In this study, we evaluated the stability and performance of nasal glucagon at temperatures ranging from -20 to +30 °C (-4 to +86 °F) in order to mimic real world situations. Methods: Testing focused on characterization of drug product (glucagon amount) and combination product performance (consistent delivery to nasal cavity). Critical quality elements, including chemical purity and content, particle size, actuation force, delivered dose, shot weight, spray pattern and plume geometry, were evaluated after being exposed to temperatures from -20 and +30 °C, a range broader than a typically controlled room temperature product [i.e., Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F)], such as glucagon for injection. Results: All testing demonstrated that 100% of critical quality elements were satisfied. Nasal glucagon could be exposed to frozen (-20 °C), refrigerated (2 to 8°C), and up to 30 °C conditions for the 2-year shelf life. The degradation of glucagon followed Arrhenius kinetics (i.e., slower degradation rates at lower temperatures). Temperature cycling studies showed no significant changes in the chemical/product performance attributes. Conclusions: These analyses indicate no adverse impact to nasal glucagon from the chemical and physical perspective when exposed to frozen, refrigerated, and up to 30 °C conditions. The stability across a broad range of temperatures facilitates the portability of nasal glucagon as a rescue medication for severe hypoglycemia. Disclosure B. W. Pack: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. J. Melnick: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Eli Lilly and Company. C. Breen: Employee; Self; Eli Lilly and Company. R. Allen: Employee; Self; Eli Lilly and Company. Funding Eli Lilly and Company
Databáze: OpenAIRE
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