FIELD: biotechnology.
SUBSTANCE: invention relates to stabilization of glucagon analogues in pharmaceutical formulations and can be used in medicine in treating hypoglycaemia. Disclosed are stable liquid aqueous pharmaceutical formulations for controlling blood glucose levels containing a glucagon analogue Hy-HSQGTFTSDYSKYLD-Aib-ARAEEFVKWLEST-OH or its pharmaceutically acceptable salt and a combination of excipients. TRIS, ACES and MES buffers and/or acetate, citrate or succinate buffers provide chemical stability of said glucagon analogue compositions at weakly acidic or neutral pH. Comparative analysis of degradation profiles has shown that these buffers provide higher stability compared to other tested buffer systems, such as histidine or phosphate, even if the compositions have the same pH, that is, the stability provided by the buffers is at least partially independent of their pH-modulating properties.
EFFECT: invention provides long-term stability of dasiglucagon in liquid form.
17 cl, 21 tbl, 2 ex
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Authors
Dates
2024-05-28—Published
2021-03-16—Filed