US 12,343,383 B2
High concentration insulin formulation
Jeppe Sturis, Vaerloese (DK); Svend Havelund, Bagsvaerd (DK); and Karen-Margrethe Pedersen, Copenhagen V (DK)
Assigned to Novo Nordisk A/S, Bagsvaerd (DK)
Appl. No. 17/626,025
Filed by Novo Nordisk A/S, Bagsvaerd (DK)
PCT Filed Jul. 10, 2020, PCT No. PCT/EP2020/069512
§ 371(c)(1), (2) Date Jan. 10, 2022,
PCT Pub. No. WO2021/009027, PCT Pub. Date Jan. 21, 2021.
Claims priority of application No. 19185958 (EP), filed on Jul. 12, 2019.
Prior Publication US 2022/0249619 A1, Aug. 11, 2022
Int. Cl. A61K 38/00 (2006.01); A61K 9/00 (2006.01); A61K 31/7084 (2006.01); A61K 33/30 (2006.01); A61K 38/28 (2006.01); A61K 47/02 (2006.01); A61K 47/18 (2017.01); A61P 3/10 (2006.01)
CPC A61K 38/28 (2013.01) [A61K 9/0019 (2013.01); A61K 31/7084 (2013.01); A61K 33/30 (2013.01); A61K 47/02 (2013.01); A61K 47/18 (2013.01); A61P 3/10 (2018.01)] 20 Claims
 
1. A soluble insulin preparation comprising:
NϵB29-hexadecandioyl-γ-Glu-(desB30) human insulin in a concentration from 1800 nmol/ml to 4200 nmol/ml,
Zinc ions in a concentration from 4.0 Zn/6Ins to 7.0 Zn/6Ins,
Niacinamide in a concentration from 110 mM to 220 mM or treprostinil in a concentration from 0.02 μg/ml to 1 μg/ml,
Citrate in a concentration from 6 mM to 40 mM, and
pH in the range from 7.0 to 8.0.