RU-2025135207-A - DISPERSED COMPOSITION CONTAINING ENSIFENTRINE

Inventors

• СПАРГО, Питер Лайонел
• ТЁРНЕР, Кевин Стивен

Assignees

• ВЕРОНА ФАРМА ПиэЛСи

Dates

Publication Date

20260506

Application Date

20240625

Priority Date

20230626

Claims (20)

1. 1. A dispersed composition containing ensifentrine, wherein said dispersed composition also contains:
2. from more than 0.00 wt.% to 0.60 wt.% 1,3-bis(2-(2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl)ethyl)urea (BMIQU) relative to the total weight of ensifentrine; and
3. from 0.00 wt.% to 0.50 wt.% of biuret impurity of formula (A) in relation to the total mass of ensifentrine:
4. (A).
5. 2. The dispersed composition according to claim 1, wherein said dispersed composition contains from 0.00 wt.% to 0.30 wt.% of a biuret impurity relative to the total mass of ensifentrine.
6. 3. A dispersed composition according to claim 1 or 2, wherein said dispersed composition contains from 0.00 wt.% to 0.05 wt.% of a biuret impurity relative to the total mass of ensifentrine.
7. 4. A dispersed composition according to any one of claims 1 to 3, wherein said dispersed composition contains from 0.01 wt.% to 0.30 wt.% BMIQU relative to the total weight of ensifentrine.
8. 5. A dispersed composition according to any one of claims 1 to 4, wherein said dispersed composition contains from 0.02 wt.% to 0.06 wt.% BMIQU based on the total weight of ensifentrine.
9. 6. A dispersed composition according to any one of paragraphs 1-5, wherein said dispersed composition also contains:
10. from more than 0.00 wt.% to 0.10 wt.% 1-(2-(9-hydroxy-2-(mesitylimino)-10-methoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl)ethyl)urea (9-des-methyl impurity); and/or
11. from more than 0.00 wt.% to 0.10 wt.% 1-(2-(10-hydroxy-2-(mesitylimino)-9-methoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl)ethyl)urea (10-des-methyl impurity).
12. 7. A dispersed composition according to any one of claims 1 to 6, wherein said dispersed composition contains at least 98.0 wt.% ensifentrine based on the total weight of said dispersed composition.
13. 8. A dispersed composition according to any one of claims 1 to 7, wherein said dispersed composition contains at least 99.0 wt.% ensifentrine based on the total weight of said dispersed composition, optionally at least 99.2 wt.% ensifentrine based on the total weight of said dispersed composition.
14. 9. A dispersed composition according to any one of paragraphs 1-8, wherein said dispersed composition contains:
15. from 99.4 wt.% to 99.9 wt.% ensifentrine;
16. from 0.01 wt.% to 0.30 wt.% BMIQU;
17. from 0.00 wt.% to 0.10 wt.% biuret impurity;
18. from 0.01 wt.% to 0.20 wt.% 9-des-methyl impurity and
19. from 0.01 wt.% to 0.20 wt.% 10-des-methyl impurity,
20. where wt.% is presented in relation to the total mass of the said dispersed composition.