Caspofungin acetate formulations
View Patent ↗A caspofungin composition includes caspofungin acetate and at least one amino acid, where the composition is a solid. The solid composition may be made by forming a liquid mixture including a solvent, caspofungin acetate and the amino acid(s), and lyophilizing the liquid mixture.
1. A composition, comprising:
from 10 to 150 mg of caspofungin acetate, and
arginine, where the mass ratio of the arginine to caspofungin acetate is from 1:1 to 3:1;
where the composition is a solid.
2. The composition of claim 1 , comprising from 25 to 100 mg caspofungin acetate.
3. The composition of claim 1 , comprising from 50 to 70 mg caspofungin acetate.
4. The composition of claim 1 , where the mass ratio of the arginine to caspofungin acetate is 2:1.
5. A composition, comprising:
50 mg caspofungin acetate, and
arginine;
where the mass ratio of arginine to caspofungin acetate is from 1:1 to 3:1, and
the composition is a solid.
6. The composition of claim 5 , where the mass ratio of arginine to caspofungin acetate is 2:1.
7. A composition, formed by a method comprising:
forming a liquid mixture comprising
a solvent,
from 10 to 150 mg of caspofungin acetate, and
arginine, where the mass ratio of arginine to caspofungin acetate is from 1:1 to 3:1; and
lyophilizing the liquid mixture to form a solid composition.
8. The composition of claim 7 , comprising from 25 to 100 mg caspofungin acetate.
9. The composition of claim 7 , comprising from 50 to 70 mg caspofungin acetate.
10. The composition of claim 7 , where the mass ratio of arginine to caspofungin acetate is 2:1.
11. The composition of claim 1 , wherein following storage of the composition at 25° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 1.0% as determined by peak area percent using High Pressure Liquid Chromatography.
12. The composition of claim 1 , wherein following storage of the composition at 40° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 2.0% as determined by peak area percent using High Pressure Liquid Chromatography.
13. The composition of claim 5 , wherein following storage of the composition at 25° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 1.0% as determined by peak area percent using High Pressure Liquid Chromatography.
14. The composition of claim 5 , wherein following storage of the composition at 40° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 2.0% as determined by peak area percent using High Pressure Liquid Chromatography.
15. The composition of claim 6 , wherein following storage of the composition at 25° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 1.0% as determined by peak area percent using High Pressure Liquid Chromatography.
16. The composition of claim 6 , wherein following storage of the composition at 40° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 2.0% as determined by peak area percent using High Pressure Liquid Chromatography.
17. A composition, comprising:
70 mg caspofungin acetate, and
arginine;
where the mass ratio of arginine to caspofungin acetate is from 1:1 to 3:1, and
the composition is a solid.
18. The composition of claim 17 , where the mass ratio of arginine to caspofungin acetate is 2:1.
19. The composition of claim 17 , wherein following storage of the composition at 25° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 1.0% as determined by peak area percent using High Pressure Liquid Chromatography.
20. The composition of claim 17 , wherein following storage of the composition at 40° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 2.0% as determined by peak area percent using High Pressure Liquid Chromatography.
21. The composition of claim 18 , wherein following storage of the composition at 25° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 1.0% as determined by peak area percent using High Pressure Liquid Chromatography.
22. The composition of claim 18 , wherein following storage of the composition at 40° C. for a period of 29 days, the amount of total impurities present in the composition is not more than 2.0% as determined by peak area percent using High Pressure Liquid Chromatography.