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Last Updated: December 22, 2024

Claims for Patent: 9,636,407

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Summary for Patent: 9,636,407

Title:	Caspofungin acetate formulations
Abstract:	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.
Inventor(s):	Jiang; John Zhiqiang (Chicago, IL), Usayapant; Arunya (Mundelein, IL), Bowman; David (Mattawan, MI), Kwok; Keith (Long Grove, IL), Peterson; Joel (New Lenox, IL)
Assignee:	FRESENIUS KABI USA, LLC (Lake Zurich, IL)
Application Number:	13/724,266
Patent Claims:	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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.

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