US2017296667A1PendingUtilityA1

Caspofungin Acetate Formulations

59
Assignee: FRESENIUS KABI USA LLCPriority: Nov 20, 2012Filed: Mar 30, 2017Published: Oct 19, 2017
Est. expiryNov 20, 2032(~6.4 yrs left)· nominal 20-yr term from priority
A61K 31/198A61K 38/12A61K 47/20A61K 9/0019A61K 9/19A61K 47/183
59
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Claims

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.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition, comprising:
 caspofungin acetate, and   at least one an amino acid;   where the composition is a solid.   
     
     
         2 . The composition of  claim 1 , where the at least one amino acid comprises an amino acid having at least two primary or secondary amine groups. 
     
     
         3 . The composition of  claim 2 , where the at least one amino acid is an amino acid selected from the group consisting of arginine, asparagine, lysine, methyl lysine, and ornithine. 
     
     
         4 . The composition of  claim 1 , where the at least one amino acid is selected from the group consisting of alanine, 4-aminobutanoic acid, 3-aminopentanoic acid, 5-aminopentanoic acid, 6-aminohexanoic acid, 8-aminooctanoic acid, arginine, aspartic acid, asparagine, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, methyl lysine, ornithine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine. 
     
     
         5 . The composition of  claim 1 , where the at least one amino acid is selected from the group consisting of 6-aminohexanoic acid, arginine, asparagine, glycine, lysine, methyl lysine, and ornithine. 
     
     
         6 . The composition of  claim 1 , where the at least one amino acid comprises at least two amino acids. 
     
     
         7 . The composition of  claim 1 , comprising from 10 to 150 mg caspofungin acetate. 
     
     
         8 . The composition of  claim 1 , comprising from 25 to 100 mg caspofungin acetate. 
     
     
         9 . The composition of  claim 1 , comprising from 50 to 70 mg caspofungin acetate. 
     
     
         10 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 3:5. 
     
     
         11 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 1:1. 
     
     
         12 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 2:1. 
     
     
         13 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is at most 3:1. 
     
     
         14 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is at most 2:1. 
     
     
         15 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 2:5 to 3:1. 
     
     
         16 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 3:5 to 2:1. 
     
     
         17 . The composition of  claim 1 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 1:1 to 3:1. 
     
     
         18 . A composition, formed by a method comprising:
 forming a liquid mixture comprising
 a solvent, 
 caspofungin acetate, and 
 at least one an amino acid; and 
   lyophilizing the liquid mixture to form a solid composition.   
     
     
         19 . The composition of  claim 18 , where the at least one amino acid is an amino acid having at least two primary or secondary amine groups. 
     
     
         20 . The composition of  claim 19 , where the at least one amino acid is an amino acid selected from the group consisting of arginine, asparagine, lysine, methyl lysine, and ornithine. 
     
     
         21 . The composition of  claim 18 , where the at least one amino acid is selected from the group consisting of alanine, 4-aminobutanoic acid, 3-aminopentanoic acid, 5-aminopentanoic acid, 6-aminohexanoic acid, 8-aminooctanoic acid, arginine, aspartic acid, asparagine, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, methyl lysine, ornithine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine. 
     
     
         22 . The composition of  claim 18 , where the at least one amino acid is selected from the group consisting of 6-aminohexanoic acid, arginine, asparagine, glycine, lysine, methyl lysine, and ornithine. 
     
     
         23 . The composition of  claim 18 , where the at least one amino acid comprises at least two amino acids. 
     
     
         24 . The composition of  claim 18 , comprising from 10 to 150 mg caspofungin acetate. 
     
     
         25 . The composition of  claim 18 , comprising from 25 to 100 mg caspofungin acetate. 
     
     
         26 . The composition of  claim 18 , comprising from 50 to 70 mg caspofungin acetate. 
     
     
         27 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 3:5. 
     
     
         28 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 1:1. 
     
     
         29 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is at least 2:1. 
     
     
         30 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is at most 3:1. 
     
     
         31 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is at most 2:1. 
     
     
         32 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 2:5 to 3:1. 
     
     
         33 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 3:5 to 2:1. 
     
     
         34 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate is from 1:1 to 3:1. 
     
     
         35 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate in the liquid mixture is at least 2:5. 
     
     
         36 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate in the liquid mixture is at least 3:5. 
     
     
         37 . The composition of  claim 18 , where the mass ratio of the at least one amino acid to caspofungin acetate in the liquid mixture is at least 1:1. 
     
     
         38 . A composition, comprising:
 from 50 to 70 mg caspofungin acetate, and arginine;   where the mass ratio of arginine to caspofungin acetate is from 2:5 to 3:1, and the composition is solid.   
     
     
         39 . The composition of  claim 38 , where the mass ratio of arginine to caspofungin acetate is from 3:5 to 2:1. 
     
     
         40 . The composition of  claim 38 , where the mass ratio of arginine to caspofungin acetate is from 1:1 to 3:1.

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