POLYENE MACROLIDE COMPOSITIONS AND THEIR USES

Claims

This invention relates to lyophilized pharmaceutical compositions that include therapeutic polyene macrolides to increase the bioavailability and shelf life of the compositions.

1. A lyophilized pharmaceutical composition comprising a cryoprotectant and a compound of formula (I), or a pharmaceutically acceptable salt thereof.

22. An aqueous solution prepared by reconstituting the lyophilized pharmaceutical composition of any of claims 1 to 21 with an aqueous carrier.

30. A method for administering a compound of formula (I) or Compound 1 to a subject in need thereof, comprising: (a) providing the lyophilized pharmaceutical composition according to any one of claims 1 to 21; (b) reconstituting the composition of step (a) in an aqueous carrier to form a solution comprising the compound of formula (I) or Compound 1; and (c) within at least 5 minutes of completing step (b), administering the reconstituted solution of step (b) to the subject.

34. A method for preparing the freeze-dried composition of any of claims 1 to 21, comprising: (a) dissolving the compound of formula (I) or Compound 1 in an organic solvent; (b) dissolving a cryoprotectant and a stabilizer in water in container 2, followed by mixing; (c) combining the mixtures of step (a) and step (b) in a single container, followed by mixing; (d) adjusting the pH of the mixture of step (c) to between 4.4 and 5.5 to achieve a completely dissolved mixture; (e) filtering the mixture of step (d); (f) freeze-drying the mixture of step (e); and (g) storing the freeze-dried composition of step (f) at a temperature starting at least -15°C.

38. A lyophilized pharmaceutical composition comprising a stabilizer and a compound of formula (I), or a pharmaceutically acceptable salt thereof.

59. An aqueous solution prepared by reconstituting the lyophilized pharmaceutical composition of any of claims 38 to 58 with an aqueous carrier.