DALBAVANCIN COMPOSITIONS FOR TREATMENT OF BACTERIAL INFECTIONS
The invention provides methods for drying dalbavancin. The method includes providing wet dalbavancin that includes dalbavancin, water, and a solvent. The wet dalbavancin is dried at at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the water level of the wet dalbavancin is less than about 20% (w/w). Water is then added to the dalbavancin and the resulting wet dalbavancin is dried at least once more at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the solvent level of the dalbavancin is less than about 3.0% (w/w).
1 . A method for drying dalbavancin, comprising the steps of:
providing wet dalbavancin comprising dalbavancin, water, and a solvent;
drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the water level of the wet dalbavancin is less than about 20% (w/w);
adding water to the dalbavancin; and
drying the wet dalbavancin at least once more at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less, until the solvent level of the dalbavancin is less than about 3.0% (w/w).
2 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 3.0% (w/w).
3 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 2.5% (w/w).
4 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 2.0% (w/w).
5 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 1.5% (w/w).
6 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 1.0% (w/w).
7 . The method of claim 1 , wherein the steps of adding water and drying the wet dalbavancin at a temperature of about 30° C. or less, at a vacuum pressure of about 50 mbar or less are repeated until the solvent level is less than about 0.5% (w/w).
8 . The method of claim 1 , wherein the solvent is acetone.
9 . The method of claim 1 , wherein the solvent is selected from the group consisting of ethanol, methanol, propanol, butanol, ether, methylene chloride, tetrahydrofuran, chloroform, 1,4-dioxane, and trichloroethylene.
10 . The method of claim 1 , wherein the wet dalbavancin is dried at a temperature of about 28° C. or less.
11 . The method of claim 1 , wherein the wet dalbavancin is dried at a temperature of about 26° C. or less.
12 . The method of claim 1 , wherein the wet dalbavancin is dried at a temperature of about 24° C. or less.
13 . The method of claim 1 , wherein the wet dalbavancin is dried at a vacuum pressure of about 40 mbar or less.
14 . The method of claim 1 , wherein the wet dalbavancin is dried at a vacuum pressure of about 30 mbar or less.
15 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 3.0 percent HPLC distribution.
16 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 2.5 percent HPLC distribution.
17 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 2.0 percent HPLC distribution.
18 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 1.5 percent HPLC distribution.
19 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 1.0 percent HPLC distribution.
20 . The method of claim 1 , wherein the wet dalbavancin further comprises MAG and wherein, after drying, the MAG is present in less than about 0.5 percent HPLC distribution.