Dalbavancin compositions for treatment of bacterial infections

Abstract

The invention provides dosage forms and compositions for treatment of bacterial infections. The dosage form may include a sterile, stable, particle-free dalbavancin powder suitable for reconstitution with a pharmaceutically acceptable vehicle. The dosage form may include a dalbavancin factor B 0 and at least one additional dalbavancin factor among A 0 , A 1 , B 1 , B 2 , C 0 , and C 1 . The dosage form may also include a stabilizing substance.

1 . A dosage form comprising:
 a sterile, stable, particle-free dalbavancin powder suitable for reconstitution with a pharmaceutically acceptable vehicle comprising dalbavancin factor B 0  and at least one additional dalbavancin factor selected from the group consisting of dalbavancin factors A 0 , A 1 , B 1 , B 2 , C 0 , and C 1 ;   wherein the content of factor B 0  is not less than about 75 percent HPLC distribution of all dalbavancin components present.   
     
     
         2 . The dosage form of  claim 1 , further comprising a stabilizing substance. 
     
     
         3 . The dosage form of  claim 2 , wherein the stabilizing substance comprises mannitol. 
     
     
         4 . The dosage form of  claim 2 , wherein the stabilizing substance comprises lactose. 
     
     
         5 . The dosage form of  claim 2 , wherein the stabilizing substance comprises a mixture of mannitol and lactose. 
     
     
         6 . The dosage form of  claim 1 , further comprising isoB 0 , wherein the content of isoB 0  does not exceed about 3.5 percent HPLC distribution of all dalbavancin components present. 
     
     
         7 . The dosage form of  claim 1 , wherein the dosage form comprises dalbavancin factors B 0 , A 0 , A 1 , B 1 , and B 2 . 
     
     
         8 . The dosage form of  claim 1 , wherein the content of factor B 0  is at least about 80 percent HPLC distribution of all dalbavancin components present. 
     
     
         9 . The dosage form of  claim 1 , wherein the content of factor B 0  is at least about 85 percent HPLC distribution of all dalbavancin components present. 
     
     
         10 . The dosage form of  claim 1 , wherein the content of factor B 0  is at least about 90 percent HPLC distribution of all dalbavancin components present. 
     
     
         11 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 3.0 percent HPLC distribution of all dalbavancin components present. 
     
     
         12 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 2.5 percent HPLC distribution of all dalbavancin components present. 
     
     
         13 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 2 percent HPLC distribution of all dalbavancin components present. 
     
     
         14 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 1.5 percent HPLC distribution of all dalbavancin components present. 
     
     
         15 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 1 percent HPLC distribution of all dalbavancin components present. 
     
     
         16 . The dosage form of  claim 6 , wherein the content of isoB 0  does not exceed about 0.5 percent HPLC distribution of all dalbavancin components present. 
     
     
         17 . The dosage form of  claim 1 , further comprising MAG, wherein the content of MAG does not exceed about 5 percent HPLC distribution of all dalbavancin components present after about 40° C. after about 3-6 months. 
     
     
         18 . The dosage form, of  claim 1 , wherein the dosage form degrades by no more than about 4% at about 25° C. after about 2 years. 
     
     
         19 . The dosage form of  claim 2 , wherein the dosage form has a pH of about 3-5. 
     
     
         20 . The dosage form of  claim 2 , wherein the dosage form has a pH of about 4-5.