Stable compositions of dalbavancin

Abstract

The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.

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 , C 0 , and C 1 ;    wherein the content of factor B 0  is not less than about 75 mole percent of all dalbavancin components present and    wherein a content of MAG does not exceed about 4 mole percent 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 is mannitol.  
     
     
         4 . The dosage form of  claim 2 , wherein the stabilizing substance is a mixture of mannitol and lactose.  
     
     
         5 - 14 . (Canceled)  
     
     
         15 . A pharmaceutical composition 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 , C 0 , and C 1 ; and    wherein the content of factor B 0  is not less than about 75 mole percent of all dalbavancin components present, and    wherein a content of MAG does not exceed 4 mole percent of all dalbavancin components present.    
     
     
         16 . The pharmaceutical composition of  claim 15 , further comprising a stabilizing substance.  
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the stabilizing substance is mannitol.  
     
     
         18 . The pharmaceutical composition of  claim 16 , wherein the stabilizing substance is a mixture of mannitol and lactose.  
     
     
         19 - 28 . (Canceled)  
     
     
         29 . 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 MAG; and    wherein the content of factor B 0  is not less than about 75 mole percent of all dalbavancin components present and    wherein the content of MAG does not exceed about 4 mole percent of all dalbavancin components present.    
     
     
         30 . The dosage form of  claim 29 , further comprising a stabilizing substance.  
     
     
         31 . The dosage form of  claim 30 , wherein the stabilizing substance is mannitol.  
     
     
         32 . The dosage form of  claim 30 , wherein the stabilizing substance is a mixture of mannitol and lactose.  
     
     
         33 - 42 . (Canceled)  
     
     
         43 . A pharmaceutical composition comprising: 
 dalbavancin factor Bo and MAG; and    wherein the content of factor Bo is not less than about 75 mole percent of all dalbavancin components present, and    wherein the content of MAG does not exceed 4 mole percent of all dalbavancin components present.    
     
     
         44 . The pharmaceutical composition of  claim 43 , further comprising a stabilizing substance.  
     
     
         45 . The pharmaceutical composition of  claim 44 , wherein the stabilizing substance is mannitol.  
     
     
         46 . The pharmaceutical composition of  claim 44 , wherein the stabilizing substance is a mixture of mannitol and lactose.  
     
     
         47 - 56 . (Canceled)