|Title:||Stable pharmaceutical compositions of dalbavancin and methods of administration|
|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.|
|Inventor(s):|| Cavaleri; Marco (Saronno, IT), Jabes; Daniela (Cassina Rizzardi, IT), Henkel; Timothy (Berwyn, PA), Malabarba; Adriano (Buccinasco, IT), Mosconi; Giorgio (Malvern, PA), Stogniew; Martin (Blue Bell, PA), White; Richard J. (Emeryville, CA) |
|Assignee:|| Vicuron Pharmaceuticals, Inc. (King of Prussia, PA) |
1. A stabilized dry dosage form for reconstitution comprising: dalbavancin; an effective stabilizer comprising mannitol and lactose; wherein the pH of the dosage form is
about 3 to about 5.
2. The dosage form of claim 1, wherein the weight ratio of mannitol to lactose to dalbavancin is about 1:1:4.
3. The dosage form of claim 1, wherein the pH is about 3.5 to about 4.5.
4. The dosage form of claim 1, wherein the pH is about 4.5.