Claims
- 1. A dosage form of dalbavancin for parenteral use comprising:
a sterile, stable, particle-free dalbavancin powder suitable for reconstitution with a pharmaceutically acceptable vehicle; and a stabilizer, wherein the dosage form is at a pH of about 3-5.
- 2. The dosage form of claim 1, wherein the stabilizer comprises sugar.
- 3. The dosage form of claim 2, wherein the sugar is selected from the group consisting of mannitol, lactose, sucrose, sorbitol, glycerol, cellulose, trehalose, maltose, dextrose, and combinations thereof.
- 4. The dosage form of claim 1, wherein the stabilizer is mannitol.
- 5. The dosage form of claim 4, wherein the weight ratio of mannitol: dalbavancinis 1:2.
- 6. The dosage form of claim 1, wherein the stabilizer is lactose.
- 7. The dosage form of claim 1, wherein the stabilizer is a mixture of mannitol and lactose.
- 8. The dosage form of claim 7, wherein the weight ratio of mannitol:lactose:dalbavancin is 1:1:4.
- 9. The dosage form of claim 8, wherein the pH is 4.5.
- 10. The dosage form of claim 1, wherein the pH is 3.5.
- 11. The dosage form of claim 1, wherein the pH is 4.5.
- 12-24. (canceled)
- 25. A dosage form of dalbavancin for parenteral use comprising:
a sterile, stable, particle-free dalbavancin powder suitable for reconstitution with a pharmaceutically acceptable vehicle and mannitol at a pH of about 3-5.
- 26. The dosage form of claim 25, wherein the pharmaceutical composition further comprises lactose.
- 27. The dosage form of claim 25, wherein the pH is about 3.5.
- 28-32. (canceled)
- 33. A pharmaceutical composition comprising:
dalbavancin; and a stabilizer, wherein the stabilizer comprises mannitol and lactose.
- 34. The pharmaceutical composition of claim 33, wherein the weight ratio of mannitol:lactose:dalbavancin is 1:1:4.
- 35. The pharmaceutical composition of claim 33, wherein the pharmaceutical composition has a pH of about 3 to 5.
- 36. The pharmaceutical composition of claim 33, wherein the pharmaceutical composition has a pH of about 4.5.
- 37-66. (canceled)
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser. No. 10/714,261, filed Nov. 14, 2003, which claims the benefit of U.S. Provisional Patent Application Serial Nos. 60/427,654, filed Nov. 18, 2002, 60/485,694, filed Jul. 8, 2003, 60/495,048, filed Aug. 13, 2003, and 60/496,483, filed Aug. 19, 2003, the disclosures of all of which are incorporated herein by reference in their entireties.
Provisional Applications (4)
|
Number |
Date |
Country |
|
60427654 |
Nov 2002 |
US |
|
60485694 |
Jul 2003 |
US |
|
60495048 |
Aug 2003 |
US |
|
60496483 |
Aug 2003 |
US |
Continuations (1)
|
Number |
Date |
Country |
Parent |
10714261 |
Nov 2003 |
US |
Child |
10828439 |
Apr 2004 |
US |