IP Library › Granted Patent US 6,872,723
Granted Patent B2
US 6,872,723 · App. 10/346,597 · Granted Mar 29, 2005

Stabilized difloxacin injectable solution

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Quick Facts
Patent No.
US 6,872,723
App. No.
10/346,597
Granted
Mar 29, 2005
Kind
B2
Abstract

An antibacterial formulation suitable for injection into animals containing approximately 2-10% w/v difloxacin HCl, L-arginine base, propylene glycol, ethanol and/or benzyl alcohol, and water. The formulation is a solution having a pH of form 9 to 10. The formulation produces little or no tissue damage or irritation at the injection site.

Claims (10)

1. A pharmaceutical composition suitable for injection into an animal, said composition comprising: about 2-10% w/v difloxacin HCl; 5-20% w/v L-arginine base; about 5-15% w/v ethanol; up to about 10% w/v of an anti-microbial preservative; propylene glycol, glycerol, a soluble polyethylene glycol, or a combination thereof; and water, wherein said composition has a pH in the approximate range of 9-10.

2. A composition according to claim 1 , wherein said difloxacin HCl concentration is about 4-6% difloxacin HCl.

3. A composition according to claim 2 , comprising approximately 20-40% propylene glycol and 5-15% L-arginine base, wherein said anti-microbial preservative is selected from the group consisting of benzyl alcohol, phenol, chlorocresol, and mixtures thereof.

4. A composition according to claim 3 wherein the pH is in the approximate range of 9.1-9.6.

5. A composition according to claim 3 wherein said preservative is benzyl alcohol.

6. A composition according to claim 2 wherein the pH is in the approximate range of 9.1-9.6.

7. A composition according to claim 1 wherein the pH is in the approximate range of 9.1-9.6.

8. A composition according to claim 1 further comprising potassium hydroxide.

9. A composition according to claim 8 wherein said preservative is benzyl alcohol, and the pH is in the approximate range of 9.1-9.6.

10. A pharmaceutical composition suitable for injection into an animal, said composition comprising: about 5% w/v difloxacin HCl; 10% w/v L-arginine base; about 10% w/v ethanol; about 5% w/v benzyl alcohol; about 30% w/v propylene glycol; and water, wherein said composition has a pH in the approximate range of 9.1-9.6.