Stabilized difloxacin injectable solution
AssigneeWyeth
InventorHenderik W. Frijlink
Life of this patent
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Abstract
An antibacterial formulation suitable for injection into animals containing approximately 2-10% w/v difloxacin HCI, 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.
Claims15
A pharmaceutical composition suitable for injection into an animal, said composition comprising:
- about 2-10% w/v difloxacin;
- 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.
A pharmaceutical composition suitable for injection into an animal, said composition comprising:
- about 5% w/v difloxacin;
- 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.
A process for preparing a pharmaceutical formulation containing difloxacin, said process comprising simultaneously dissolving difloxacin HCI and L-arginine base in a mixture of water, ethanol, propylene glycol, and optionally benzyl alcohol, at a pH of from 9 to 10 and at a temperature in the approximate range of 10-30° C., wherein on a weight-to-volume basis the free base difloxacin comprises about 2-10%, the L-arginine comprises about 5-20%, the ethanol comprises about 5-15%, the propylene glycol comprises 20-40% and benzyl alcohol comprises 0 to 10% of the formulation.
Dependencies are inferred from the claim text.