Stabilized difloxacin injectable solution

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.

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         15 : A method of treating a bacterial infection in an animal in need thereof comprising the step of administering to the animal by injection a therapeutically effective amount of a pharmaceutical 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.  
     
     
         16 : The method according to  claim 15 , wherein the composition comprises about 4-6% w/v difloxacin HCl.  
     
     
         17 : The method according to  claim 16 , wherein the composition comprises approximately 20-40% propylene glycol and 5-15% L-arginine base; and the anti-microbial preservative is selected from the group consisting of benzyl alcohol, phenol, chlorocresol and a mixture thereof.  
     
     
         18 : The method according to  claim 15 , wherein the pH of the composition is in the approximate range of 9.1-9.6.  
     
     
         19 : The method according to  claim 16 , wherein the pH of the composition is in the approximate range of 9.1-9.6.  
     
     
         20 : The method according to  claim 17 , wherein the pH of the composition is in the approximate range of 9.1-9.6.  
     
     
         21 : The method according to  claim 17 , wherein the preservative of the composition is benzyl alcohol.  
     
     
         22 : The method according to  claim 15 , wherein the composition further comprises potassium hydroxide.  
     
     
         23 : The method according to  claim 22 , wherein the preservative of the composition is benzyl alcohol and the pH of the composition is in the approximate range of 9.1-9.6.  
     
     
         24 : A method of treating a bacterial infection in an animal in need thereof comprising the step of administering to the animal by injection a therapeutically effective amount of a pharmaceutical 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.