Bisphosphocin gel formulations and uses thereof

Abstract

Gel formulations having antimicrobial activity are disclosed. Methods of using the gel formulation are further disclosed.

1 - 35 . (canceled) 
     
     
         36 . A method of treating an infection in a patient in need thereof, the method comprising administering to the patient an effective amount of a formulation comprising:
 from about 1% to about 20% (weight/weight) of a Nu-3 having the formula:   
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof;
 from about 1% to about 10% (weight/weight) of a fatty alcohol thickening agent; 
 from about 0.5% to about 5% (weight/weight) of a nonionic polymer emulsifier; and 
 from about 65% to about 97.5% (weight/weight) of a diluent. 
 
     
     
         37 . The method of  claim 36 , wherein the patient is administered at least one additional active ingredient. 
     
     
         38 . The method of  claim 36 , wherein the patient is a human. 
     
     
         39 . The method of  claim 36 , wherein the fatty alcohol thickening agent is selected from the group consisting of cetyl alcohol, lauryl alcohol, stearyl alcohol, cetostearyl alcohol, myristyl alcohol, docosanol alcohol, oleyl alcohol, and combinations thereof. 
     
     
         40 . The method of  claim 36 , wherein the nonionic polymer is selected from the group consisting polysorbate 20, polysorbate 60, polysorbate 80, ceteareth-12, ceteareth-20, ceteareth-30, ceteth-10, ceteth-20, steareth-10, steareth-20, steareth-40, steareth-100, and combinations thereof. 
     
     
         41 . The method of  claim 36 , wherein the diluent is selected from the group consisting of water, glycerol, mannitol, saline, phosphate buffered saline, and combinations thereof. 
     
     
         42 . The method of  claim 36 , wherein the administration is topical administration. 
     
     
         43 . The method of  claim 36 , wherein the Nu-3, or a pharmaceutically acceptable salt thereof, is present in the formulation in an amount from about 1% to about 15% (weight/weight). 
     
     
         44 . The method of  claim 36 , wherein the fatty alcohol thickening agent is present in the formulation in an amount from about 2% to about 8% (weight/weight). 
     
     
         45 . The method of  claim 36 , wherein the nonionic polymer emulsifier is present in the formulation in an amount greater than about 0.5% (weight/weight). 
     
     
         46 . The method of  claim 36 , further comprising from about 1% to about 10% (weight/weight) of an acid selected from the group consisting of hydrochloric acid, hydrobromic acid, hydroiodic acid, nitric acid, carbonic acid, sulfuric acid, and phosphoric acid. 
     
     
         47 . The method of  claim 36 , wherein the Nu-3, or a pharmaceutically acceptable salt thereof, is administered to the patient at a dose from about 1 to about 500 mg of Nu-3, or a pharmaceutically acceptable salt thereof, per kg of patient body weight. 
     
     
         48 . The method of  claim 36 , wherein the administration is carried out as a multiple dose regimen. 
     
     
         49 . The method of  claim 36 , wherein the administration is carried out one or more times per day. 
     
     
         50 . The method of  claim 36 , wherein the formulation comprises:
 from about 1% to about 20% (weight/weight) of the Nu-3, or a pharmaceutically acceptable salt thereof;   from about 1% to about 10% (weight/weight) of a fatty alcohol thickening agent selected from the group consisting of cetyl alcohol, lauryl alcohol, stearyl alcohol, cetostearyl alcohol, myristyl alcohol, docosanol alcohol, oleyl alcohol, and combinations thereof;   from about 0.5% to about 5% (weight/weight) of a nonionic polymer emulsifier selected from the group consisting of polysorbate 20, polysorbate 60, polysorbate 80, ceteareth-12, ceteareth-20, ceteareth-30, ceteth-10, ceteth-20, steareth-10, steareth-20, steareth-40, steareth-100, and combinations thereof; and   from about 65% to about 97.5% (weight/weight) of a diluent selected from the group consisting of water, glycerol, mannitol, saline, phosphate buffered saline, and combinations thereof.   
     
     
         51 . The method of  claim 36 , wherein the infection is selected from the group consisting of an infection of an ulcer, an infection of a wound, and an otitis externa infection. 
     
     
         52 . The method of  claim 36 , wherein the infection is selected from the group consisting of acne vulgaris, onychomycosis, conjunctivitis, oral mucositis, an infection of a mucosal surface, a vaginal infection, and combinations thereof. 
     
     
         53 . The method of  claim 36 , wherein the infection is an infection of a diabetic foot ulcer or a complicated venous leg ulcer. 
     
     
         54 . The method of  claim 36 , wherein the infection is an infection of a burn wound. 
     
     
         55 . The method of  claim 36 , wherein the infection is an infection of a wound or ulcer.