Bisphosphocin gel formulations and uses thereof

Abstract

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

1 - 24 . (canceled) 
     
     
         25 . A method of treating an infection in a patient in need thereof, the method comprising administering an effective amount of the formulation of claim  1  to the patient an effective amount of a gel formulation comprising from about 1% to about 30% (weight/weight) of a Nu-3, or a pharmaceutically acceptable salt thereof; from about 1% to about 20% (weight/weight) of a fatty alcohol thickening agent from about 0.25% to about 15% (weight/weight) of a nonionic polymer emulsifier; and from about 1% to about 35% (weight/weight) of a diluent; and wherein the formulation has a pH of about pH 1 to about pH 3. 
     
     
         26 . The method of  claim 25 , wherein the infection is an infection of a diabetic foot ulcer or a complicated venous leg ulcer. 
     
     
         27 . The method of  claim 25 , wherein the infection is an infection of a burn wound. 
     
     
         28 . The method of  claim 25 , wherein the infection is an infection of a wound or ulcer. 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . The method of  claim 25 , wherein the patient is administered at least one additional active ingredient. 
     
     
         35 . The method of  claim 25 , wherein the patient is a human. 
     
     
         36 . The method of  claim 25 , 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, and oleyl alcohol. 
     
     
         37 . The method of  claim 25 , wherein the nonionic polymer is selected from the group consisting of ceteth-20, steareth-20, and ceteareth-20. 
     
     
         38 . The method of  claim 25 , wherein the diluent is selected from the group consisting of water, glycerol, mannitol, saline, and phosphate buffered saline. 
     
     
         39 . The method of  claim 25 , wherein the administration is topical administration. 
     
     
         40 . The method of  claim 25 , wherein the Nu-3, or a pharmaceutically acceptable salt thereof, is present in the formulation in an amount from about 10% to about 20% (weight/weight). 
     
     
         41 . The method of  claim 25 , wherein the Nu-3, or a pharmaceutically acceptable salt thereof, is present in the formulation in an amount from about 5% to about 15% (weight/weight). 
     
     
         42 . The method of  claim 25 , wherein the Nu-3, or a pharmaceutically acceptable salt thereof, is present in the formulation in an amount from about 20% to about 30% (weight/weight). 
     
     
         43 . The method of  claim 25 , wherein the fatty alcohol thickening agent is present in the formulation in an amount from about 1% to about 10% (weight/weight). 
     
     
         44 . The method of  claim 25 , wherein the nonionic polymer emulsifier is present in the formulation in an amount from about 0.5% to about 5% (weight/weight). 
     
     
         45 . The method of  claim 25 , 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. 
     
     
         46 . The method of  claim 25 , 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. 
     
     
         47 . The method of  claim 25 , wherein the administration is carried out as a multiple dose regimen. 
     
     
         48 . The method of  claim 26 , wherein the administration is carried out one or more times per day. 
     
     
         49 . The method of  claim 25 , wherein the formulation comprises from about 1% to about 30% (weight/weight) of the Nu-3, or a pharmaceutically acceptable salt thereof; from about 1% to about 20% (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, and oleyl alcohol; from about 0.25% to about 15% (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, and steareth-100; and from about 1% to about 35% (weight/weight) of a diluent selected from the group consisting of water, glycerol, mannitol, saline, and phosphate buffered saline.