Treatment of Sepsis with 5-Ethyl-1-Phenyl-2(1H)-Pyridone

Abstract

A pharmaceutical composition comprising 5-ethyl-1-phenyl-2-(1H)-pyridone (5-EPP) and its use for the treatment of sepsis are disclosed.

We claim: 
     
         1 . A pharmaceutical product for the treatment of sepsis comprising purified 5-ethyl-1-phenyl-2-(1H)-pyridone in a pharmaceutical carrier suitable for injection. 
     
     
         2 . The pharmaceutical product of  claim 1 , wherein said purified 5-ethyl-1-phenyl-2-(1H)-pyridone is dissolved in a pharmaceutical carrier and is suitable for administration via a route selected from Intramuscular injection, intraperitoneal injection, intravenous injection, and intravenous infusion into an animal. 
     
     
         3 . The pharmaceutical product of  claim 2  wherein said carrier is selected from water, saline and propylene glycol and combinations thereof. 
     
     
         4 . The pharmaceutical product of  claim 3 , wherein said carrier is isotonic saline and said 5-ethyl-1-phenyl-2-(1H)-pyridone has a concentration of 20 mg/mL or less and is colorless at room temperature. 
     
     
         5 . The pharmaceutical product of  claim 1 , comprising a solution of purified 5-ethyl-1-phenyl-2-(1H)-pyridone and a diluent selected from water and saline, wherein the concentration of said solution is from about 20 mg/mL to about 30 mg/mL, and wherein said solution is characterized by being clear at room temperature without any visible precipitate. 
     
     
         6 . The pharmaceutical product of  claim 5 , wherein the concentration of said solution is about 20 mg/mL. 
     
     
         7 . The pharmaceutical product of  claim 5 , wherein said diluent is water and the pH is about 7.2 to 7.4. 
     
     
         8 . The pharmaceutical product of  claim 5 , wherein said diluent is saline and the pH is about 6.1 to 6.3. 
     
     
         9 . The pharmaceutical product according to  claim 1 , comprising a solution which is colorless and stable at room temperature and which is made according to the steps of: adding an amount of solid 5-ethyl-1-phenyl-2-(1H)—pyridone to a solubilization zone, adding an amount of diluent selected from water and saline to said solid 5-ethyl-1-phenyl-2-(1H)-pyridone to the final desired volume, applying heat to said solubilization zone of about 40 to 45 degrees Celsius, applying sonication to said solubilization zone until complete dissolution occurs, allowing said solution to return to room temperature whereby said colorless stable 5-ethyl-1-phenyl-2-(1H)-pyridone solution is formed. 
     
     
         10 . The pharmaceutical product of  claim 9  wherein the concentration of said 5-ethyl-1-phenyl-2-(1H)-pyridone is from about 20 mg/mL to about 30 mg/mL. 
     
     
         11 . The pharmaceutical product of  claim 10 , wherein said concentration of said 5-ethyl-1-phenyl-2-(1H)-pyridone is 20 mg/mL. 
     
     
         12 . The pharmaceutical product of  claim 9 , wherein said solubilization zone is a vessel made from a material selected from polypropylene and polystyrene.