Pharmaceutical formulation

Abstract

Pharmaceutical formulations comprising amoxycillin and clavulanate in a ratio of from 10:1 to 20:1 are of use in the emperic treatment of infections potentially caused by DRSP.

1 . A pharmaceutical formulation comprising amoxycillin and clavulanate in a weight ratio between 10:1 and 20:1 inclusive.  
     
     
         2 . A formulation as claimed in    claim 1    in which the ratio of amoxycillin to clavulante is between 12:1 and 16:1 inclusive.  
     
     
         3 . A formulation as claimed in    claim 1    in which the ratio of amoxycillin to clavulante is about 14:1.  
     
     
         4 . A formulation as claimed in any one of    claims 1    to    3    in which amoxycillin is in the form of amoxycillin trihydrate.  
     
     
         5 . A formulation as claimed in any one of    claims 1    to    4    in which clavulanate is in the form of potassium clavulanate.  
     
     
         6 . A formulation as claimed in any one of    claims 1    to    5    adapted for administration to paediatric patients in the form of a powder or granular product for reconstitution into a suspension or solution and which comprises from 500 to 700mg/5 ml of amoxycillin and from 35 to 50 mg/5 ml of clavulanate when reconstituted.  
     
     
         7 . A formulation as claimed in any one of    claims 1    to    5    in the form of tablets and adapted to provide about 1750 mg amoxycillin and 125 mg clavulanate per unit dose.  
     
     
         8 . A formulation as claimed in    claim 7    comprising a first tablet comprising 875 mg amoxycillin and 125 mg clavulanate and a second tablet comprising 875 mg amoxycillin.  
     
     
         9 . A process for preparing a pharmaceutical formulation according to any one of the preceding claims which process comprises admixing the ingredients thereof in any order that is convenient.  
     
     
         10 . The use of amoxycillin and clavulanate in a ratio of between 10:1 and 20:1 inclusive in the manufacture of a medicament for oral administration for the empiric treatment of infections potentially caused by DRSP in human patients.  
     
     
         11 . A method for the empiric treatment of infections potentially caused by DRSP in a human patient comprising the oral administration to a patient in need thereof of a pharmaceutical formulation comprising amoxycillin and clavulanate in a weight ratio between 10:1 and 20:1 inclusive.  
     
     
         12 . A method as claimed in    claim 11    in which the dosage quantity for paediatric patients is 75 to 115 mg/kg amoxycillin per day and from 5 to 7.5 mg/kg of clavulanate per day.  
     
     
         13 . A method as claimed in    claim 12    in which the dosage quantity is 90±10% mg/kg amoxycillin and 6.4±10% mg/kg clavulanate.  
     
     
         14 . A method as claimed in    claim 11    in which the dosage amount for an older child or an adult patient is 3500±10% mg amoxycillin and 250±10% mg clavulanate.  
     
     
         15 . A method as claimed in    claim 13    or    claim 14    in which the dosage is administered bid.