Agglomerates by crystallisation

Abstract

The present invention describes novel agglomerates in crystalline form of β-lactum compounds, Furthermore, a process for the preparation of said agglomerates, wherein a solution or suspension of at least one β-lactum compound in a solvent is mixed with one or more anti-solvents has been described.

1 . A composition comprising agglomerates of potassium clavulanate crystals, said agglomerates having an average particle size of 50-250 μm, said composition having a weight percentage of between 0% and 10% potassium clavulanate crystals in the needle form, with the proviso that the rosette-like crystalline form of potassium clavulanate is excluded. 
     
     
         2 . The composition of  claim 1 , wherein said agglomerates have a compressibility of 11-28% calculated as 100 times the ratio of the difference between tapped bulk density and loose bulk density to the tapped bulk density. 
     
     
         3 . The composition of  claim 1 , further comprising amoxicillin. 
     
     
         4 . The composition of  claim 1 , further comprising at least one excipient. 
     
     
         5 . The composition of  claim 4 , wherein said at least one excipient is selected from the group consisting of microcrystalline cellulose and silica. 
     
     
         6 . A pharmaceutical formulation comprising the composition of  claim 1  and at least one pharmaceutically acceptable excipient. 
     
     
         7 . The pharmaceutical formulation of  claim 6 , further comprising amoxicillin. 
     
     
         8 . The pharmaceutical formulation of  claim 6 , wherein said at least one pharmaceutically acceptable excipient is selected from the group consisting of microcrystalline cellulose and silica. 
     
     
         9 . A pharmaceutical dosage form comprising a pharmaceutical formulation of  claim 6 . 
     
     
         10 . The composition of  claim 2 , further comprising amoxicillin. 
     
     
         11 . The composition of  claim 2 , further comprising at least one excipient. 
     
     
         12 . The composition of  claim 11 , wherein said at least one excipient is selected from the group consisting of microcrystalline cellulose and silica. 
     
     
         13 . A pharmaceutical formulation comprising the composition of  claim 2  and at least one pharmaceutically acceptable excipient. 
     
     
         14 . The pharmaceutical formulation of  claim 13 , further comprising amoxicillin. 
     
     
         15 . The pharmaceutical formulation of  claim 13 , wherein said at least one pharmaceutically acceptable excipient is selected from the group consisting of microcrystalline cellulose and silica. 
     
     
         16 . A pharmaceutical dosage form comprising a pharmaceutical formulation of  claim 13 .