Crystalline amoxicillin trihydrate powder

Abstract

The invention relates to crystalline amoxicillin trihydrate powder having a bulk density higher than 0.45 g/ml. The invention also relates to a process for preparing crystalline amoxicillin trihydrate powder, said process comprising: crystallizing amoxicillin trihydrate from a solution containing dissolved amoxicillin; separating the crystals from said solution; and drying the separated crystals, resulting in crystalline powder having a bulk density higher than 0.45 g/ml.

1 - 20 . (canceled) 
   
   
       21 . Process for preparing crystalline amoxicillin trihydrate powder having a bulk density higher than 0.45 g/ml and a d 50  lower than 100 μm, said process comprising:
 resulting in crystalline powder having a bulk density higher than 0.45 g/ml, and a d 50  lower than 100 μm.   
   
   
       22 . Process according to  claim 21 , resulting in crystalline powder having a tapped density higher than 0.6 g/ml, wherein said tapped density is determined according to USP 24, method II. 
   
   
       23 . Process according to  claim 21 , resulting in crystalline powder having a d 50  higher than 10 μm. 
   
   
       24 . Process according to  claim 21 , resulting in crystalline powder having a d 10  higher than 3 μm. 
   
   
       25 . Process according to  claim 21 , wherein the process comprises mechanically impacting the crystals during said drying. 
   
   
       26 . Process according to  claim 21 , wherein the process comprises:
 preparing amoxicillin by reacting 6-amino-penicillanic acid or a salt thereof, with para-hydroxyphenyl glycine in activated form in the presence of an enzyme immobilized on a carrier;   forming an aqueous solution containing the amoxicillin, said aqueous solution containing hydrochloric acid; and   crystallizing amoxicillin trihydrate from said aqueous solution.   
   
   
       27 . Process according to  claim 21 , wherein the aqueous solution from which the amoxicillin is crystallized has an amoxicillin concentration of less than 0.6 mol/l. 
   
   
       28 . Process according to  claim 21 , wherein the solution from which the amoxicillin is crystallized contains less than 200 weight parts of protein per 1.000.000 weight parts of the amoxicillin antibiotic in said solution.