Crystalline composition containing escitalopram

Abstract

Crystalline particles of escitalopram oxalate with a particle size of at least 40 μm is disclosed. Method for the manufacture of said crystalline particles and pharmaceutical compositions comprising said crystalline particles are also disclosed.

1 . Crystalline particles of escitalopram oxalate having a median particle size of at least 40 ÿm. 
   
   
       2 . The crystalline particles of  claim 1  wherein the median particle size is from 50-200 ÿm. 
   
   
       3 . A method for the manufacture of crystalline particles of escitalopram oxalate, which comprises
 (a) dissolving escitalopram oxalate in a solvent at a first temperature between about 50° C. and the refluxing temperature of the solvent to form a solution of escitalopram oxalate;   (b) gradually cooling the solution of escitalopram oxalate to a second temperature between about 0° C. and 20° C. while maintaining a controlled cooling rate;   (c) adding crystals of escitalopram oxalate during the cooling of step (b);   (d) holding the solution at the second temperature; and   (e) isolating crystalline particles of escitalopram oxalate from the solution.   
   
   
       4 - 29 . (canceled) 
   
   
       30 . A solid unit dosage form comprising the crystalline particles of escitalopram oxalate of  claim 1 . 
   
   
       31 . A solid unit dosage form comprising the crystalline particles of escitalopram oxalate of  claim 2 . 
   
   
       32 . The solid unit dosage form of  claim 30 , which comprises a tablet prepared by direct compression of a mixture of escitalopram oxalate and pharmaceutically acceptable excipients. 
   
   
       33 . The solid unit dosage form of  claim 32 , wherein the tablet is coated. 
   
   
       34 . The solid unit dosage form of  claim 30 , which is prepared by filling a hard gelatin capsule with a mixture of escitalopram oxalate and pharmaceutically acceptable excipients. 
   
   
       35 . The solid unit dosage form of  claim 30 , which does not contain a binder. 
   
   
       36 . The solid unit dosage form of  claim 30 , which comprises 1-30% w/w active ingredient calculated as escitalopram base. 
   
   
       37 . The solid unit dosage form of  claim 30 , which comprises 4-20% w/w active ingredient calculated as escitalopram base. 
   
   
       38 . The solid unit dosage form of  claim 30 , which comprises 6-10% w/w active ingredient calculated as escitalopram base. 
   
   
       39 . The solid unit dosage form of  claim 30 , which further comprises a filler selected from the group consisting of lactose, sugars, calcium phosphates, starch, modified starches, microcrystalline cellulose, calcium sulfate and calcium carbonate. 
   
   
       40 - 50 . (canceled) 
   
   
       51 . The solid unit dosage form of  claim 30 , which is substantially free of lactose.