Directly compressible formulations of azithromycin

Abstract

The present invention relates to a dry blend, used for forming azithromycin tablets by direct compression, comprising non-dihydrate azithromycin and at least one pharmaceutically acceptable excipient. This invention also relates to an azithromycin tablet comprising non-dihydrate azithromycin and at least one pharmaceutically acceptable excipient. Preferably, the azithromycin tablet is formed by directly compressing the dry blend, of the present invention, to form said azithromycin tablet. Preferably, the azithromycin tablet, of the present invention, contains a dosage of 250 mgA, 500 mgA or 600 mgA of azithromycin. This invention further relates to an azithromycin tablet which is produced by forming a dry blend of a non-granulated azithromycin form A and at least one pharmaceutically acceptable excipient. The azithromycin tablet is then formed by directly compressing the dry blend.

1 . A dry blend, used for forming azithromycin tablets by direct compression, comprising: 
 (a) about 1-80%, by weight non-dihydrate azithromycin; and    (b) at least one pharmaceutically acceptable excipient;    wherein the Carr's Compressibility Index, of the dry blend, is less than about 34%; wherein said non-dihydrate azithromycin is azithromycin monohydrate hemi-ethanol solvate, azithromycin monohydrate hemi-isopropanol solvate, azithromycin monohydrate hemi-n-propanol solvate or azithromycin sesquihydrate.    
   
   
       2 - 4 . (canceled)  
   
   
       5 . A dry blend of  claim 1  wherein the non-dihydrate azithromycin is non-granulated.  
   
   
       6 . (canceled)  
   
   
       7 . A dry blend of  claim 1  further comprising about 0. 1-85%, by weight, of a diluent.  
   
   
       8 . A dry blend of  claim 7  wherein said diluent is from 20-70%, by weight.  
   
   
       9 - 10 . (canceled)  
   
   
       11 . A dry blend of  claim 8  wherein the Carr's Compressibility Index, of the dry blend, is less than about 31%.  
   
   
       12 . A dry blend of  claim 8  wherein the Carr's Compressibility Index, of the dry blend, is less than about 28%.  
   
   
       13 . A dry blend of  claim 1  further comprising from about 2-15%, by weight, of a disintegrant.  
   
   
       14 . A dry blend of  claim 13  further comprising: 
 (a) about 2-10%, by weight, of the disintegrant; and    (b) about 0.5-8%, by weight, of a lubricant.    
   
   
       15 . A dry blend of  claim 1  further comprising from about 0.25-10%, by weight, of a lubricant.  
   
   
       16 . A dry blend of  claim 15  wherein said lubricant is from about 0.5-3%, by weight.  
   
   
       17 - 24 . (canceled)  
   
   
       25 . A dry blend of  claim 1  wherein the Carr's Compressibility Index, of the dry blend, is less than about 31%.  
   
   
       26 . A dry blend of  claim 1  wherein the Carr's Compressibility Index, of the dry blend, is less than about 28%.  
   
   
       27 . A dry blend of  claim 1  wherein the internal angle of friction, of the dry blend, is less than about 34°.  
   
   
       28 . (canceled)  
   
   
       29 . A dry blend of  claim 1  wherein the internal angle of friction, of the dry blend, is less than about 31°.  
   
   
       30 - 83 . (canceled)  
   
   
       84 . A directly compressible dry blend comprising: 
 (a) azithromycin monohydrate hemi-ethanol solvate, azithromycin monohydrate hemi-isopropanol solvate, azithromycin monohydrate hemi-n-propanol solvate or azithromycin sesquihydrate; and    (b) at least one pharmaceutically acceptable excipient;    
   
   
       85 . The dry blend of  claim 84  wherein the Carr's Compressibility Index, of the dry blend, is less than about 34%.