Stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof

Abstract

Provided are formulations of a stable commercial paroxetine tablet comprising paroxetine hydrochloride anhydrous, povidone, copovidone or HPMC as a binder, and an HCl free/non-hygroscopic filler, prepared by the wet granulation method.

1 - 92 . (canceled)  
     
     
         93 . A paroxetine hydrochloride anhydrous tablet prepared by wet granulation comprising an effective amount of povidone as a binder.  
     
     
         94 . The tablet of  claim 93 , wherein the ratio of povidone to paroxetine hydrochloride is about 20% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         95 . The tablet of  claim 94 , wherein the ratio is about 30% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         96 . The tablet of  claim 95 , wherein the ratio is about 35% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         97 . A paroxetine hydrochloride anhydrous tablet comprising povidone as a binder.  
     
     
         98 . The tablet of  claim 97 , wherein the ratio of povidone to paroxetine hydrochloride is about 20% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         99 . The tablet of  claim 98 , wherein the ratio is about 30% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         100 . The tablet of  claim 99 , wherein the ratio is about 35% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         101 . A granule prepared by wet granulation of paroxetine hydrochloride anhydrous and povidone as a binder.  
     
     
         102 . The granule of  claim 101 , wherein the ratio of povidone to paroxetine hydrochloride is from about 20% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         103 . The granule of  claim 102 , wherein the ratio is from about 30% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         104 . The granule of  claim 103 , wherein the ratio is from about 35% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         105 . The granule of  claim 101 , wherein the granule has an LOD-NMT of less than about 1%.  
     
     
         106 . A process for preparing a stable paroxetine hydrochloride anhydrous tablet comprising the steps of: 
 a. granulating in a wet environment paroxetine hydrochloride anhydrous and one or more excipients to obtain a granule, wherein one excipient is povidone;    b. drying the granule;    c. preparing a final blend from the granule; and    d. compressing the final blend.    
     
     
         107 . The process of  claim 106 , wherein the ratio of povidone to paroxetine hydrochloride is about 20% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         108 . The process of  claim 107 , wherein the ratio is about 30% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         109 . The process of  claim 108 , wherein the ratio is about 35% to about 40% weight to weight of povidone to paroxetine hydrochloride.  
     
     
         110 . The process of  claim 106 , wherein the granules are dried to an LOD-NMT of about 1%.  
     
     
         111 . The process of  claim 106 , further comprising coating the compressed final blend.  
     
     
         112 . The process of  claim 117 , wherein opadry is used for coating.  
     
     
         113 . The process of  claim 112 , wherein the excipients used during wet granulation are selected from the group consisting of a disintegrant and a filler.  
     
     
         114 . The process of  claim 119 , wherein the filler is dibasic calcium phosphate anhydrous.  
     
     
         115 . The process of  claim 119 , wherein the disintegrant is sodium starch glycolate.  
     
     
         116 . The process of  claim 112 , wherein the blend is prepared by addition of a lubricant.  
     
     
         117 . The process of  claim 122 , wherein the lubricant is magnesium stearate.  
     
     
         118 . The process of  claim 112 , wherein the wet environment consists essentially of water.  
     
     
         119 . The process of claim  124 , wherein the wet environment consists of purified water.  
     
     
         120 . A paroxetine hydrochloride anhydrous tablet prepared by wet granulation comprising an effective amount of co-povidone as a binder.  
     
     
         121 . A paroxetine hydrochloride anhydrous tablet comprising co-povidone as a binder.  
     
     
         122 . A process for preparing a stable paroxetine hydrochloride anhydrous tablet comprising the steps of: 
 a. granulating in a wet environment paroxetine hydrochloride anhydrous and one or more excipients to obtain a granule, wherein one excipient is co-povidone;    b. drying the granule;    c. preparing a final blend from the granule; and    d. compressing the final blend.