Composition comprising a benzimidazole and process for its manufacture

Abstract

The invention provides new benzimidazole compositions, comprising: (a) a core containing said benzimidazole active ingredient; (b) an intermediate layer; and (c) an enteric layer; said core being substantially free of binder. The invention also provides a process for manufacturing the composition of the invention.

1 .- 44 . (canceled) 
     
     
         45 . A pharmaceutical composition comprising:
 (a) a core that is free of binder and free of PVP as a binder and/or HPMC;   (b) an intermediate layer; and   (c) an enteric layer;   wherein the core consists essentially of, by weight:
 about 15 to 60 parts of rabeprazole sodium, 
 about 30 to 60 parts of lactose, 
 about 30 to 60 parts of cellulose acetate, 
 about 15 to 30 parts of a disintegrant, and 0.5 to about 5 parts of a lubricant, 
   and wherein the lactose and the cellulose acetate are present in a weight ratio of about 1.5:1 to 1:1.5.   
     
     
         46 . The composition of  claim 45 , wherein the disintegrant comprises cross-linked polyvinylpyrrolidone. 
     
     
         47 . The composition of  claim 45 , provided either in a single tablet form or in the form of micro-tablets enclosed inside a capsule. 
     
     
         48 . The composition of  claim 45 , wherein the lubricant comprises sodium stearylfumarate, magnesium stearate, talc, glyceryl behenate, or a mixture thereof 
     
     
         49 . The composition of  claim 45 , wherein the core further comprises a filler, plastifier, surfactant, pigment, wetting agent, or mixture thereof. 
     
     
         50 . The composition of  claim 45 , wherein the core additionally comprises at least one further excipient that is other than a binder.