26-09-2013 дата публикации
Номер: US20130251791A1
Принадлежит:
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. 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; about 10 to about 80 parts of a benzimidazole active ingredient in an alkaline salt form,', 'about 20 to about 85 parts of a first, water-soluble, diluent,', '0 to about 80 parts of a second, water-insoluble, diluent,', 'about 10 to about 40 parts of a disintegrant, and', '0 to about 5 parts of a lubricant., 'wherein the core consists essentially of, by weight2. The composition of claim 1 , wherein the second claim 1 , water-insoluble claim 1 , diluent is present in an amount up to about 80 parts claim 1 , by weight.3. The composition of claim 2 , wherein the core consists essentially of claim 2 , by weight:about 15 to about 60 parts of said benzimidazole active ingredient,about 40 to about 75 parts of the first, water-soluble, diluent,up to about 40 parts of the second, water-insoluble, diluent,about 15 to about 30 parts of the disintegrant, andabout 0.5 to about 5 parts of the lubricant.4. The composition of claim 2 , wherein the first diluent and the second diluent are present in a weight ratio of about 1.5:1 to 1:1.5.5. The composition of claim 2 , wherein the first claim 2 , water-soluble claim 2 , diluent comprises lactose and the second claim 2 , water-insoluble claim 2 , diluent comprises cellulose acetate.6. The composition of claim 2 , wherein the disintegrant comprises cross-linked polyvinylpyrrolidone.7. The composition of claim 1 , wherein the core consists essentially of claim 1 , by weight:about 15 to about 60 parts of said benzimidazole active ingredient,about 40 to about 75 ...
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