Composition comprising a benzimidazole and process for its manufacture
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;
(b) an intermediate layer; and
(c) an enteric layer; wherein the core consists essentially of, by weight:
about 15 to about 60 parts of pantoprazole sodium,
about 30 to about 60 parts of lactose,
about 30 to about 60 parts of cellulose acetate,
about 15 to about 30 parts of a disintegrant, and
about 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.
2. The composition of claim 1 , wherein the disintegrant comprises cross-linked polyvinylpyrrolidone.
3. The composition of claim 1 , provided either in a single tablet form or in the form of micro-tablets enclosed inside a capsule.
4. The composition of claim 1 , wherein the lubricant comprises sodium stearylfumarate, magnesium stearate, talc, glyceryl behenate or a mixture thereof.
5. The composition of claim 1 , wherein the core further comprises a filler, plastifier, surfactant, pigment, wetting agent, or mixture thereof.
6. The composition of claim 1 , wherein the core additionally comprises at least one further excipient that is other than a binder.
7. The composition of claim 1 , wherein the sodium salt of pantoprazole comprises pantoprazole sodium sesquihydrate.