Pharmaceutical formulation for acid-labile compounds
AssigneeAndrx Pharmaceuticals, Inc.
InventorsChih-Ming Chen, Joseph Chou, Unchalee Kositprapa
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Abstract
A pharmaceutical composition of omeprazole for oral administration is described which includes: (a) a tabletted core component containing a therapeutically effective amount of a acid-labile compound, e.g., substituted benzamidazole such as omeprazole, an optional surface active agent, a filler, a pharmaceutically acceptable alkaline agent, and a binder; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent.
Claims24
A stable pharmaceutical composition for an orally administered acid-labile compound used as an active ingredient, said composition comprising:
- (a) a tableted core comprising an uncoated granulation of a therapeutically effective amount of the active ingredient, an optional surface active agent, a pharmaceutically acceptable alkaline agent, at least one water-soluble binder, and at least one water insoluble binder;
- and
- (b) a single layer of coating on said tableted core, said coating comprising an enteric coating agent.
A pharmaceutical dosage formulation which consists essentially of:
- (a) a compressed tablet core comprising an acid-labile compound as an active ingredient, a binder, an alkaline agent, a filler and a surface active agent;
- and
- (b) an enteric coating agent around said core, said enteric coating comprising hydroxypropylmethyl cellulose phthalate and talc.
A method for manipulating bioavailability of a pharmaceutical dosage formulation comprising a core having powdered components and a coating, said method comprising the step of providing at least one water-soluble binder and at least one water-insoluble binder in the core to control cohesiveness of powdered core components upon disintegration of the core.
Dependencies are inferred from the claim text.