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US 6,855,336 B2Granted
Omeprazole formulation
AssigneeAndrx Pharmaceuticals, Inc.
InventorsChih-Ming Chen, Joseph Chou, Unchalee Kositprapa
Life of this patent
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Abstract
A stable pharmaceutical composition of omeprazole for oral administration which consists essentially of: (a) a core of Omeprazole or a pharmaceutically equivalent salt, a filler and an alkaline material selected from the group consisting of lysing and arginine; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent which is applied from an organic solvent based system.
Claims6
A method for preparing a stable oral pharmaceutical dosage formulation which consists of:
- (a) forming a pellet core consists of 10 to 50 weight percent based on the total weight of the core of omeprazole or a pharmaceutically acceptable salt, a surface active agent, a filler, a binder and 0.5 to 10 weight percent based on the total weight of the core of a pharmaceutically acceptable alkaline agent, wherein the alkaline agent is selected from the group consisting of lysine and arginine;
- and
- (b) applying an enteric coating directly onto the core without a separating layer wherein the enteric coating layer surrounds the core and consisting essentially of an enteric coating agent, 5 to 50 weight percent based on the total weight of the coating layer of an inert processing aid and optionally a plasticizer.
Dependencies are inferred from the claim text.