Sodium Ibuprofen Tablets and Methods of Manufacturing Pharmaceutical Compositions Including Sodium Ibuprofen
AssigneeWyeth
InventorsJeffery Jon Seyer, Amy Lee Conder, Angela Pearce Taylor, Bonny Rene Shaw
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Abstract
Sodium ibuprofen compositions and methods of manufacturing tablets and caplets comprising sodium ibuprofen are described. The formulation is advantageous because it allows for the formation of tablets having low sodium content and further provides tablets exhibiting improved physical stability, high tablet hardness and high strength, coupled with excellent dissolution and bioavailability characteristics. The formulations and processes are further advantageous because they can be produced in large quantities without an unacceptable number of defective tablets,
Claims9
A method of providing ibuprofen to a human seeking relief from pain, the method comprising administering to the human a pharmaceutical composition having a core comprising:
- a granulate comprising sodium ibuprofen dihydrate;
- a binder comprising mannitol, lactose or a combination thereof;
- and a glidant;
- and
- a compression mix comprising mannitol, lactose or a combination thereof;
- microcrystalline cellulose;
- a glidant;
- and a lubricant;
- wherein the core is free of inorganic salts, the composition has a hardness greater than 80 N and has a sodium content of less than 23 mg per dosage unit.
Dependencies are inferred from the claim text.