Modified release ibuprofen dosage form

A modified release tablet, comprising:

• ibuprofen in an amount in the range of 300 mg to 800 mg per tablet;
• a hydrophilic polymer;
• a dissolution additive at a concentration of from 10% to 35% by weight of the ibuprofen comprising alkali metal salts, an amino acid possessing neutral-to-alkaline side chain, croscarmellose or a salt thereof or a combination thereof;
• and
• an inert formulation additive comprising microcrystalline cellulose, silicified microcrystalline cellulose, dicalcium phosphate, lactose, pre-gelatinized starch or mixtures thereof, said inert formulation additive being present in said dosage in an amount of 15% to about 75% by weight of the ibuprofen,
• wherein said tablet demonstrates a mean serum ibuprofen concentration in a subject greater than or equal to 6.4 μg/ml within two hours of administration, and wherein said tablet also demonstrates a mean serum ibuprofen concentration in a subject greater than or equal to 6.4 μg/ml for at least 8 hours after administration.

The method for providing immediate and extended release of ibuprofen to a subject, comprising:

• administering to a subject in a single dose of a modified release tablet comprising,
• ibuprofen in an amount in the range of 300 mg to 800 mg per tablet;
• a hydrophilic polymer;
• a dissolution additive at a concentration of from 10% to 35% by weight of the ibuprofen comprising alkali metal salts, an amino acid possessing neutral-to-alkaline side chain, croscarmellose or a salt thereof or a combination thereof;
• and
• an inert formulation additive comprising microcrystalline cellulose, silicified microcrystalline cellulose, dicalcium phosphate, lactose, pre-gelatinized starch or mixtures thereof, said inert formulation additive being present in said dosage in an amount of 15% to about 75% by weight of the ibuprofen,
• wherein said tablet demonstrates a mean serum ibuprofen concentration in a subject greater than or equal to 6.4 μg/ml within two hours of administration, and wherein said tablet also demonstrates a mean serum ibuprofen concentration in a subject greater than or equal to 6.4 μg/ml for at least 8 hours after administration.