Patent ID: 9730895
Date: 2017-08-15
CPC Classifications: A61K,A61P

Claim:
1. A method for providing immediate and sustained release of ibuprofen to a subject, comprising: administering to a subject in a single dose a modified release formulation of ibuprofen comprising a hydrophilic polymer; 300 to 800 mg of ibuprofen in solid dosage form uniformly dispersed in said polymer; a dissolution additive dispersed in said hydrophilic polymer in an amount in the range of 10% to 35% by weight of the ibuprofen, said dissolution additive comprising an alkali metal salt, an amino acid having a neutral to alkaline side chain, croscarmellose sodium, or a combination thereof; and an inert formulation additive dispersed in said hydrophilic polymer in an amount in the range of 15% to 75% by weight of the ibuprofen, wherein said hydrophilic polymer comprises a first hydroxypropyl methylcellulose (HPMC) having a viscosity of about 100 cps and a second HPMC having a viscosity between about 200 cps to about 50,000 cps, wherein said formulation is in a solid dosage form comprising a monolithic tablet and releases at least 20% of the ibuprofen within 2 hours following oral administration or exposure to an agitated aqueous medium of a single dosage unit, then thereafter releases ibuprofen at a relatively constant rate in a substantially linear relationship between percentage of ibuprofen released and elapsed time over a period of at least 8 hours, and wherein at least 70% of the ibuprofen is released over a period of not more than 14 hours following such administration or exposure, and wherein said tablet demonstrates a mean ibuprofen plasma 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 ibuprofen plasma concentration in a subject greater than or equal to 6.4 μg/ml for at least 8 hours after administration.