Modified release ibuprofen dosage form

Abstract

The present invention is a solid dosage form for oral administration of ibuprofen comprising a modified release formulation of ibuprofen which provides an immediate burst effect and thereafter a sustained release of sufficient ibuprofen to maintain blood levels at least 6.4 g/ml over an extended period of at least 8 hours following administration of a single dose. The dosage form releases ibuprofen at a rate sufficient to initially deliver a effective amount of ibuprofen within about 2.0 hours following administration. The dosage form then subsequently delivers the remaining amount of ibuprofen at a relatively constant rate sufficient to maintain a level of ibuprofen over a predetermined delivery period of for at least 8 hours.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application Nos. 60 / 614,932, filed September 30, 2004, and U.S. Provisional Application No. 60 / 689,631, filed June 10, 2005, and U.S. Nonprovisional Application (Application number to be assigned) priority. Background technique [0003] Ibuprofen is 2-(4-isobutylphenyl)propionic acid, a non-steroidal anti-inflammatory compound (NSAID), which is effective in the treatment of rheumatoid arthritis, osteoarthritis and other inflammatory High levels of anti-inflammatory, analgesic and antipyretic activity necessary for the disorder. Most dosage forms of ibuprofen are immediate release dosage forms, which rapidly exert their therapeutic effect, and then the level of active ingredient drops rapidly, so repeated dosing is required. They do not maintain therapeutic levels at one dose for extended periods of time. Therefore, repeated administration is required every 4 to 6 hours. Formul...

AI Technical Summary

Problems solved by technology

Formulations that claim extended release do not initially produce a burst of drug, thus presenting a substantial delay between dosing and achieving therapeutically effective blood levels

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