abstract |
This invention relates to an oral modified release multi-unit oral pharmaceutical composition for administering a therapeutically and / or prophylactically effective amount of a non-steroidal anti-inflammatory drug substance (hereinafter abbreviated as “NSAID substance”) to obtain both a relatively rapid or rapid therapeutic effect and maintain a therapeutically active concentration in plasma for a relatively long period of time. The multi-unit modified release composition contains at least two fractions of multiple units, such as the first and second fractions. The first fraction contains individual units that are designed for the rapid release of the drug substance, and the second fraction contains individual units that are designed for the slow release of the drug substance. Typically, the second fraction contains multiple units that are coated with a sustained release coating designed to release the drug substance in such a way that it maintains a therapeutically active plasma concentration for a relatively long period of time. By appropriately adjusting the release pattern of at least the first and second fractions, a composition is prepared that is adapted to be administered once or twice a day. |