Nycomed Danmark Aps

Niels Gjørløv Hansen

Hermann Ruckendorfer

Shigeru Itai

The present invention relates to an oral modified release pharmaceutical composition for the administration of a therapeutically and/or prophylactically effective amount of an active substance (a drug substance) to obtain a relatively fast or quick onset of the therapeutic and/or prophylactic effect. The drug substances contained in a modified release pharmaceutical composition according to the invention are suitably a drug substance which has a very low solubitity under acidic conditions, i.e. under conditions similar to those present in the stomach and/or drug substances which have a pKvalue below about 5.5 such as in a range of from about 4 to about 5. The composition is based on a powder comprising a therapeutically and/or prophylactically active substance and has such a particle size that: when the powder is subjected to a sieve analysis, then at least about 90% w/w of the particles passes through sieves 180 &#x3bc;m and the powder is contacted with an aqueous medium to form a particulate composition, which has such a particle size that when the particulate composition is subjected to a sieve analysis, then at least about 50% w/w of the particles passes through sieve 180 &#x3bc;m. Furthermore, the composition, when tested in accordance with the dissolution method (I) defined herein employing 0.07 N hydrochloric acid as dissolution medium, releases at least about 50% w/w of the active substance within the first 20 min of the test.

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Fredericksberg, Denmark

Niels Gjørløv Hansen