| 摘要 |
Delayed release pharmaceutical formulations (A) comprise 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol (I) in a delayed release matrix containing 1-80 wt. % hydrophilic or hydrophobic polymer(s) (II) as matrix former; and have a specific in vitro (I) release profile over 24 hours and/or contain a cellulose ether and/or cellulose ester. Delayed release pharmaceutical formulations (A) comprise 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol (I) (or its salt) in a delayed release matrix containing 1-80 wt. % hydrophilic or hydrophobic polymer(s) (II) as matrix former; where: (i) (A) have an in vitro (I) release profile (measured by the European Pharmacopoiea paddle method, under stirring at 75 rpm in buffer of pH 6.8 at 37 degreesC and UV-spectroscopic detection) of 3-35 wt. % (I) released after 0.5 hour, 5-50 wt. % after 1 hour, 10-75 wt. % after 2 hours, 15-82 wt. % after 3 hours, 30-97 wt. % after 6 hours, more than 50 wt. % after 12 hours, more than 70 wt. % after 18 hours and more than 80 wt. % after 24 hours; and/or (ii) (A) contain a cellulose ether and/or cellulose ester having a viscosity of 3000-150000 mPa.s in 2 wt. % aqueous solution at 20 degreesC as (II). An Independent claim is included for (A)-containing tablets for twice-daily oral administration of (I).
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