Delayed release formulations containing 3 - (3-dimethylamine-1-ethyl-2-methyl-propyl) phenol or a pharmaceutically acceptable phenolic salt and oral tablets

摘要

A delayed release pharmaceutical preparation containing 3 - (3-dimethylamine-1-ethyl-2-methyl-propyl) phenol or a pharmaceutically acceptable phenyl salt, contained in the delayed release matrix of the active substance, Tables 1 to 80 contain one or more hydrofluoroalkane or hydrofluoroalkane polymers by weight as an acceptable matrix for the drug and show the next release rate measured by the paddle p method in a test tubeh. Eur. At 75 revolutions / min. in a buffer according to Ph. Eur. at pH 6.8 at 37 ° C with UV spectrometry detection. 3-35% by weight (based on 100% by weight of active substance) of 3- (3-dimethylamino-1-ethyl-2-methyl-propyl) phenol released after 0.5 hours5-50% by weight of 3- (3-dimethylamino-2-ethyl-2-methyl-propyl) phenol released after 1 hour, 10-75% by weight of 3- (3-dimethylamino-1-ethyl-2 -methyl-propyl) phenol released after 2 hours, 15-82% by weight of 3- (3-dimethylamino-1-ethyl-2-methyl-propyl) phenol released after 3 hours, 30-97% by weight of 3- (3-Dimethylamino-1-ethyl-2-methyl-propyl) phenol released after 6 hours, more than 50% by weight of 3- (3-dimethylamino-1-ethyl-2-methyl-propyl-phenol released after 12 hours, more than 70% by weight of 3- (3-dimethylamino-1-ethyl-2-methyl-propyl) phenol released after 18 hours, more than 80% by weight of 3- (3-dimethylamino- 1-ethyl-2-methyl-propyl) phenol released after 24 hours.