A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/135 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2464578
The invention relates to a pharmaceutical formulation which is characterised by delayed release of the active ingredient. Said formulation contains 3-(3- dimethylamino-1-ethyl-2-methyl-propyl)phenol or one of its pharmaceutically acceptable salts in a matrix with delayed release of the active ingredient. Said matrix contains between 1 and 80 wt. % of at least one hydrophilic or hydrophobic polymer as a pharmaceutically acceptable matrix forming agent and exhibits, in vitro, the following dissolution speed: between 3 and 35 wt. % (in relation to 100 wt. % of active ingredient) of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after half an hour, between 5 and 50 wt. % of 3-(3-dimethylamino-1-ethyl-2- methyl- propyl)phenol is released after one hour, between 10 and 75 wt. % of 3-(3- dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after two hours, between 15 and 82 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after three hours, between 30 and 97 wt. % of 3-(3-dimethylamino-1-ethyl-2- methyl- propyl)phenol is released after six hours, more than 50 wt. % of 3-(3- dimethylamino- 1-ethyl-2-methyl-propyl)phenol is released after twelve hours, more than 70 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after eighteen hours, and more than 80 wt. % of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol is released after twenty-four hours.
L'invention concerne une formulation pharmaceutique à libération différée du principe actif, cette formulation contenant du 3-(3-diméthylamino-1-éthyl-2-méthyl-propyl)phénol, ou un de ses sels pharmaceutiquement acceptables, dans une matrice à libération différée du principe actif. Cette matrice contient 1 à 80 % en poids d'un ou de plusieurs polymères hydrophiles ou hydrophobes en tant qu'agents de formation de matrice pharmaceutiquement acceptables et elle présente in vitro la vitesse de dissolution suivante : 3-35 % en poids (par rapport au poids total de principe actif) de 3-(3-diméthylamino-1-éthyl-2-méthyl-propyl)phénol libérés après une demi-heure, 5-50 % en poids libérés après une heure, 10-75 % en poids libérés après deux heures, 15-82 % en poids libérés après trois heures, 30-97 % en poids libérés après quatre heures, plus de 50 % en poids libérés après douze heures, plus de 70 % en poids libérés après dix-huit heures et plus de 80 % en poids libérés après vingt-quatre heures.
Bartholomaeus Johannes
Ziegler Iris
Fetherstonhaugh & Co.
Gruenenthal Gmbh
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