G.L. Pharma GmbH;Alfred E. Tiefenbacher (GmbH & Co. KG)
发明人:
申请号：
EP14167733.6
公开号：
EP2942054A1
申请日:
2014.05.09
申请国别(地区):
EP
年份:
2015
代理人:
摘要：
The present invention relates to a slow-release pharmaceutical formulation containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol or a pharmaceutically acceptable salt thereof as active ingredient in a slow release matrix, wherein the matrix contains between 15 and 50 wt.-% of mono-, di-and triglycerides of saturated fatty acids with a chain length between 16 and 22 carbon atoms and a mixture of such mono-, di- und triglycerides, respectively, as pharmaceutically acceptable matrix forming agents, is free of polymers as matrix forming agents and has the following release rate in vitro, measured by the Ph. Eur. Paddle Method at 100 rpm in a buffer (to Ph. Eur.) at a pH of 6.8 at 37° C and detected using a UV spectrometer:3 to 35 % by weight (based on 100% by weight active ingredient) 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 0.5 hours,5 to 50% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 1 hour,10 to 75% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 2 hours,15 to 82% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 3 hours,30 to 97% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 6 hours,more than 50% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 12 hours,more than 70% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 18 hours, andmore than 80% by weight 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol released after 24 hours,as well as to a tablet for twice-daily oral administration of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol, containing such a pharmaceutical formulation.
