Yan Yang,Rajiv Janjikhel,Niranjan Rao,Antonia Periclou,Wattanaporn Abramowitz,Mahendra G. Dedhiya,Erhard Seiller,Bernhard Hauptmeier
申请号:
US13134467
公开号:
US08834924B2
申请日:
2011.06.08
申请国别(地区):
US
年份:
2014
代理人:
摘要:
The present invention relates to an immediate release solid oral dosage form containing 1-aminocyclohexanes, preferably memantine or neramexane, and optionally a pharmaceutically acceptable coating, wherein the active ingredient exhibits dose proportionality and is released at a dissolution rate of more than about 80% within about the first 60 minutes following entry of said form into a use environment. The dosage form is direct compressed and has a hardness within the range of between about 3 and about 40 Kp, exhibits an average Tmax within the range of about 2 to about 8 hours with an active ingredient load within the range of about 2.5 to about 150 mg. The formulation allows for dose-proportional compositions for once daily or b.i.d. dosing, while maintaining a steady average range of Tmax.