Immediate release formulations of 1-aminocyclohexane compounds, memantine and neramexane
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United States of America Patent
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Issued Date -
Jan 5, 2006
app pub date -
Jun 16, 2005
filing date -
Jun 17, 2004
priority date (Note) -
Abandoned
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Abstract
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 T.sub.max 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 T.sub.max.
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