Loading patent…
AssigneeForest Laboratories Holdings Limited
InventorsYan YANG, Rajiv JANJIKHEL, Niranjan RAO, Antonia PERICLOU, Wattanaporn ABRAMOWITZ, Mahendra G. DEDHIYA, Erhard SEILLER, Bernhard HAUPTMEIER
Estimating the term…
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.
An immediate release solid oral dosage form comprising (i) an active ingredient selected from the group consisting of neramexane, optical isomers, diastereomers, enantiomers, hydrates, and pharmaceutically acceptable salts thereof, (ii) a pharmaceutically acceptable filler selected from microcrystalline cellulose, wherein the microcrystalline cellulose is present in a range from 20% w/w to 95% w/w, and (iii) a disintegrant, said dosage form exhibiting dose-proportionality and releasing said active ingredient at a rate of more than about 80% within about the first 60 minutes following entry of said form into a use environment, wherein said dosage form 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, and wherein said dosage form is free of lactose.
Dependencies are inferred from the claim text.