Immediate release formulations of memantine oral dosage forms

Details Immediate release formulations of memantine oral dosage forms Immediate release formulations of memantine oral dosage forms

A - Human Necessities

61

K

A61K 31/13 (2006.01)

Patent

CA 2568445

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 with the range of between about 3 and 40Kp, exhibits and average T 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 of T max.

L'invention porte sur une forme de dosage oral solide à libération immédiate contenant 1-aminocyclohexanes, de préférence memantine ou neramexane, et facultativement un revêtement pharmaceutiquement acceptable, l'ingrédient actif présentant une certaine proportionnalité de dose et étant libéré à une vitesse de dissolution supérieure à environ 80 % pendant les 60 premières minutes environ après l'introduction de cette forme dans un environnement d'utilisation. La forme de dosage est directement comprimée et présente une dureté comprise entre environ 3 et 40Kp, possède un T max moyen compris entre environ 2 et 8 heures, la charge d'ingrédient actif étant comprise entre environ 2,5 et 150 mg. Ces formulations permettent d'obtenir des compositions proportionnelles en dose pour le dosage quotidien ou le dosage b.i.d., tout en conservant une moyenne constante de T max.

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