|Title:||Galenic formulations of organic compounds|
|Abstract:||The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, and wherein the active ingredient is present in an amount of more than 46% by weight based on the total weight of the oral dosage form.|
|Inventor(s):||Rigassi-Dietrich; Petra Gisela (Therwil, CH), Schmid; Martin (Wettingen, CH)|
|Assignee:||Novartis AG (Basel, CH)|
|Filing Date:||Apr 29, 2005|
|Claims:||1. A solid oral dosage form comprising aliskiren hemi-fumarate salt present in an amount of about 663 mg per dosage, said dosage form providing a mean maximum plasma concentration of aliskiren of about 420 ng/mL a median of about 2 hours after administration of a single dosage. |
2. A solid oral dosage form comprising aliskiren hemi-fumarate salt present in an amount of about 663 mg per dosage, said dosage form providing a mean AUC.sub.0-96 of aliskiren of about 3240 ng h/mL after administration of a single dosage.
3. A solid oral dosage form comprising about 663 mg of aliskiren in the form of a hemi-fumarate salt, and a carrier medium, said dosage form providing a mean maximum plasma concentration of aliskiren within the range of 80% to 120% of about 420 ng/mL a median of about 2 hours after administration of a single dosage, whereby a mean AUC.sub.0-96 of aliskiren is within the range of 80% to 120% of about 3240 ngh/mL.
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