Galenic formulations of organic compounds
AssigneeNovartis AG
InventorsPetra Gisela Rigassi-Dietrich, Martin Schmid
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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.
Claims3
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.
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 AUC0-96 of aliskiren of about 3240 ng h/mL after administration of a single dosage.
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 AUC0-96 of aliskiren is within the range of 80% to 120% of about 3240 ng·h/mL.
Dependencies are inferred from the claim text.