Galenic formulations of organic compounds
AssigneeNovartis AG
InventorsPetra G 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.
Claims20
A solid oral dosage form comprising a therapeutically effective amount of aliskiren, or a pharmaceutically acceptable salt thereof, in an amount of more than 46% by weight based on the total weight of the oral dosage form, wherein the oral dosage form is in the form of a tablet and comprises a) an inner phase which is comprising aliskiren or a pharmaceutically acceptable salt thereof, microcrystalline cellulose, polyvinylpyrrolidone, and crosslinked polyvinylpyrrolidone, and b) an outer phase which is comprising crosslinked polyvinylpyrrolidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate and wherein the amount of microcrystalline cellulose in the dosage form ranges from 20 to 32% by weight, the amount of crosslinked polyvinylpyrrolidone in the dosage form ranges from 13.5 to 16% by weight, the amount of polyvinylpyrrolidone in the dosage form ranges from 3 to 4% by weight, the amount of colloidal silicon dioxide in the dosage form ranges from 0.4 to 0.6% by weight, and the amount of magnesium stearate in the dosage form ranges from 0.2 up to 5% by weight.
Dependencies are inferred from the claim text.