Patent ID: 8007824

Claim:
A solid oral dosage form comprising a therapeutically effective amount of aliskiren free base, or a pharmaceutically acceptable salt thereof, and a carrier medium, wherein the oral dosage form exhibits an in vitro dissolution profile, when measured by the USP Basket Method at about 100 rpm in 500 mL of 0.01N HCI at about 37° C., such that after 10 min, from a mean of about 27% to a mean of about 56% (by weight) of aliskiren free base, or a pharmaceutically acceptable salt thereof, is released, after 15 min, from a mean of about 41% to a mean of about 77% (by weight) of aliskiren free base, or a pharmaceutically acceptable salt thereof, is released, after 20 min, from a mean of about 53% to a mean of about 94% (by weight) of aliskiren free base, or a pharmaceutically acceptable salt thereof, is released, after 30 min, from a mean of about 74% to a mean of about 100% (by weight) of aliskiren free base, or a pharmaceutically acceptable salt thereof, is released, and after 45 min, from a mean of about 94% to a mean of about 100% (by weight) of aliskiren free base, or a pharmaceutically acceptable salt thereof, is released, wherein the solid oral dosage form also comprises the following excipients in an amount by weight per unit dosage form of 20-32% microcrystalline cellulose as filler, 3-4% PVP K 30 as binder, 13.5-15% crospovidone as disintegrant, 0.4-0.6% colloidal silicon dioxide as glidant, and 0.8-1.5% magnesium stearate as lubricant.