Galenic formulations of organic compounds

  • US 8,617,595 B2
  • Filed: 03/16/2005
  • Issued: 12/31/2013
  • Est. Priority Date: 03/17/2004
  • Status: Active Grant
First Claim
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1. 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.

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