Tofacitinib oral sustained release dosage forms

  • US 9,937,181 B2
  • Filed: 03/14/2014
  • Issued: 04/10/2018
  • Est. Priority Date: 03/16/2013
  • Status: Active Grant
First Claim
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1. A once daily pharmaceutical dosage form comprisinga core comprising 11 mg of tofacitinib, or an equivalent amount of tofacitinib in the form of a pharmaceutically acceptable salt thereof, and an osmagen,and a semi-permeable membrane coating surrounding the core wherein said coating comprises a water-insoluble polymer,wherein said dosage form is a sustained release dosage form, and when added to a test medium comprising 900 ml of 0.05M pH 6.8 potassium phosphate buffer at 37°

  • C. in a standard USP rotating paddle apparatus and the paddles are rotated at 50 rpm, dissolves not more than 30% of the tofacitinib, or pharmaceutically acceptable salt thereof, in 1 hour, and not less than 35% and not more than 75% of the tofacitinib, or pharmaceutically acceptable salt thereof, in 2.5 hours and not less than 75% of the tofacitinib, or pharmaceutically acceptable salt thereof, in 5 hours and wherein said dosage form delivers the tofacitinib, or pharmaceutically acceptable salt thereof, to a subject primarily by osmotic pressure and wherein the water-insoluble polymer is a cellulose derivative that sustains release of the tofacitinib, or pharmaceutically acceptable salt thereof.

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