Bupropion hydrobromide and therapeutic applications

  • US 7,645,802 B2
  • Filed: 10/31/2007
  • Issued: 01/12/2010
  • Est. Priority Date: 06/27/2005
  • Status: Active Grant
First Claim
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1. A modified release bupropion hydrobromide composition comprising:

  • a core comprising a therapeutically effective amount of bupropion hydrobromide; and

    a controlled release polymeric coat comprising from about 1% to about 12% by weight of tablet dry weight of a water-insoluble polymer and from about 1.5% to about 10% by weight of tablet dry weight of a water-soluble polymer;

    wherein said coat at least partially surrounds said core; and

    wherein said composition releases bupropion hydrobromide in a first dissolution medium consisting of 0.1 N HCl and 5%-40% v/v ethanol at a rate that is less than or equal to about 1.1 times the rate of release of bupropion hydrobromide from an identical modified release pharmaceutical composition in a second dissolution medium consisting of 0.1 N HCl, measured over a time period of at least from 0 to 2 hours measured using a USP Apparatus I at 75 rpm and at 37±

    0.5°

    C.

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