Controlled release dosage forms

  • US 7,780,987 B2
  • Filed: 02/21/2003
  • Issued: 08/24/2010
  • Est. Priority Date: 02/21/2002
  • Status: Active Grant
First Claim
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1. A pharmaceutical oral dosage form comprising an oral dosage form coated with a stable controlled release monolithic coating, wherein the stable controlled release monolithic coating is applied onto the oral dosage form by a process comprisingcoating the oral dosage form with a coating composition to form a coated oral dosage form, andcuring the coated oral dosage form at a temperature of at least 55°

  • C. to form the stable controlled release monolithic coating,wherein the coating composition consists essentially ofa neutral ester copolymer in an amount of from about 1% to about 35% by weight of the coating composition based on ethyl acrylate and methyl acrylate selected from the group consisting of a 30% aqueous dispersion of a neutral ester copolymer based on ethyl acrylate and methyl methacrylate, a 40% aqueous dispersion of a neutral ester copolymer based on ethyl acryl ate and methyl methacrylate, and combinations thereof;

    a polyethylene glycol selected from the group consisting of polyethylene glycol 6000, polyethylene glycol 8000, polyethylene glycol 10000, polyethylene glycol 20000, and combinations thereof in an amount of from about 0.1% to about 3% by weight of the coating composition; and

    one or more of a hydrophilic agent, and a pharmaceutically acceptable excipient.

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