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Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof

  • US 7,695,734 B2
  • Filed: 08/12/2005
  • Issued: 04/13/2010
  • Est. Priority Date: 08/13/2004
  • Status: Active Grant
First Claim
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1. An extended release tablet formulation comprising pramipexole or a pharmaceutically acceptable salt thereof in a matrix comprising at least two water swelling hydrophilic polymers other than pregelatinized starch, and wherein at least one of the at least two polymers is an anionic polymer and the other is a substantially neutral polymer, and wherein the formulation does not contain pregelatinized starch, the resulting tablet formulation providing a pH-dependent release rate in the range of pH<

  • 4.5, and a pH-independent release rate in the range from pH 4.5 to 7.5, wherein the release rate in the range of pH<

    4.5 is higher than the release rate in the range from pH 4.5 to 7.5, when the formulation is tested in the following pH media;

    simulated gastric juice at pH 1.2, McIlvaine buffer at pH 4.5 and phosphate buffer at pH 6.8, wherein the content of the anionic polymer is from about 0.5 wt.-% to about 15 wt.-% and the content of the substantially neutral polymer is from about 25 wt.-% to about 65 wt.-%.

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