Modified Release Dosage Forms of Skeletal Muscle Relaxants

  • US 20090017126A1
  • Filed: 09/24/2008
  • Published: 01/15/2009
  • Est. Priority Date: 11/14/2003
  • Status: Active Grant
First Claim
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1. A pharmaceutical dosage form of a skeletal muscle relaxant providing a modified release profile comprising a population of extended release (ER) beads,wherein said ER beads comprisean active-containing core particle (IR (immediate release) bead) comprising a skeletal muscle relaxant;

  • andan ER (extended release) coating comprising a water insoluble polymer membrane surrounding said core,wherein said dosage form when dissolution tested using United States Pharmacopoeia Apparatus 2 (paddles @ 50 rpm) in 900 mL of 0.1N HCl at 37°

    C. exhibits a drug release profile substantially corresponding to the following pattern;

    after 2 hours, no more than about 40% of the total active is released;

    after 4 hours, from about 40-65% of the total active is releasedafter 8 hours, from about 60-85% of the total active is released; and

    after 12 hours, from about 75-85% of the total active is released;

    thereby providing therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions in humans.

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