Modified release dosage forms of skeletal muscle relaxants

  • US 9,399,025 B2
  • Filed: 12/08/2014
  • Issued: 07/26/2016
  • Est. Priority Date: 11/14/2003
  • Status: Expired due to Fees
First Claim
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1. A dosage form comprising a plurality of active-containing particles comprising cyclobenzaprine hydrochloride and a dissolution rate controlling polymer granulated together,wherein the dissolution rate controlling polymer is selected from the group consisting of ethers of cellulose and esters of cellulose;

  • wherein the 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 released; and

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

    wherein the dosage form provides a therapeutically effective plasma concentration over a period of 24 hours to treat muscle spasm associated with painful musculoskeletal conditions.

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