Sustained release formulations of guaifenesin and additional drug ingredients

CAFC
  • US 6,955,821 B2
  • Filed: 04/15/2002
  • Issued: 10/18/2005
  • Est. Priority Date: 04/28/2000
  • Status: Expired due to Term
First Claim
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1. A modified release drug product comprising a first quantity of guaifenesin in an immediate release formulation wherein the guaifenesin becomes bioavailable in a subject'"'"'s stomach;

  • a second quantity of guaifenesin in a release-delaying matrix; and

    at least one additional drug,wherein the release-delaying matrix comprises a hydrophilic polymer and a water-insoluble polymer in a weight ratio of hydrophilic polymer to water-insoluble polymer from about 1;

    1 to about 9;

    1, wherein the immediate release formulation guaifenesin has a Cmax in a human subject equivalent to the Cmax obtained when a dose of a standard immediate release formulation having one third the amount of guaifenesin is dosed, and immediately after administration the serum concentration of guaifenesin peaks in about an hour, followed by a gradual serum concentration decrease over twenty-four hours but the serum concentration of guaifenesin never decreases below the minimum concentration of said standard immediate release formulation over twelve hours, and wherein the drug product releases a therapeutically effective bioavailable guaifenesin dose for at least twelve hours after a single dose in the human subject according to serum analysis.

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