Method for delivering a pharmaceutical composition to patient in need thereof

CAFC
  • US 9,220,698 B2
  • Filed: 09/03/2009
  • Issued: 12/29/2015
  • Est. Priority Date: 09/09/2008
  • Status: Active Grant
First Claim
Patent Images

1. A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis comprising orally administering to a patient in need thereof an AM unit dose form and, 10 hours (±

  • 20%) later, a PM unit dose form, wherein;

    the AM and PM unit dose forms each comprises;

    naproxen, or a pharmaceutically acceptable salt thereof, in an amount to provide 500 mg of naproxen, andesomeprazole, or a pharmaceutically acceptable salt thereof, in an amount to provide 20 mg of esomeprazole;

    said esomeprazole, or pharmaceutically acceptable salt thereof, is released from said AM and PM unit dose forms at a pH of 0 or greater,the AM and PM unit dose forms target;

    i) a pharmacokinetic (pk) profile for naproxen where;

    a) for the AM dose of naproxen, the mean Cmax is 86.2 μ

    g/mL (±

    20%) and the median Tmax is 3.0 hours (±

    20%); and

    b) for the PM dose of naproxen, the mean Cmax is 76.8 μ

    g/mL (±

    20%) and the median Tmax is 10 hours (±

    20%); and

    ii) a pharmacokinetic (pk) profile for esomeprazole where;

    a) for the AM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the AM dose is administered to 10 hours (±

    20%) after the AM dose is administered (AUC0-10,am) is 1216 hr*μ

    g/mL (±

    20%),b) for the PM dose of esomeprazole, the mean area under the plasma concentration-time curve from when the PM dose is administered to 14 hours (±

    20%) after the PM dose is administered (AUC0-14,pm) is 919 hr*μ

    g/mL (±

    20%), andc) the total mean area under the plasma concentration-time curve for esomeprazole from when the AM dose is administered to 24 hours (±

    20%) after the AM dose is administered (AUC0-24) is 2000 hr*μ

    g/mL (±

    20%); and

    the AM and PM unit dose forms further target a mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period after reaching steady state that is at least about 60%.

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