Compositions and methods for delivery of omeprazole plus acetylsalicylic acid

  • US 9,539,214 B2
  • Filed: 12/27/2012
  • Issued: 01/10/2017
  • Est. Priority Date: 12/28/2011
  • Status: Active Grant
First Claim
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1. A method for delivering a pharmaceutical composition to a patient in need thereof, comprising administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and omeprazole, or pharmaceutically acceptable salt thereof, wherein said omeprazole, or pharmaceutically acceptable salt thereof, wherein said omeprazole, or pharmaceutically acceptable salt thereof is an immediate release omeprazole, or pharmaceutically acceptable salt thereof and is released from said unit dose form at a pH of from about 0 or greater to 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 of at least about 50% and wherein one unit dose form is administered to target:

  • i) a pharmacokinetic (pk) profile for acetylsalicylic acid where;

    a) the dose has a acetylsalicylic acid mean Cmax of about 2.0 to about 3.0 μ

    g/mL and a median time to maximum concentration (Tmax) of from about 3.0 to about 3.5 hours, and/orb) the dose has a salicylic acid mean Cmax of about 15 to about 16.5 μ

    g/mL and a median time to maximum concentration (Tmax) of from about 3.0 to about 3.5 hours,ii) a pharmacokinetic (pk) profile for omeprazole where the dose has a mean area under the plasma concentration-time curve from time zero when the dose is administered to about 12 hours after the dose is administered (AUC0-12) of about 0.8 to about 2.5 hr*μ

    g/mL.

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