Method for delivering a pharmaceutical composition to patient in need thereof

A method for delivering a pharmaceutical composition to a patient in need thereof, comprising:

• orally administering to the patient 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:
• i) naproxen, or a pharmaceutically acceptable salt thereof, in an amount to provide 500 mg of naproxen, and
• ii) esomeprazole, 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 μg/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 μg/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*μg/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*μg/mL (±20%), and
• c) 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*μg/mL (±20%);
• and
• the AM and PM unit dose forms farther 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%.