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:

• administering to said patient a pharmaceutical composition in unit dose form comprising naproxen, or pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically acceptable salt thereof, wherein said esomeprazole, or pharmaceutically acceptable salt thereof, is released from said unit dose form at a pH of from about 0 or greater, wherein one unit dose form is administered as an AM dose and a second dose administered about 10 hours later as a PM dose to target:
• i) a pharmacokinetic (pk) profile for naproxen where:
• a) the AM dose has a mean Cmax of about 81 μg/mL and a median time to maximum concentration (Tmax) of from about 2.5 to about 4 hours, and
• b) the PM dose has a mean Cmax of about 76.2 μg/mL and a median Tmax of from about 10 to about 14 hours;
• and
• ii) a pharmacokinetic (pk) profile for esomeprazole where:
• a) the AM dose has a mean area under the plasma concentration-time curve from time zero when the AM dose is administered to about 10 hours after the AM dose is administered (AUC0-10,am) of about 850 hr/*μg/mL, and
• b) the PM dose has a mean area under the plasma concentration-time curve from time zero when the PM dose is administered to about 14 hours after the PM dose is administered (AUC0-14,pm) of about 650 hr*μg/mL.