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Details for Patent: 9,393,208

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Details for Patent: 9,393,208

Title:Method for delivering a pharmaceutical composition to patient in need thereof
Abstract: The present disclosure is directed to 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.
Inventor(s): Ault; Brian (Wilmington, DE), Orlemans; Everardus (Chapel Hill, NC), Plachetka; John R. (Chapel Hill, NC), Sostek; Mark (Wilmington, DE)
Assignee: Pozen Inc. (Chapel Hill, NC) Horizon Pharma USA, Inc. (Deerfield, IL)
Filing Date:Dec 28, 2015
Application Number:14/980,639
Claims:1. 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 C.sub.max is 86.2 .mu.g/mL (.+-.20%) and the median T.sub.max is 3.0 hours (.+-.20%); and b) for the PM dose of naproxen, the mean C.sub.max is 76.8 .mu.g/mL (.+-.20%) and the median T.sub.max 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*ng/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*ng/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*ng/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%.

2. The method according to claim 1, wherein the mean % time at which intragastric pH remains at about 4.0 or greater for about a 24 hour period is at least about 71%.

3. The method according to claim 1, wherein said unit dose form is administered for a period of at least about 6 days.

4. The method according to claim 2, wherein said unit dose form is administered for a period of at least about 9 days.

5. The method according to claim 1, wherein said AM and PM unit dose forms are each a multilayer tablet comprising at least one core and at least a first layer and a second layer, wherein: i) said core comprises naproxen, or pharmaceutically acceptable salt thereof; ii) said first layer is a coating that at least begins to release the naproxen, or pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is about 3.5 or greater; and iii) said second layer comprises esomeprazole or a pharmaceutically acceptable salt thereof, wherein said esomeprazole or pharmaceutically acceptable salt thereof is released at a pH of from about 0 or greater.

6. The method according to claim 5, wherein said esomeprazole is released at a pH of from about 0 to about 2.

7. The method according to claim 5, wherein said multi-layer tablet is substantially free of sodium bicarbonate.
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