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Claims for Patent: 8,722,085

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Claims for Patent: 8,722,085

Title:Methods for administering weight loss medications
Abstract: Methods and systems for administration of pharmaceuticals using a unit dosage package that includes a first unit dosage that has a first drug and a second drug, a second unit dosage that has the first drug and the second drug, where the second unit dosage includes a different amount of the second drug than the first unit dosage and a unit dosage package is configured to hold the first unit dosage and the second unit dosage. In preferred embodiments the methods and systems are used for administration of weight loss medications.
Inventor(s): McKinney; Anthony (San Diego, CA), Tollefson; Gary (Indianapolis, IN), Weber; Eckard (San Diego, CA), Soltero; Rick (Holly Springs, NC)
Assignee: Orexigen Therapeutics, Inc. (La Jolla, CA)
Application Number:12/838,364
Patent Claims: 1. A method of administering a pharmaceutical formulation to an individual, comprising: administering a first unit dosage every day for a first week, wherein the first unit dosage comprises about 90 mg of bupropion and an amount of naltrexone selected from the group consisting of about 4 mg and about 8 mg; administering a second unit dosage every day for a second week, wherein the second unit dosage comprises bupropion and naltrexone, and wherein the second unit dosage comprises about twice as much bupropion and about twice as much naltrexone as the first unit dosage; administering a third unit dosage every day for a third week, wherein the third unit dosage comprises bupropion and naltrexone, and wherein the third unit dosage comprises about three times as much bupropion and about three times as much naltrexone as the first unit dosage; and administering a fourth unit dosage every day for a fourth week, wherein the fourth unit dosage comprises bupropion and naltrexone, and wherein the fourth unit dosage comprises about four times as much bupropion and about four times as much naltrexone as the first unit dosage.

2. The method of claim 1, wherein the first unit dosage comprises about 8 mg naltrexone.

3. The method of claim 1, wherein the first unit dosage comprises about 4 mg naltrexone.

4. The method of claim 1, wherein the first unit dosage is a single oral dosage form.

5. The method of claim 4, wherein the single oral dosage form is selected from the group consisting of a tablet, a pill and a capsule.

6. The method of claim 4, wherein the second unit dosage comprises two of the single oral dosage forms.

7. The method of claim 6, wherein the third unit dosage comprises three of the single oral dosage forms.

8. The method of claim 7, wherein the fourth unit dosage comprises four of the single oral dosage forms.

9. The method of claim 1, wherein the bupropion is in a sustained release formulation and the naltrexone is in a sustained release formulation.

10. The method of claim 9, wherein the first unit dosage is a single oral dosage form, wherein the second unit dosage comprises two of the single oral dosage forms, wherein the third unit dosage comprises three of the single oral dosage forms, and wherein the fourth unit dosage comprises four of the single oral dosage forms.

11. The method of claim 10, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo.

12. The method of claim 9, wherein the first unit dosage consists of two single oral dosages forms, the sustained release bupropion in a first single oral dosage form and the sustained release naltrexone in a second single oral dosage form, wherein the second unit dosage consists of two of the first single oral dosage forms and two of the second single oral dosage forms, wherein the third unit dosage consists of three of the first single oral dosage forms and three of the second single oral dosage forms, and wherein the fourth unit dosage consists of four of the first single oral dosage forms and four of the second single oral dosage forms.

13. The method of claim 9, wherein the first unit dosage consists of two single oral dosages forms, the sustained release bupropion having a first single oral dosage form and the sustained release naltrexone having a second single oral dosage form, wherein the second unit dosage consists of two single oral dosages forms, the sustained release bupropion having a third single oral dosage form, and the sustained release naltrexone having a fourth single oral dosage foam, and wherein the third unit dosage consists of two single oral dosages forms, the sustained release bupropion having the first single oral dosage form and the third single oral dosage form, and the sustained release naltrexone having the second single oral dosage form and the fourth single oral dosage form, wherein the fourth unit dosage consists of two of the third single oral dosage forms and two of the fourth single oral dosage forms.

14. The method of claim 1, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

15. The method of claim 10, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

16. The method of claim 11, further comprising identifying said individual as obese, and said administering of said pharmaceutical formulation is for treatment of obesity.

17. A method of administering a pharmaceutical formulation to an obese individual, comprising: identifying an individual as obese; providing to the individual a first unit dosage for daily administration during a first week, wherein the first unit dosage comprises about 90 mg of bupropion and an amount of naltrexone selected from the group consisting of about 4 mg and about 8 mg, wherein the bupropion is in a sustained release formulation and the naltrexone is in a sustained release formulation, and wherein the first unit dosage is a single oral dosage form; providing to the individual a second unit dosage for daily administration during a second week, and wherein the second unit dosage comprises about twice as much bupropion and about twice as much naltrexone as the first unit dosage; providing to the individual a third unit dosage for daily administration during a third week, wherein the third unit dosage comprises about three times as much bupropion and about three times as much naltrexone as the first unit dosage; and providing to the individual a fourth unit dosage for daily administration during a fourth week, wherein the fourth unit dosage comprises about four times as much bupropion and about four times as much naltrexone as the first unit dosage, and wherein the providing of the first unit dosage, the second unit dosage, the third unit dosage and the fourth unit dosage are for treatment of obesity.
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