IP Library › Granted Patent US 12,048,769
Granted Patent B2
US 12,048,769 · App. 16/938,443 · Granted Jul 30, 2024

Methods for administering weight loss medications

Inventors: Anthony A McKinney (San Diego, CA); Gary D. Tollefson (Indianapolis, IN); Eckard Weber (San Diego, CA); Richard Soltero (Holly Springs, NC)
Assignee: Nalpropion Pharmaceuticals LLC
A61K9/209A61J1/035A61J7/04A61K31/135A61K31/137A61K31/138A61K31/35A61K31/42A61K31/423A61K31/485A61K31/551A61K31/5513A61K31/7048A61K45/06B65D75/36A61J7/0454
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Quick Facts
Patent No.
US 12,048,769
App. No.
16/938,443
Granted
Jul 30, 2024
Kind
B2
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.

Claims (28)

1. A method of reducing the risk of side effects associated with the administration of naltrexone and bupropion, the method comprising:

administering a first amount of a pharmaceutical formulation every day for a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion or a pharmaceutically acceptable salt thereof and about 4 mg to about 8 mg of naltrexone or a pharmaceutically acceptable salt thereof;

administering a second amount of a pharmaceutical formulation every day for a second week, wherein the second amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion or salt thereof and about twice as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation;

administering a third amount of a pharmaceutical formulation every day for a third week, wherein the third amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion or salt thereof and about three times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; and

administering a fourth amount of a pharmaceutical formulation every day for a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion or salt thereof and about four times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation.

2. The method of claim 1 , wherein the first amount of a pharmaceutical formulation comprises about 8 mg naltrexone or salt thereof.

3. The method of claim 1 , wherein the first amount of a pharmaceutical formulation comprises about 4 mg naltrexone or salt thereof.

4. The method of claim 1 , wherein the first amount of a pharmaceutical formulation is in 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 amount of a pharmaceutical formulation comprises two of the single oral dosage forms.

7. The method of claim 6 , wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms.

8. The method of claim 7 , wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms.

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

10. The method of claim 9 , wherein the first amount of a pharmaceutical formulation is in a single oral dosage form, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation 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 or salt thereof and a second pharmaceutical layer comprising the sustained release formulation of naltrexone or salt thereof, 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 amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof in a first single oral dosage form and the sustained release naltrexone in a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two of the first single oral dosage forms and two of the second single oral dosage forms, wherein the third amount of a pharmaceutical formulation consists of three of the first single oral dosage forms and three of the second single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation 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 amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof having a first single oral dosage form and the sustained release naltrexone having a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof having a third single oral dosage form, and the sustained release naltrexone having a fourth single oral dosage form, and wherein the third amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof 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 amount of a pharmaceutical formulation 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 , wherein the individual is obese.

15. The method of claim 10 , wherein the individual is obese.

16. The method of claim 11 , wherein the individual is obese.

17. A method of reducing the risk of side effects associated with the administration of naltrexone and bupropion, the method comprising:

providing to the individual a first amount of a pharmaceutical formulation for daily administration during a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion or a pharmaceutically acceptable salt thereof and about 8 mg of naltrexone or a pharmaceutically acceptable salt thereof, wherein the bupropion or salt thereof is in a sustained release formulation and the naltrexone is in a sustained release formulation, and wherein the first amount of a pharmaceutical formulation is in a single oral dosage form;

providing to the individual a second amount of a pharmaceutical formulation for daily administration during a second week, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion or salt thereof and about twice as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation;

providing to the individual a third amount of a pharmaceutical formulation for daily administration during a third week, wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion or salt thereof and about three times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; and

providing to the individual a fourth amount of a pharmaceutical formulation for daily administration during a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion or salt thereof and about four times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation.

18. The method of claim 17 , wherein the individual is obese.

19. The method of claim 17 , wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms.

20. The method of claim 19 , wherein the individual is obese.

Cited By (2)
US 12,303,604 US 12,599,563