IP Library Granted Patent US 10,894,046
Granted Patent B2
US 10,894,046 · App. 16/821,330 · Granted Jan 19, 2021

Bupropion as a modulator of drug activity

Inventor: Herriot Tabuteau (New York, NY)
Assignee: ANTECIP BIOVENTURES II LLC
A61K31/485A61K9/0053A61K31/135A61K31/137A61K31/15A61K31/343A61K31/381
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Quick Facts
Patent No.
US 10,894,046
App. No.
16/821,330
Granted
Jan 19, 2021
Kind
B2
Abstract

Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Claims (40)

1. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan twice a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises:

about 105 mg of bupropion hydrochloride, or a molar equivalent amount of a bupropion in the free base form or another salt form; and

about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a dextromethorphan in the free base form or another salt form;

wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and

wherein the method is more effective in treating major depressive disorder than orally administering 105 mg of bupropion hydrochloride alone twice a day for at least 8 consecutive days.

2. The method of claim 1 , wherein the method is more effective in treating major depressive disorder than orally administering 45 mg of dextromethorphan hydrobromide alone twice a day for at least 8 consecutive days.

3. The method of claim 1 , wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being.

4. The method of claim 1 , wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being for at least 14 consecutive days.

5. The method of claim 1 , wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being for at least 30 consecutive days.

6. The method of claim 1 , wherein the combination is orally administered twice a day to the human being for at least 30 days.

7. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan once a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises:

about 210 mg of bupropion hydrochloride, or a molar equivalent amount of bupropion in the free base form or another salt form; and

about 90 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a dextromethorphan in the free base form or another salt form;

wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and

wherein the method is more effective in treating major depressive disorder than orally administering 210 mg of bupropion hydrochloride alone once a day for at least 8 consecutive days.

8. The method of claim 7 , wherein the method is more effective in treating major depressive disorder than orally administering 90 mg of dextromethorphan hydrobromide alone once a day for at least 8 consecutive days.

9. The method of claim 7 , wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being.

10. The method of claim 7 , wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being for at least 14 consecutive days.

11. The method of claim 7 , wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being for at least 30 consecutive days.

12. The method of claim 7 , wherein the combination is orally administered once a day to the human being for at least 30 days.

13. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan once a day or twice a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises:

about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide twice a day;

about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide once a day; or

an amount of a bupropion in the free base form or a salt form and an amount of dextromethorphan in the free base form or a salt form once a day or twice a day that provides, to the human being, about the same AUC 0-24 of bupropion and about the same AUC 0-24 of dextromethorphan as administering: about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide twice a day;

wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and

wherein the method is more effective in treating major depressive disorder than orally administering 105 mg of bupropion hydrochloride alone twice a day for at least 8 consecutive days.

14. The method of claim 13 , wherein the method is more effective in treating major depressive disorder than orally administering 45 mg of the dextromethorphan alone twice a day for at least 8 consecutive days.

15. The method of claim 13 , wherein the combination is orally administered twice a day to the human being.

16. The method of claim 13 , wherein the combination is orally administered once a day to the human being.

17. The method of claim 13 , wherein the combination is orally administered for at least 14 consecutive days.

18. The method of claim 13 , wherein the combination is orally administered for at least 30 consecutive days.

19. The method of claim 1 , wherein the dosage form comprises a pharmaceutically acceptable excipient.

20. The method of claim 7 , wherein the dosage form comprises a pharmaceutically acceptable excipient.

21. The method of claim 13 , wherein the dosage form comprises a pharmaceutically acceptable excipient.

22. The method of claim 1 , wherein the human being has treatment resistant depression.

23. The method of claim 7 , wherein the human being has treatment resistant depression.

24. The method of claim 13 , wherein the human being has treatment resistant depression.

25. The method of claim 1 , wherein the human being is an adult.

26. The method of claim 7 , wherein the human being is an adult.

27. The method of claim 13 , wherein the human being is an adult.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2020
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 052456/0646 →