IP Library Granted Patent US 11,517,544
Granted Patent B2
US 11,517,544 · App. 17/707,221 · Granted Dec 6, 2022

Bupropion as a modulator of drug activity

Inventor: Herriot Tabuteau (New York, NY)
Assignee: ANTECIP BIOVENTURES II LLC
A61K31/138A61K9/0053A61K31/485A61P25/24A61P25/00
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Quick Facts
Patent No.
US 11,517,544
App. No.
17/707,221
Granted
Dec 6, 2022
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 (19)

1. A method of treating major depressive disorder, comprising administering a dosage form by mouth once daily or twice daily to a human patient in need thereof, wherein the dosage form comprises about 105 mg of bupropion hydrochloride and about 45 mg of a dextromethorphan salt as the only therapeutically active compounds in the dosage form, wherein bupropion hydrochloride is in a sustained release formulation and the dextromethorphan salt is in an immediate release formulation, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is seizure.

2. The method of claim 1 , wherein the dosage form is a tablet.

3. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

4. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

5. The method of claim 1 , wherein the dextromethorphan salt is dextromethorphan hydrobromide.

6. The method of claim 5 , wherein the dosage form is a tablet.

7. The method of claim 5 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

8. The method of claim 5 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

9. The method of claim 5 , wherein the human patient is an extensive CYP2D6 metabolizer.

10. The method of claim 9 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter.

11. The method of claim 1 , wherein the human patient is an extensive CYP2D6 metabolizer.

12. The method of claim 11 , wherein the dosage form is a tablet.

13. The method of claim 11 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

14. The method of claim 11 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

15. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter.

16. The method of claim 15 , wherein the human patient is an extensive CYP2D6 metabolizer.

17. The method of claim 15 , wherein the dosage form is a tablet.

18. The method of claim 16 , wherein the dosage form is administered for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

19. The method of claim 16 , wherein the dosage form is administered for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2022
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 059739/0835 →
Cited By (3)
US 12,653,795 US 12,661,408 US 12,678,506