Bupropion as a modulator of drug activity
Disclosed herein are methods of treating neurological or psychiatric diseases or disorders using a combination of bupropion and dextromethorphan. Related compositions and dosage forms are also described.
1. A method of treating major depressive disorder, comprising administering a dosage form by mouth once daily for three days followed by twice daily by mouth to a human patient in need thereof for a total of at least 8 days, 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 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, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is dizziness.
2. The method of claim 1 , wherein the dosage form is a tablet.
3. The method of claim 1 , wherein bupropion hydrochloride is in a sustained release formulation.
4. The method of claim 3 , wherein the dextromethorphan salt is in an immediate release formulation.
5. The method of claim 1 , 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.
6. The method of claim 1 , wherein the dextromethorphan salt is dextromethorphan hydrobromide.
7. The method of claim 6 , wherein the dosage form is a tablet.
8. The method of claim 6 , wherein bupropion hydrochloride is in a sustained release formulation.
9. The method of claim 8 , wherein dextromethorphan hydrobromide is in an immediate release formulation.
10. The method of claim 6 , 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.
11. The method of claim 6 , wherein the human patient is an extensive CYP2D6 metabolizer.
12. 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.
13. The method of claim 1 , wherein the human patient is an extensive CYP2D6 metabolizer.
14. The method of claim 13 , wherein the dosage form is a tablet.
15. The method of claim 13 , wherein bupropion hydrochloride is in a sustained release formulation.
16. The method of claim 15 , wherein the dextromethorphan salt is in an immediate release formulation.
17. The method of claim 13 , 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.
18. A method of treating major depressive disorder, comprising administering a dosage form by mouth once daily for three days followed by twice daily by mouth to a human patient in need thereof for a total of at least 8 days, wherein the dosage form consists essentially of about 105 mg of bupropion hydrochloride and about 45 mg of a dextromethorphan salt, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, 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, and wherein the adverse event is dizziness.
19. A method of treating major depressive disorder, comprising orally administering a dosage form once daily by mouth for three days followed by twice daily by mouth to a human patient in need thereof, for a total of at least 8 days wherein the therapeutically active compounds in the dosage form consist of (i) about 105 mg of bupropion hydrochloride and (ii) about 45 mg of a dextromethorphan salt, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, 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, and wherein the adverse event is dizziness.