Bupropion as a modulator of drug activity
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.
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 for at least 8 consecutive 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 and the dosage form is formulated for sustained release of bupropion and immediate release of dextromethorphan, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is headache.
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.