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, comprising orally administering a dosage form to a human being twice daily for at least eight consecutive days, wherein the dosage form comprises a bupropion and a dextromethorphan, wherein the human being is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, and wherein on the eighth day that the dosage form is administered twice daily, the method results in a C max of dextromethorphan, that is: 1) at least about 40 ng/mL, and 2) at least about 15 times the C max of dextromethorphan that would be achieved by administering the same amount of the dextromethorphan without the bupropion twice daily for eight consecutive days.
2 . The method of claim 1 , wherein the dosage form is a solid.
3 . The method of claim 2 , wherein the solid oral dosage form further comprises a binder.
4 . The method of claim 2 , wherein the solid oral dosage form further comprises a disintegrating agent.
5 . The method of claim 2 , wherein the solid oral dosage form further comprises a lubricant.
6 . The method of claim 1 , wherein the dosage form is effective for immediate release of the dextromethorphan.
7 . The method of claim 1 , wherein the dosage form is effective for sustained release of the bupropion.
8 . The method of claim 1 , wherein the C max of dextromethorphan on the eighth day that the dosage form is administered twice daily is about 45 ng/mL to about 70 ng/mL.
9 . The method of claim 1 , wherein the C max of dextromethorphan on the eighth day that the dosage form is administered twice daily is about 50 ng/mL to about 60 ng/mL.
10 . The method of claim 1 , wherein the AUC 0-12 of dextromethorphan on the eighth day that the dosage form is administered twice daily is about 400 ng·hr/mL to about 700 ng·hr/mL.
11 . The method of claim 1 , wherein the dosage form contains about 45 mg of the dextromethorphan.
12 . The method of claim 11 , wherein the daily dose of the bupropion is about 200 mg to about 250 mg.
13 . A method for treating a human being with dextromethorphan, comprising administering a dosage form comprising a dextromethorphan and a bupropion twice daily for at least eight consecutive days, wherein the human being is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, wherein the method results in an AUC 0-12 of dextromethorphan, on the eighth day that the dosage form is administered twice daily, that is at least about 400 ng·hr/mL, and wherein the AUC 0-12 of dextromethorphan, on the eighth day that the dosage form is administered twice daily is at least about 20 times the AUC 0-12 of dextromethorphan that would result from administering the same amount of dextromethorphan without bupropion.
14 . The method of claim 13 , wherein the AUC 0-12 of dextromethorphan on the eighth day that the dosage form is administered twice daily is at least about 600 ng·hr/mL.
15 . The method of claim 13 , wherein the C max of dextromethorphan on the eighth day that the dosage form is administered twice daily is about 45 ng/mL to about 70 ng/mL.
16 . The method of claim 13 , wherein the dosage form is a solid.
17 . The method of claim 16 , wherein the dosage form further comprises a binder.
18 . The method of claim 16 , wherein the dosage form further comprises a disintegrating agent.
19 . The method of claim 16 , wherein the dosage form further comprises a lubricant.
20 . The method of claim 13 , wherein the dosage form is effective for immediate release of dextromethorphan.
21 . The method of claim 13 , wherein the dosage form is effective for sustained release of bupropion.
22 . The method of claim 13 , wherein the dosage form contains about 45 mg of the dextromethorphan.
23 . The method of claim 13 , wherein the daily dose of the bupropion is about 200 mg to about 250 mg.