Claims for Patent: 11,517,543
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Summary for Patent: 11,517,543
| Title: | Bupropion as a modulator of drug activity |
| 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. |
| Inventor(s): | Herriot Tabuteau |
| Assignee: | Antecip Bioventures II LLC |
| Application Number: | US17/525,339 |
| Patent Claims: |
1. A method of treating major depressive disorder, comprising: orally administering, to an adult human suffering from major depressive disorder, a dosage form comprising: about 105 mg of bupropion hydrochloride, formulated for sustained release and about 45 mg of a dextromethorphan, formulated for immediate release, as the only therapeutically active compounds in the dosage form; wherein the dosage form is administered once a day for the first three days, and twice a day thereafter so that the 105 mg of bupropion hydrochloride and the 45 mg of the dextromethorphan are administered once a day or twice a day for at least 14 days. 2. The method of claim 1, wherein the dextromethorphan is dextromethorphan hydrobromide. 3. The method of claim 1, wherein the adult human has a Cmax of bupropion that is about 90 ng/mL after 8 days of dosing. 4. The method of claim 1, wherein the adult human has an AUC0-12 of bupropion that is about 600 ng·hr/mL after 8 days of dosing. 5. The method of claim 1, wherein the adult human has an AUC0-12 of bupropion that is about 700 ng·hr/mL after 8 days of dosing. 6. The method of claim 1, wherein the adult human has an AUC0-12 of bupropion that is about 600 ng·hr/mL to about 700 ng·hr/mL after 8 days of dosing. 7. The method of claim 1, wherein the adult human is suffering from treatment-resistant major depressive disorder. 8. The method of claim 1, wherein the dosage form further comprises microcrystalline cellulose. 9. The method of claim 1, wherein the dosage form further comprises magnesium stearate. 10. The method of claim 1, wherein the adult human has a Tmax of dextromethorphan that is about 4 hours after 8 days of dosing. 11. The method of claim 1, wherein the administration of the dosage form yields an increased elimination half-life of dextromethorphan as compared to a corresponding elimination half-life of dextromethorphan, were the dextromethorphan administered alone. 12. The method of claim 1, wherein administration of the dosage form results in the adult human experiencing an improvement of a depressive symptom. 13. The method of claim 12, wherein the depressive symptom comprises sadness. 14. The method of claim 12, wherein the depressive symptom comprises reduced sleep. 15. The method of claim 12, wherein the depressive symptom comprises reduced appetite. 16. The method of claim 12, wherein the depressive symptom comprises difficulty concentrating. 17. The method of claim 12, wherein the depressive symptom comprises lassitude. 18. The method of claim 12, wherein the depressive symptom comprises pessimism. 19. The method of claim 1, wherein the administration of the dosage form yields higher systemic exposure to dextromethorphan as compared to a corresponding systemic exposure to dextromethorphan, were the 45 mg of the dextromethorphan administered alone. |
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