Claims for Patent: 9,457,025

Summary for Patent: 9,457,025

Title:	Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan
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:	US14/997,316
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,457,025
Patent Claims:	1. A method of increasing dextromethorphan plasma levels in a human being, comprising co-administering bupropion with about 40 mg to about 500 mg of dextromethorphan once a day or about 10 mg to about 300 mg of dextromethorphan twice a day to the human being for eight consecutive days, wherein the human being is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, and wherein on the eighth day that bupropion and dextromethorphan are co-administered, the co-administration results in an AUC0-12 of dextromethorphan that is at least about 20 times the AUC0-12 that would be achieved by administering the same amount of dextromethorphan without bupropion for eight consecutive days. 2. The method of claim 1, wherein the AUC0-12 of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 500 ng·hr/m L. 3. The method of claim 1, wherein the AUC0-12 of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is about 800 ng·hr/mL to about 900 ng·hr/mL. 4. The method of claim 1, wherein the AUC0-24 of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 600 ng·hr/mL. 5. The method of claim 1, wherein the AUC0-inf of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 1000 ng·hr/mL. 6. The method of claim 1, wherein the AUC0-inf of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered is at least about 2000 ng·hr/mL. 7. The method of claim 1, wherein the Cmax of dextromethorphan on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 10 ng/mL. 8. The method of claim 1, wherein the Cmax of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 40 ng/mL. 9. The method of claim 1, wherein the Cmax of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 60 ng/mL. 10. The method of claim 1, wherein an excess of one stereoisomer of bupropion is administered. 11. The method of claim 1, wherein an excess of the S-enantiomer of bupropion is administered. 12. The method of claim 1, wherein an excess of the R-enantiomer of bupropion is administered. 13. The method of claim 1, wherein about 160 mg to about 260 mg of bupropion per day is administered to the human being. 14. The method of claim 1, wherein about 185 mg to about 235 mg of bupropion per day is administered to the human being. 15. The method of claim 1, wherein about 40 mg to about 140 mg of dextromethorphan per day is administered to the human being. 16. The method of claim 1, wherein about 65 mg to about 115 mg of dextromethorphan per day is administered to the human being. 17. The method of claim 1, wherein about 200 mg to about 220 mg of bupropion and about 80 mg to about 100 mg of dextromethorphan is administered to the human being per day. 18. The method of claim 1, wherein the bupropion and the dextromethorphan are administered in a single dosage form. 19. The method of claim 1, wherein the bupropion is in a sustained-release formulation. 20. The method of claim 17, wherein the bupropion is in a sustained release formulation and the dextromethorphan is in an immediate release formulation. 21. The method of claim 18, wherein the bupropion is in a sustained-release formulation and the dextromethorphan is in an immediate-release formulation. 22. A method of increasing exposure to dextromethorphan in a human being, comprising co-administering bupropion with about 40 mg to about 500 mg of dextromethorphan once a day in a single dosage form or about 10 mg to about 300 mg of dextromethorphan twice a day in a single dosage form to the human being for eight consecutive days, wherein the human being is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, and wherein on the eighth day that bupropion and dextromethorphan are co-administered, the co-administration results in an AUC0-12 of dextromethorphan that is at least about 15 times the AUC0-12 that would be achieved by administering the same amount of dextromethorphan without bupropion for eight consecutive days. 23. The method of claim 22, wherein the AUC0-12 of dextromethorphan, on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 500 ng·hr/m L. 24. The method of claim 22, wherein the Cmax, of dextromethorphan on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 10 ng/mL. 25. The method of claim 22, wherein the Cavg of dextromethorphan on the eighth day that bupropion and dextromethorphan are co-administered, is at least about 100 ng/mL. 26. The method of claim 22, wherein an excess of one stereoisomer of bupropion is administered. 27. The method of claim 22, wherein an excess of the S-enantiomer of bupropion is administered. 28. The method of claim 22, wherein an excess of the R-enantiomer of bupropion is administered. 29. The method of claim 22, wherein about 200 mg to about 220 mg of bupropion and about 80 mg to about 100 mg of dextromethorphan is administered to the human being per day. 30. The method of claim 22, wherein the bupropion is in a sustained-release formulation and the dextromethorphan is in an immediate-release formulation.