Claims for Patent: 11,147,808

Summary for Patent: 11,147,808

Title:	Method of decreasing the fluctuation index 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):	Tabuteau; Herriot (New York, NY)
Assignee:	ANTECIP BIOVENTURES II LLC (New York, NY)
Application Number:	17/194,739
Patent Claims:	1. A method of decreasing the fluctuation index of dextromethorphan, comprising co-administering a bupropion and a dextromethorphan to a human being who is a non-poor metabolizer of dextromethorphan, wherein the human being receives about 70 mg to about 150 mg of the bupropion and about 30 mg to about 60 mg of the dextromethorphan once a day for three consecutive days followed by twice a day for at least 5 consecutive days, wherein the fluctuation index of dextromethorphan on the eighth day is about 20% to about 30%, and the fluctuation index of dextromethorphan on the eighth day is reduced by at least about 70% as compared to the fluctuation index of dextromethorphan that would result from administering 60 mg of the dextromethorphan alone once a day for three consecutive days followed by twice a day for at least 5 consecutive days. 2. The method of claim 1, wherein the bupropion and the dextromethorphan are co-administered for at least 14 consecutive days. 3. The method of claim 1, wherein the bupropion and the dextromethorphan are co-administered for at least 30 consecutive days. 4. The method of claim 1, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of depression. 5. The method of claim 1, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of nicotine addiction. 6. The method of claim 1, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of agitation associated with Alzheimer's disease. 7. The method of claim 1, wherein about 105 mg of bupropion hydrochloride, or a molar equivalent amount of the free base or another salt form of bupropion, is co-administered with about 44 mg to about 46 mg of dextromethorphan hydrobromide, or a molar equivalent amount of the free base or another salt form of dextromethorphan, once a day for three consecutive days followed by twice a day for at least 5 consecutive days. 8. The method of claim 7, wherein the bupropion and the dextromethorphan are administered as the only active agents in a single dosage form. 9. The method of claim 8, wherein the dextromethorphan is formulated for immediate release. 10. The method of claim 9, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of depression. 11. The method of claim 9, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of nicotine addiction. 12. The method of claim 9, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of agitation associated with Alzheimer's disease. 13. The method of claim 1, wherein the fluctuation index of dextromethorphan on the eighth day is about 25% to about 28%. 14. The method of claim 13, wherein the bupropion and the dextromethorphan are co-administered for at least 30 consecutive days. 15. The method of claim 13, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of depression. 16. The method of claim 13, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of nicotine addiction. 17. The method of claim 13, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of agitation associated with Alzheimer's disease. 18. The method of claim 13, wherein about 105 mg of bupropion hydrochloride, or a molar equivalent amount of the free base or another salt form of bupropion, is co-administered with about 44 mg to about 46 mg of dextromethorphan hydrobromide, or a molar equivalent amount of the free base or another salt form of dextromethorphan, once a day for three consecutive days followed by twice a day for at least 5 consecutive days. 19. The method of claim 18, wherein the bupropion and the dextromethorphan are administered as the only active agents in a single dosage form. 20. The method of claim 19, wherein the dextromethorphan is formulated for immediate release. 21. The method of claim 20, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of depression. 22. The method of claim 20, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of nicotine addiction. 23. The method of claim 20, wherein the bupropion and the dextromethorphan are co-administered to the human being for the treatment of agitation associated with Alzheimer's disease. 24. The method of claim 1, wherein the C.sub.max of dextromethorphan on the eighth day is about 158 ng/mL. 25. The method of claim 24, wherein the C.sub.ave of dextromethorphan on the eighth day is about 140 ng/mL. 26. The method of claim 25, wherein the C.sub.min of dextromethorphan on the eighth day is at least 115 ng/mL. 27. The method of claim 26, wherein the fluctuation index of dextromethorphan on the eighth day is about 30%. 28. The method of claim 25, wherein the C.sub.min of dextromethorphan on the eighth day is about 119 ng/mL. 29. The method of claim 28, wherein the fluctuation index of dextromethorphan on the eighth day is about 28%.