Claims for Patent: 10,894,046

Summary for Patent: 10,894,046

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):	Tabuteau; Herriot (New York, NY)
Assignee:	ANTECIP BIOVENTURES II LLC (New York, NY)
Application Number:	16/821,330
Patent Claims:	1. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan twice a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises: about 105 mg of bupropion hydrochloride, or a molar equivalent amount of a bupropion in the free base form or another salt form; and about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a dextromethorphan in the free base form or another salt form; wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and wherein the method is more effective in treating major depressive disorder than orally administering 105 mg of bupropion hydrochloride alone twice a day for at least 8 consecutive days. 2. The method of claim 1, wherein the method is more effective in treating major depressive disorder than orally administering 45 mg of dextromethorphan hydrobromide alone twice a day for at least 8 consecutive days. 3. The method of claim 1, wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being. 4. The method of claim 1, wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being for at least 14 consecutive days. 5. The method of claim 1, wherein about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide are orally administered twice a day to the human being for at least 30 consecutive days. 6. The method of claim 1, wherein the combination is orally administered twice a day to the human being for at least 30 days. 7. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan once a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises: about 210 mg of bupropion hydrochloride, or a molar equivalent amount of bupropion in the free base form or another salt form; and about 90 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a dextromethorphan in the free base form or another salt form; wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and wherein the method is more effective in treating major depressive disorder than orally administering 210 mg of bupropion hydrochloride alone once a day for at least 8 consecutive days. 8. The method of claim 7, wherein the method is more effective in treating major depressive disorder than orally administering 90 mg of dextromethorphan hydrobromide alone once a day for at least 8 consecutive days. 9. The method of claim 7, wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being. 10. The method of claim 7, wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being for at least 14 consecutive days. 11. The method of claim 7, wherein about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide are orally administered once a day to the human being for at least 30 consecutive days. 12. The method of claim 7, wherein the combination is orally administered once a day to the human being for at least 30 days. 13. A method of treating major depressive disorder, comprising orally administering a combination of bupropion and dextromethorphan once a day or twice a day to a human being in need thereof for at least 8 consecutive days, wherein the combination comprises: about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide twice a day; about 210 mg of bupropion hydrochloride and about 90 mg of dextromethorphan hydrobromide once a day; or an amount of a bupropion in the free base form or a salt form and an amount of dextromethorphan in the free base form or a salt form once a day or twice a day that provides, to the human being, about the same AUC.sub.0-24 of bupropion and about the same AUC.sub.0-24 of dextromethorphan as administering: about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide twice a day; wherein the combination is orally administered in a single dosage form comprising the bupropion and the dextromethorphan as the only therapeutically active compounds, which provides immediate release of dextromethorphan and sustained release of bupropion; and wherein the method is more effective in treating major depressive disorder than orally administering 105 mg of bupropion hydrochloride alone twice a day for at least 8 consecutive days. 14. The method of claim 13, wherein the method is more effective in treating major depressive disorder than orally administering 45 mg of the dextromethorphan alone twice a day for at least 8 consecutive days. 15. The method of claim 13, wherein the combination is orally administered twice a day to the human being. 16. The method of claim 13, wherein the combination is orally administered once a day to the human being. 17. The method of claim 13, wherein the combination is orally administered for at least 14 consecutive days. 18. The method of claim 13, wherein the combination is orally administered for at least 30 consecutive days. 19. The method of claim 1, wherein the dosage form comprises a pharmaceutically acceptable excipient. 20. The method of claim 7, wherein the dosage form comprises a pharmaceutically acceptable excipient. 21. The method of claim 13, wherein the dosage form comprises a pharmaceutically acceptable excipient. 22. The method of claim 1, wherein the human being has treatment resistant depression. 23. The method of claim 7, wherein the human being has treatment resistant depression. 24. The method of claim 13, wherein the human being has treatment resistant depression. 25. The method of claim 1, wherein the human being is an adult. 26. The method of claim 7, wherein the human being is an adult. 27. The method of claim 13, wherein the human being is an adult.