Granted Patent B2

US 12,239,642 · App. 18/590,452 · Granted Mar 4, 2025

Inventor: Herriot Tabuteau (New York, NY)

Assignee: ANTECIP BIOVENTURES II LLC

A61K31/485A61K9/2027A61K9/2086A61K31/138

Abstract

Claims (24)

1. A method of treating agitation associated with Alzheimer's disease, comprising: 1) selecting a human patient having agitation associated with Alzheimer's disease who is consuming alcohol; 2) administering a dosage form twice a day to the human patient to treat the agitation associated with Alzheimer's disease; and 3) advising the human patient to minimize, but not abruptly discontinue, alcohol consumption;

wherein the dosage form comprises 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and a polymer; and

wherein the human patient minimizes, but does not abruptly discontinue, alcohol consumption.

2. The method of claim 1 , wherein the human patient is an adult male, and the human patient consumes two servings or less of alcohol per day after the human patient is advised to minimize alcohol consumption.

3. The method of claim 1 , wherein the human patient is an adult female, and the human patient consumes one serving or less of alcohol per day after the human patient is advised to minimize alcohol consumption.

4. The method of claim 1 , wherein the dosage form further comprises colloidal silicon dioxide.

5. The method of claim 1 , wherein the dosage form further comprises crospovidone.

6. The method of claim 1 , wherein the dosage form further comprises: glyceryl monocaprylocaprate.

7. The method of claim 1 , wherein the dosage form further comprises L-cysteine hydrochloride monohydrate.

8. The method of claim 1 , wherein the dosage form further comprises magnesium stearate.

9. The method of claim 1 , wherein the dosage form further comprises microcrystalline cellulose.

10. The method of claim 1 , wherein the dosage form further comprises polyvinyl alcohol.

11. The method of claim 1 , wherein the dosage form further comprises sodium lauryl sulfate.

12. The method of claim 1 , wherein the dosage form further comprises stearic acid.

13. The method of claim 1 , wherein the dosage form further comprises titanium dioxide.

14. The method of claim 1 , wherein the polymer is a carbomer homopolymer.

15. The method of claim 1 , wherein the dosage form further comprises: colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, L-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, red iron oxide, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, or yellow iron oxide, or a combination thereof.

16. The method of claim 1 , wherein the dosage form comprises 105 mg of bupropion hydrochloride.

17. The method of claim 1 , wherein the dosage form comprises 45 mg of dextromethorphan hydrobromide.

18. The method of claim 16 , wherein the dosage form comprises 45 mg of dextromethorphan hydrobromide.

19. The method of claim 1 , wherein the dextromethorphan is formulated for immediate release.

20. The method of claim 19 , wherein the bupropion is formulated for extended release.

21. The method of claim 1 , wherein the dosage form is administered orally.

22. The method of claim 1 , wherein the dosage form has reduced alcohol dosing effects as compared with administering twice a day the same amount of the bupropion alone.

Assignments (1)

Continuity (6)

References Cited (400)

Cited By (14)

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