Granted Patent B2

US 12,740,949 · App. 19/571,930 · Granted Sep 22, 2026

Inventor: Herriot Tabuteau (New York, NY)

Assignee: ANTECIP BIOVENTURES II LLC

A61K31/137A61K9/2009A61K9/2013A61K9/2027A61K9/2054A61K9/2086A61K31/485

Abstract

Claims (23)

1 . A method of treating agitation associated with Alzheimer's disease in a human patient having agitation associated with Alzheimer's disease comprising: 1) orally administering a first dosage form once daily for one week to the human patient, then administering the first dosage form twice daily to the human patient for one week; and 2) then orally administering a second dosage form twice daily to the human patient for at least one week; wherein the human patient has mild or moderate hepatic impairment;

wherein the first dosage form comprises about 30 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, about 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and a polymer;

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

wherein the first and second dosage forms are bilayertablets, wherein the bupropion and the dextromethorphan in each of the tablets are in separate layers.

2 . The method of claim 1 , wherein the first or second dosage form further comprises colloidal silicon dioxide.

3 . The method of claim 1 , wherein the first or second dosage form further comprises crospovidone.

4 . The method of claim 1 , wherein the first or second dosage form further comprises glyceryl monocaprylocaprate.

5 . The method of claim 1 , wherein the first or second dosage form further comprises L-cysteine hydrochloride monohydrate.

6 . The method of claim 1 , wherein the first or second dosage form further comprises magnesium stearate.

7 . The method of claim 1 , wherein the first or second dosage form further comprises microcrystalline cellulose.

8 . The method of claim 1 , wherein the first or second dosage form further comprises polyvinyl alcohol.

9 . The method of claim 1 , wherein the first or second dosage form further comprises sodium lauryl sulfate.

10 . The method of claim 1 , wherein the first or second dosage form further comprises stearic acid.

11 . The method of claim 1 , wherein the first or second dosage form further comprises titanium dioxide.

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

13 . The method of claim 1 , wherein the first or second dosage form further comprises: carbomer homopolymer, 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.

14 . The method of claim 1 , wherein the first or second dosage form comprises about 105 mg of bupropion hydrochloride.

15 . The method of claim 1 , wherein the first dosage form comprises about 30 mg of dextromethorphan hydrobromide.

16 . The method of claim 14 , wherein the first dosage form comprises about 30 mg of dextromethorphan hydrobromide.

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

18 . The method of claim 14 , wherein the second dosage form comprises about 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.

Assignments (1)

Continuity (8)

References Cited (400)