Claims for Patent: 12,357,697

Summary for Patent: 12,357,697

Title:	Pharmaceutical compositions comprising bupropion and cysteine
Abstract:	This disclosure relates to pharmaceutical compositions comprising bupropion and cysteine, and pharmaceutical dosage forms comprising bupropion and cysteine. The disclosure also relates to molecular complexes of bupropion and cysteine. These compositions and dosage forms may have improved stability of bupropion.
Inventor(s):	Herriot Tabuteau
Assignee:	Axsome Therapeutics Inc
Application Number:	US18/921,291
Patent Claims:	1. A method of treating depression in a human being in need thereof with a dosage form comprising dextromethorphan, bupropion and cysteine, comprising orally administering the dosage form comprising the dextromethorphan, the bupropion, and the cysteine, wherein the dosage form is a solid and comprises the dextromethorphan in the free base form or a salt form, about 100 mg to about 120 mg of the bupropion in the free base form or a salt form, and about 50 mg to about 100 mg of the cysteine in the neutral form or a salt form, wherein the dosage form has a molar ratio of the bupropion to the cysteine that is about 0.5:1 to about 1.1:1, wherein bupropion and dextromethorphan, are the only therapeutic active agents in the dosage form, wherein the dosage form is a bilayer dosage form, and wherein the bupropion and the cysteine are in a first layer and the dextromethorphan is in a second layer. 2. The method of claim 1, wherein the dosage form has a molar ratio of the bupropion to the cysteine that is about 0.7:1 to about 1.1:1. 3. The method of claim 1, wherein the molar ratio of the bupropion to the cysteine is about 1:1. 4. The method of claim 1, wherein the dosage form further comprises a sustained release polymer. 5. The method of claim 4, wherein the sustained release polymer is an acrylate polymer or copolymer, a methylcellulose, or a combination thereof. 6. The method of claim 1, wherein the dosage form is in the form of a capsule, a pill, or a tablet. 7. The method of claim 1, wherein the dosage form further comprises a filler. 8. The method of claim 7, wherein the filler is microcrystalline cellulose. 9. The method of claim 1, wherein the dosage form further comprises a lubricant. 10. The method of claim 9, wherein the lubricant is magnesium stearate. 11. The method of claim 1, wherein the cysteine is L-cysteine hydrochloride monohydrate. 12. The method of claim 1, wherein the dosage form comprises a molecular complex of bupropion and cysteine. 13. The method of claim 1, wherein the bupropion in the dosage form is more stable than bupropion alone. 14. The method of claim 12, wherein the bupropion in the dosage form is more stable than bupropion alone. 15. The method of claim 1, wherein the bupropion is bupropion hydrochloride. 16. The method of claim 15, wherein the cysteine is L-cysteine hydrochloride monohydrate. 17. The method of claim 16, wherein the molar ratio of the bupropion to the cysteine is about 1:1.