Pharmaceutical compositions comprising bupropion and cysteine
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.
1 . A solid pharmaceutical dosage form comprising about 105 mg of bupropion hydrochloride, and about 50 mg to about 95 mg of cysteine in the neutral form or a salt form, and wherein the solid pharmaceutical dosage form has a molar ratio of the bupropion to the cysteine that is about 0.7:1 to about 1.1:1.
2 . The solid pharmaceutical dosage form according to claim 1 , wherein the cysteine is L-Cysteine hydrochloride.
3 . The solid pharmaceutical dosage form according to claim 2 , wherein the cysteine is L-Cysteine hydrochloride monohydrate.
4 . The solid pharmaceutical dosage form according to claim 1 , wherein the dosage form further comprises about 30 mg to about 60 mg of dextromethorphan, or a molar equivalent of a pharmaceutically acceptable salt thereof.
5 . The solid pharmaceutical dosage form according to claim 4 , wherein the dextromethorphan is dextromethorphan hydrobromide.
6 . The solid pharmaceutical dosage form according to claim 5 , wherein the solid pharmaceutical dosage form further comprises a filler.
7 . The solid pharmaceutical dosage form according to claim 6 , wherein the filler is microcrystalline cellulose.
8 . The solid pharmaceutical dosage form according to claim 5 , further comprises a lubricant.
9 . The solid pharmaceutical dosage form according to claim 8 , wherein the lubricant is magnesium stearate.
10 . The solid pharmaceutical dosage form according to claim 5 , wherein the solid pharmaceutical dosage form comprises a sustained release polymer.
11 . The solid pharmaceutical dosage form according to 10 , wherein the sustained release polymer is an acrylate polymer or copolymer, a methyl cellulose, or a combination thereof.
12 . The solid pharmaceutical dosage form according to claim 1 , wherein the solid pharmaceutical dosage form is a tablet or capsule.
13 . The solid pharmaceutical dosage form according to claim 12 , wherein the solid pharmaceutical dosage form is a bilayer tablet.
14 . A solid pharmaceutical dosage form comprising about 105 mg of bupropion hydrochloride, and about 60 mg to about 95 mg of L-Cysteine hydrochloride monohydrate, and wherein the solid pharmaceutical dosage form has a molar ratio of the bupropion to the cysteine that is about 0.7:1 to about 1.1:1, wherein the solid pharmaceutical dosage form further comprises dextromethorphan hydrobromide, and wherein the bupropion and the dextromethorphan are the only therapeutic active agents in the dosage form.
15 . The solid pharmaceutical dosage form according to claim 14 , wherein the solid pharmaceutical dosage form comprises about 60 mg to about 80 mg of L-Cysteine hydrochloride monohydrate.
16 . The solid pharmaceutical dosage form according to claim 14 , wherein the solid pharmaceutical dosage form comprises about 60 mg to about 70 mg of L-Cysteine hydrochloride monohydrate.
17 . The solid pharmaceutical dosage form according to claim 14 , wherein the solid pharmaceutical dosage form comprises about 70 mg to about 80 mg of L-Cysteine hydrochloride monohydrate.
18 . The solid pharmaceutical dosage form according to claim 14 , wherein the solid pharmaceutical dosage form comprises about 30 mg to about 60 mg of dextromethorphan, or a molar equivalent of a pharmaceutically acceptable salt thereof.