DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION
This disclosure relates to dosage forms containing an enantiomerically enriched or pure bupropion such as enantiomeric excess of (S)-bupropion, enantiomerically enriched (S)-bupropion, or enantiomerically pure (S)-bupropion and methods of using these dosage forms. These dosage forms may be administered to human beings in a reduced amount as compared to the amount of racemic bupropion that would be administered in the same situation.
1 . A dosage form comprising about 90 mg to about 100 mg of the free base form of (S)-bupropion that is at least 95% enantiomerically pure, or a molar equivalent amount of a salt form of (S)-bupropion that is at least 95% enantiomerically pure.
2 . The dosage form of claim 1 , wherein the (S)-bupropion is at least 97% enantiomerically pure.
3 . The dosage form of claim 1 , wherein the (S)-bupropion is at least 99% enantiomerically pure.
4 . The dosage form of claim 1 , wherein the (S)-bupropion is in the salt form.
5 . The dosage form of claim 1 , wherein the (S)-bupropion is in the free base form.
6 . The dosage form of claim 1 , wherein the dosage form provides sustained release of the (S)-bupropion.
7 . The dosage form of claim 1 , wherein the dosage form is free of dextromethorphan.
8 . The dosage form of claim 1 , wherein the dosage form is free of any other active pharmaceutical agent other than any (R)-bupropion that is present when the (S)-bupropion is less than 100% enantiomerically pure.
9 . The dosage form of claim 1 , further comprising microcrystalline cellulose.
10 . The dosage form of claim 1 , further comprising hydroxypropyl methylcellulose.
11 . The dosage form of claim 1 , further comprising a binder.
12 . The dosage form of claim 1 , further comprising a disintegrating agent.
13 . The dosage form of claim 1 , further comprising a lubricant.
14 . The dosage form of claim 1 , further comprising magnesium stearate.
15 . The dosage form of claim 1 , further comprising a coating.
16 . The dosage form of claim 1 , further comprising sucrose.
17 . The dosage form of claim 1 , further comprising lactose.
18 . The dosage form of claim 1 , in the form of a tablet.
19 . The dosage form of claim 1 , in the form of a pill.
20 . The dosage form of claim 1 , in the form of a capsule.
21 . The dosage form of claim 1 , wherein the dosage form is formulated for administration once or twice daily.