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 method of treating attention deficit/hyperactivity disorder in a human being comprising orally administering a dosage form containing (S)-bupropion that is at least 95% enantiomerically pure, one or two times per day, to the human being, wherein the (S)-bupropion is not deuterium-enriched, wherein the human being is in need of treatment with (S)-bupropion, wherein (R,R)-hydroxybupropion is at least 97% of the total amount of (R,R)-hydroxybupropion and (S,S)-hydroxybupropion present in the plasma of the human being, wherein a daily dose of the (S)-bupropion that is about 60 mg to about 180 mg is orally administered to the human being, wherein the method is effective in treating attention deficit/hyperactivity disorder, and wherein the dosage form contains less than 0.1% of any active pharmaceutical agent or drug other than the (S)-bupropion.
2. The method of claim 1 , wherein the dosage form is orally administered once daily.
3. The method of claim 2 , wherein the dosage form contains about 150 mg to about 180 mg of the (S)-bupropion.
4. The method of claim 1 , wherein the dosage form is orally administered twice daily.
5. The method of claim 4 , wherein the dosage form contains about 70 mg to about 80 mg of the (S)-bupropion.
6. The method of claim 1 , wherein the dosage form is orally administered for at least 8 consecutive days.
7. The method of claim 1 , wherein the dosage form is orally administered for at least 14 consecutive days.
8. The method of claim 1 , wherein the dosage form is orally administered for at least 21 consecutive days.
9. The method of claim 8 , wherein the method achieves a C max of (S)-bupropion in the human being that is about 60 ng/mL to about 140 ng/mL.
10. The method of claim 1 , wherein the dosage form is orally administered for at least 28 consecutive days.
11. The method of claim 1 , wherein the method achieves an AUC 0-12 of (S)-bupropion in the human being that is at least about 400 ng·hr/mL.
12. The method of claim 1 , wherein the method achieves an AUC 0-12 of (S)-bupropion in the human being that is about 500 ng·hr/mL to about 900 ng·hr/mL.
13. The method of claim 1 , wherein the dosage form provides sustained release of (S)-bupropion.
14. The method of claim 1 , wherein a daily dose of the (S)-bupropion that is about 60 mg to about 120 mg is orally administered to the human being.
15. The method of claim 1 , wherein a daily dose of the (S)-bupropion that is about 80 mg to about 150 mg is orally administered to the human being.
16. The method of claim 1 , wherein a daily dose of the (S)-bupropion that is about 100 mg to about 180 mg is orally administered to the human being.
17. The method of claim 1 , wherein a daily dose of the (S)-bupropion that is about 120 mg to about 180 mg is orally administered to the human being.