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, comprising:
orally administering a daily dose of an (S)-bupropion to a human being in need thereof which is about 120 mg to about 210 mg, wherein the (S)-bupropion is not deuterium-enriched;
wherein the (S)-bupropion is at least 95% enantiomerically pure, and no other bupropion is orally administered with the daily dose of the (S)-bupropion;
wherein the (S)-bupropion is in a dosage form, and wherein the dosage form contains less than 0.1% of any active pharmaceutical agent or drug other than the (S)-bupropion; and
wherein the (S)-bupropion is orally administered once or twice daily.
2. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 8 consecutive days.
3. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 14 consecutive days.
4. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 21 consecutive days.
5. The method of claim 1 , wherein the dosage form provides sustained release of the (S)-bupropion.
6. 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.
7. 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.
8. The method of claim 1 , 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.
9. The method of claim 1 , wherein the dosage form is in a form of tablet, capsule, or syrup.
10. The method of claim 1 , wherein the dosage form is a solid oral dosage form.
11. The method of claim 1 , wherein the dosage form is orally administered to the human being under fasting conditions.
12. The method of claim 1 , wherein the (S)-bupropion is at least 97% enantiomerically pure.
13. The method of claim 1 , wherein the (S)-bupropion is at least 99% enantiomerically pure.
14. The method of claim 1 , wherein the (S)-bupropion is in a salt form.
15. The method of claim 1 , wherein the (S)-bupropion is in the free base form.
16. The method of claim 1 , which is effective in providing a therapeutic effect on the attention deficit/hyperactivity disorder.
17. The method of claim 1 , wherein orally administering the daily dose of the (S)-bupropion to the human being results in a reduction of adverse events associated with racemic bupropion.