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 (AD/HD) comprising orally administering an (S)-bupropion that is at least 95% enantiomerically pure to a human being in need thereof, wherein the (S)-bupropion is not deuterium-enriched, wherein the (S)-bupropion is administered once or twice daily for a total dose of about 20 mg per day to about 210 mg per day of the (S)-bupropion and is therapeutically effective for treating AD/HD, wherein the (S)-bupropion that is at least 95% enantiomerically pure is orally administered in a dosage form that includes the (S)-bupropion that is at least 95% enantiomerically pure and 5% or less of (R)-bupropion, and is free of any active pharmaceutical ingredients other than the (S)-bupropion and, if present, the (R)-bupropion.
2. The method of claim 1 , wherein the human being has an age of about 18 years or less.
3. The method of claim 1 , wherein the dosage form contains a binder.
4. The method of claim 1 , wherein the dosage form contains an excipient.
5. The method of claim 1 , wherein the dosage form contains a disintegrating agent.
6. The method of claim 1 , wherein the dosage form contains a lubricant.
7. The method of claim 1 , wherein the method achieves a C max of (S)-bupropion in the human being that is at least about 60 ng/mL.
8. The method of claim 1 , wherein the method is effective in achieving a C max of (S)-bupropion that is at least 5-fold greater than the C max of (R)-bupropion that results from orally administering the same amount of (R)-bupropion to the human being.
9. The method of claim 1 , wherein the method achieves a C max of (R,R)-hydroxybupropion that is at least about 500 ng/mL in the human being.
10. The method of claim 1 , wherein the method is effective in achieving a C min of (R,R)-hydroxybupropion that is at least 3-fold greater than the C min of (R,R)-hydroxybupropion that results from orally administering the same amount of (R)-bupropion to the human being.
11. The method of claim 1 , wherein orally administering the (S)-bupropion results in (R,R)-hydroxybupropion that is at least 97% of the total amount of hydroxybupropion present in the plasma of the human being.
12. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 8 consecutive days.
13. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 14 consecutive days.
14. The method of claim 1 , wherein the (S)-bupropion is orally administered for at least 21 consecutive days.
15. The method of claim 1 , wherein the dosage form provides sustained release of (S)-bupropion.
16. The method of claim 1 , wherein the method achieves a C max of (R,R)-hydroxybupropion in the human being that is at least about 600 ng/mL.
17. The method of claim 1 , wherein the dosage form is in a form of tablet, capsule, or syrup.
18. The method of claim 1 , wherein the dosage form is orally administered to the human being under fasting conditions.
19. The method of claim 1 , wherein the (S)-bupropion is at least 97% enantiomerically pure.
20. The method of claim 1 , wherein the (S)-bupropion is at least 99% enantiomerically pure.
21. The method of claim 1 , wherein the (S)-bupropion is in a salt form.
22. The method of claim 1 , wherein the (S)-bupropion is in the free base form.