Compositions and methods for increasing the metabolic lifetime of dextromethorphan and related pharmacodynamic effects
First Claim
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1. A method of increasing dextromethorphan plasma levels in a human being that is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, comprising:
- administering, once or twice a day to the human being, a combination of active agents comprising;
1) bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion; and
2) dextromethorphan;
wherein the combination of active agents is administered for at least 8 consecutive days;
wherein about 40 mg to about 600 mg of dextromethorphan is administered per day;
wherein administering the combination of active agents results in an AUC0-12 of dextromethorphan, on the eighth day, that is at least about 400 ng·
hr/mL; and
wherein administering the combination of active agents results in a Cmax of dextromethorphan, on the eighth day, that is at least 15 times the Cmax of dextromethorphan that would result from administering the same amount of dextromethorphan without bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion for eight consecutive days.
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Abstract
This disclosure relates to methods of increasing dextromethorphan plasma levels comprising co-administering hydroxybupropion, or a prodrug thereof, and dextromethorphan to a human being in need of treatment with dextromethorphan. Dosage forms, drug delivery systems, and methods related to dextromethorphan and hydroxybupropion or a prodrug of bupropion are also disclosed.
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Citations
19 Claims
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1. A method of increasing dextromethorphan plasma levels in a human being that is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, comprising:
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administering, once or twice a day to the human being, a combination of active agents comprising; 1) bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion; and 2) dextromethorphan; wherein the combination of active agents is administered for at least 8 consecutive days; wherein about 40 mg to about 600 mg of dextromethorphan is administered per day; wherein administering the combination of active agents results in an AUC0-12 of dextromethorphan, on the eighth day, that is at least about 400 ng·
hr/mL; andwherein administering the combination of active agents results in a Cmax of dextromethorphan, on the eighth day, that is at least 15 times the Cmax of dextromethorphan that would result from administering the same amount of dextromethorphan without bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion for eight consecutive days. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of increasing dextromethorphan plasma levels in a human being that is an extensive metabolizer of dextromethorphan in need of treatment with dextromethorphan, comprising:
administering, once or twice a day to the human being, a combination of active agents comprising; 1) bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion; and 2) dextromethorphan; wherein the combination of active agents is administered for at least 8 consecutive days; wherein about 40 mg to about 600 mg of dextromethorphan is administered per day; wherein administering the combination of active agents results in a Cmax of dextromethorphan, on the eighth day, that is at least about 40 ng/mL; and wherein administering the combination of active agents results in an AUC0-12 of dextromethorphan, on the eighth day, that is at least 15 times the AUC0-12 of dextromethorphan that would result from administering the same amount of dextromethorphan without bupropion, hydroxybupropion, erythrohydroxybupropion, or threohydroxybupropion for eight consecutive days. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
Specification