Methods and compositions for treating depression and other disorders using optically pure (-)-bupropion

Abstract

Methods and compositions are disclosed utilizing the optically pure (−)-isomer of bupropion, which is a potent drug for treating depression, Parkinson's disease, obesity, weight gain and other disorders.

What is claimed is:  
     
         1 . A method of treating depression in a human while avoiding the concomitant liability of adverse effects associated with administration of racemic bupropion, which comprises administering to a human in need of antidepressant therapy, a therapeutically effective amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer.  
     
     
         2 . The method of  claim 1  wherein said amount is sufficient to alleviate said depression, but insufficient to cause said adverse effects associated with administration of racemic bupropion.  
     
     
         3 . The method of  claim 1  wherein (−)-bupropion is administered intravenously, transdermally or orally.  
     
     
         4 . The method of  claim 3  wherein (−)-bupropion is administered orally as a tablet or a capsule.  
     
     
         5 . The method of  claim 1  wherein the amount administered is from about 10 mg to about 750 mg.  
     
     
         6 . The method of  claim 5  wherein the amount administered is from about 50 mg to about 600 mg.  
     
     
         7 . The method of  claim 6  wherein the amount administered is from about 60 mg to about 450 mg.  
     
     
         8 . The method of  claim 1  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof is greater than approximately 90% by weight of the total amount of bupropion.  
     
     
         9 . The method of  claim 1  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer is administered together with a pharmaceutically acceptable carrier.  
     
     
         10 . The method according to  claim 1  wherein (−)-bupropion is administered as the hydrochloride salt.  
     
     
         11 . The method of  claim 1  wherein (−)-bupropion is administered in a sustained or controlled release formulation.  
     
     
         12 . A method of treating Parkinson's disease in a human while avoiding the concomitant liability of adverse effects associated with the administration of racemic bupropion, which comprises administering to said human in need of treatment for Parkinson's disease, a therapeutically effective amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer.  
     
     
         13 . The method of  claim 12  wherein said amount is sufficient to alleviate said Parkinson's disease, but insufficient to cause said adverse effects associated with administration of racemic bupropion.  
     
     
         14 . The method of  claim 12  wherein (−)-bupropion is administered by intravenously, transdermally, or orally.  
     
     
         15 . The method of  claim 14  wherein (−)-bupropion is administered orally as a tablet or a capsule.  
     
     
         16 . The method of  claim 12  wherein the amount administered is from about 10 mg to about 750 mg.  
     
     
         17 . The method of  claim 16  wherein the amount administered is from about 50 mg to about 600 mg.  
     
     
         18 . The method of  claim 17  wherein the amount administered is from about 60 mg to about 450 mg.  
     
     
         19 . The method of  claim 12  wherein the amount of (−) -bupropion or a pharmaceutically -acceptable salt thereof is greater than approximately 90% by weight of the total amount of bupropion.  
     
     
         20 . The method of  claim 12  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer, is administered together with a pharmaceutically acceptable carrier.  
     
     
         21 . The method according to  claim 12  wherein (−)-bupropion is administered as the hydrochloride salt.  
     
     
         22 . The method of  claim 12  wherein (−)-bupropion is administered in a sustained or controlled release formulation.  
     
     
         23 . A method for treating obesity or weight gain in a human which comprises administering to a human in need of weight reduction or weight control a therapeutically effective amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer.  
     
     
         24 . The method of  claim 23  wherein said amount is sufficient to alleviate obesity or weight gain, but insufficient to cause adverse effects associated with administration of racemic bupropion.  
     
     
         25 . The method of  claim 23  wherein (−)-bupropion is administered by intravenously, transdermally, or orally.  
     
     
         26 . The method of  claim 25  wherein (−)-bupropion is administered orally as a tablet or a capsule.  
     
     
         27 . The method of  claim 23  wherein the amount administered is from about 10 mg to about 750 mg.  
     
     
         28 . The method of  claim 27  wherein the amount administered is from about 50 mg to about 600 mg.  
     
     
         29 . The method of  claim 28  wherein the amount administered is from about 60 mg to about 450 mg.  
     
     
         30 . The method of  claim 23  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof is greater than approximately 90% by weight of the total amount of bupropion.  
     
     
         31 . The method of  claim 23  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer, is administered together with a pharmaceutically acceptable carrier.  
     
     
         32 . The method according to  claim 23  wherein (−)-bupropion is administered as the hydrochloride salt.  
     
     
         33 . The method of  claim 23  wherein (−)-bupropion is administered in a sustained release or controlled release formulation.  
     
     
         34 . A method of treating a disorder selected from the group consisting of bipolar disorders, attention-deficit disorders, conduct disorders, psycho-sexual dysfunction, bulimia, eating disorders and specific food craving which comprises administering to a human suffering from said disorder a therapeutically effective amount of (−)-bupropion, or a pharmaceutically acceptable salt therefore, substantially free of its (+)-stereoisomer.  
     
     
         35 . The method of  claim 34  wherein (−)-bupropion is administered by intravenously, transdermally, or orally.  
     
     
         36 . The method of  claim 35  wherein (−)-bupropion is administered orally as a tablet or a capsule.  
     
     
         37 . The method of  claim 34  wherein the amount administered is from about 10 mg to about 750 mg.  
     
     
         38 . The method of  claim 37  wherein the amount administered is from about 50 mg to about 600 mg.  
     
     
         39 . The method of  claim 38  wherein the amount administered is from about 60 mg to about 450 mg.  
     
     
         40 . The method of  claim 34  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof is greater than approximately 90% by weight of the total amount of bupropion.  
     
     
         41 . The method of  claim 34  wherein the amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer, is administered together with a pharmaceutically acceptable carrier.  
     
     
         42 . The method according to  claim 34  wherein (−)-bupropion is administered as the hydrochloride salt.  
     
     
         43 . The method of  claim 34  wherein (−)-bupropion is administered in a controlled or sustained release formulation.  
     
     
         44 . A pharmaceutical composition which comprises a therapeutically amount of (−)-bupropion or a pharmaceutically acceptable salt thereof, substantially free of its (+)-stereoisomer, and a pharmaceutically acceptable carrier.  
     
     
         45 . The composition according to  claim 44  wherein the amount is about 10 mg to about 750 mg.  
     
     
         46 . The composition according to  claim 44  which comprises (−)-bupropion hydrochloride.  
     
     
         47 . The composition according to  claim 46  wherein said composition is adapted for oral administration.  
     
     
         48 . The composition according to  claim 46  adapted for intravenous delivery.  
     
     
         49 . The composition according to  claim 46  for use in a transdermal formulation.  
     
     
         50 . The composition according to  claim 46  for use as a transdermal patch.  
     
     
         51 . The composition of  claim 46  wherein said composition is a solid preparation.  
     
     
         52 . A sustained release formulation which comprises (−)-bupropion or a pharmaceutically acceptable salt thereof substantially free of its (+)-stereoisomer, and a pharmaceutically acceptable carrier.  
     
     
         53 . The sustained release formulation of  claim 52  wherein said formulation is a tablet, capsule or gelcap.