Formulations, salts and polymorphs of transnorsertraline and uses thereof

Abstract

Provided herein are pharmaceutical compositions comprising transnorsertraline, salts and polymorphic forms of transnorsertraline, methods of making the compositions, and methods for their use for the treatment of CNS diseases, including depression.

1 .- 71 . (canceled) 
     
     
         72 . A method of treating, preventing, or managing a neurological disorder comprising administering to a patient a pharmaceutical composition comprising:
 (a) about 0.5 mg to about 2.5 mg of a compound   
       
         
           
           
               
               
           
         
         (b) mannitol or xylitol; and 
         (c) one or more of
 (i) a disintegrant; 
 (ii) a lubricant; and 
 (iii) an anti-caking agent. 
 
       
     
     
         73 . The method of  claim 72  wherein the pharmaceutical composition is a solid oral dosage form. 
     
     
         74 . The method of  claim 73  wherein the solid oral dosage form is a tablet or a capsule. 
     
     
         75 . The method of  claim 72  wherein the mannitol or xylitol is mannitol, said mannitol containing less than 0.1% by weight of mannose. 
     
     
         76 . The method of  claim 75  wherein the pharmaceutical composition comprises at least 10% to 90% by weight of mannitol. 
     
     
         77 . The method of  claim 72  wherein the disintegrant is croscarmellose sodium or sodium starch glycolate. 
     
     
         78 . The method of  claim 72  wherein the lubricant is magnesium stearate, calcium stearate, zinc stearate, or steric acid. 
     
     
         79 . The method of  claim 72  wherein the anti-caking agent is talc, kaolin, or bentonite. 
     
     
         80 . The method of  claim 72  wherein the pharmaceutical composition comprises about 0.56 mg of the compound. 
     
     
         81 . The method of  claim 72  wherein the pharmaceutical composition comprises about 1.13 mg of the compound. 
     
     
         82 . The method of  claim 72  wherein the pharmaceutical composition comprises about 2.25 mg of the compound. 
     
     
         83 . The method of  claim 72  wherein the neurological disorder is depression, cognitive deficits, fibromyalgia, pain, a sleep related disorder, chronic fatigue syndrome, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), restless leg syndrome, schizophrenia, anxiety, obsessive compulsive disorder, posttraumatic stress disorder, seasonal affective disorder (SAD), premenstrual dysphoria, post-menopausal vasomotor symptoms, a neurodegenerative disease, manic conditions, dysthymic disorder, cyclothymic disorder, obesity, substance abuse or dependency, anorexia nervosa, bulimia, or binge eating. 
     
     
         84 . The method of  claim 83  wherein the neurological disorder is attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), or binge eating.