Formulations of (r)-2-amino-3-phenylpropyl carbamate

Abstract

The present invention relates to immediate release formulations of (R)-2-amino-3-phenylpropyl carbamate and methods of using the same to treat disorders.

1 - 40 . (canceled) 
     
     
         41 . An oral dosage form for delivery of (R)-2-amino-3-phenylpropyl carbamate, the oral dosage form comprising (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof in an amount of about 90-98% by weight of the oral dosage form;
 wherein the oral dosage form exhibits substantially identical dissolution rates of the (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof at pH 1.2, pH 4.5, and pH 6.8.   
     
     
         42 . The oral dosage form of  claim 41 , wherein the oral dosage form is a tablet. 
     
     
         43 . The oral dosage form of  claim 41 , wherein the oral dosage form is a compressed tablet. 
     
     
         44 . The oral dosage form of  claim 42 , wherein the tablet is oblong in shape. 
     
     
         45 . The oral dosage form of  claim 41 , wherein the oral dosage form is a capsule. 
     
     
         46 . The oral dosage form of  claim 41 , wherein the oral dosage form releases at least 85% of the (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof contained therein within a period of less than 15 minutes after administration of the oral dosage form to a subject. 
     
     
         47 . The oral dosage form of  claim 41 , wherein the oral dosage form releases at least 95% of the (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof contained therein within a period of less than 15 minutes after administration of the oral dosage form to a subject. 
     
     
         48 . The oral dosage form of  claim 41 , wherein the oral dosage form does not comprise a disintegrant. 
     
     
         49 . The oral dosage form of  claim 41 , wherein the oral dosage form comprises:
 (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof in an amount of about 90-98% by weight of the oral dosage form;   at least one binder in an amount of about 1-5% by weight of the oral dosage form; and   at least one lubricant in an amount of about 0.1-2% by weight of the oral dosage form.   
     
     
         50 . The oral dosage form of  claim 49 , wherein the at least one binder is selected from at least one of hydroxypropyl cellulose, ethylcellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, hydroxyethyl cellulose, povidone, copovidone, pregelatinized starch, dextrin, gelatin, maltodextrin, starch, zein, acacia, alginic acid, carbomers (cross-linked polyacrylates), polymethacrylates, sodium carboxymethylcellulose, guar gum, hydrogenated vegetable oil (type 1), methylcellulose, magnesium aluminum silicate, and sodium alginate. 
     
     
         51 . The oral dosage form of  claim 49 , wherein the at least one binder is selected from at least one of hydroxypropyl cellulose, hydroxypropyl methylcellulose, and povidone. 
     
     
         52 . The oral dosage form of  claim 49 , wherein the at least one lubricant is selected from at least one of magnesium stearate, stearic acid, calcium stearate, hydrogenated castor oil, hydrogenated vegetable oil, light mineral oil, magnesium stearate, mineral oil, polyethylene glycol, sodium benzoate, sodium stearyl fumarate, and zinc stearate. 
     
     
         53 . The oral dosage form of  claim 49 , wherein the at least one lubricant is selected from at least one of magnesium stearate, calcium stearate, and sodium stearyl fumarate. 
     
     
         54 . The oral dosage form of  claim 41 , comprising:
 (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof in an amount of about 90-98% by weight of the oral dosage form;   hydroxypropyl cellulose in an amount of about 1-5% by weight of the oral dosage form; and   magnesium stearate in an amount of about 0.1-2% by weight of the oral dosage form.   
     
     
         55 . The oral dosage form of  claim 41 , further comprising a coating. 
     
     
         56 . The oral dosage form of  claim 55 , wherein the coating is a color overcoat. 
     
     
         57 . The oral dosage form of  claim 41 , wherein the (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof is (R)-2-amino-3-phenylpropyl carbamate hydrochloride. 
     
     
         58 . The oral dosage form of  claim 41 , wherein the oral dosage form comprises about 300 mg (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof. 
     
     
         59 . The oral dosage form of  claim 41 , wherein the oral dosage form comprises about 150 mg (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof. 
     
     
         60 . The oral dosage form of  claim 41 , wherein the oral dosage form comprises about 75 mg (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof. 
     
     
         61 . The oral dosage form of  claim 41 , wherein the oral dosage form comprises about 37.5 mg (R)-2-amino-3-phenylpropyl carbamate or a pharmaceutically acceptable salt thereof. 
     
     
         62 . A method of treating narcolepsy, cataplexy, excessive daytime sleepiness, drug addiction, sexual dysfunction, fatigue, fibromyalgia, attention deficit/hyperactivity disorder, restless legs syndrome, depression, bipolar disorder, or obesity in a subject in need thereof, or promoting smoking cessation in a subject in need thereof, comprising administering to the subject the oral dosage form of  claim 41 . 
     
     
         63 . The method of  claim 62 , wherein the oral dosage form is administered once per day. 
     
     
         64 . The method of  claim 62 , wherein the oral dosage form is administered more than once per day. 
     
     
         65 . The method of  claim 62 , wherein the subject is human.