Antidepressant dosage form

Abstract

The invention pertains to a dosage form 10 and to administering an antidepressant medicament 16 for an extended period of time in a rate-known dose.

We claim:  
     
         1 . A therapeutic composition comprising 0.5 mg to 750 mg of a drug of the formula:  
       
         
           
           
               
               
           
         
       
       wherein the dotted line represents an unsaturation or a cycloalkenyl group; R 1  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 2  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 4  is a member selected from the group consisting of hydrogen, alkyl of 1 to 6 carbon atoms, formyl, and alkanoyl of 2 to 7 carbon atoms; R 5  and R 6  are independently a member selected from the group consisting of hydrogen, hydroxyl, an alkyl of 1 to 6 carbon atoms, an alkoxy of 1 to 6 carbon atoms, alkanoyloxy of 2 to 7 carbon atoms, nitro, alkylmercapto of 1 to 6 carbon atoms, amino, alkylamino of 1 to 6 carbon atoms in which each alkyl group comprises 1 to 6 carbon atoms, alkanamide of 2 to 7 carbon atoms, halo, and trifluoroethyl, R 7  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbons, and n is one of the integers 0, 1, 2, 3, and 4, and a pharmaceutically acceptable addition salt; and wherein the drug of the formula is blended with a poly(alkylene oxide) polymer.  
     
     
         2 . A therapeutic composition comprising 0.5 mg to 750 mg of a drug of the formula;  
       
         
           
           
               
               
           
         
       
       wherein the dotted line represents an unsaturation or a cycloalkenyl group; R 1  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 2  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 4  is a member selected from the group consisting of hydrogen, alkyl of 1 to 6 carbon atoms, formyl, and alkanoyl of 2 to 7 carbon atoms; R 5  and R 6  are independently a member selected from the group consisting of hydrogen, hydroxyl, an alkyl of 1 to 6 carbon atoms, an alkoxy of 1 to 6 carbon atoms, alkanoyloxy of 2 to 7 carbon atoms, nitro, alkylmercapto of 1 to 6 carbon atoms, amino, alkylamino of 1 to 6 carbon atoms in which each alkyl group comprises 1 to 6 carbon atoms, alkanamido of 2 to 7 carbon atoms, halo, and trifluoroethyl; R 7  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbons and n is one of the integers 0, 1, 2, 3, 4, and a pharmaceutically acceptable addition salt; and wherein the drug of the formula is blended with a cellulose polymer.  
     
     
         3 . A therapeutic composition comprising 0.5 mg to 750 mg of a drug of the formula:  
       
         
           
           
               
               
           
         
       
       wherein the dotted line represents an unsaturation or a cycloalkenyl group; R 1  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 2  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 4  is a member selected from the group consisting of hydrogen, alkyl of 1 to 6 carbon atoms, formyl, and alkanoyl of 2 to 7 carbon atoms; R 5  and R 6  are independently a member selected from the group consisting of hydrogen, hydroxyl, an alkyl of 1 to 6 carbon atoms, an alkoxy of 1 to 6 carbon atoms, alkanoyloxy of 2 to 7 carbon atoms, nitro, alkylmercapto of 1 to 6 carbon atoms, amino, alkylamino of 1 to 6 carbon atoms in which each alkyl group comprises 1 to 6 carbon atoms, alkanamido of 2 to 7 carbon atoms, halo, and trifluoroethyl, R 7  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbons, and n is one of the integers 0, 1, 2, 3, and 4; and a pharmaceutically acceptable addition salt; and wherein the drug of the formula is blended with a maltodextrin polymer.  
     
     
         4 . A method for administering a drug to the gastrointestinal tract of an animal, wherein the method comprises: 
 (a) admitting orally into the animal a dosage form comprising a drug of the formula:                          which drug possesses antidepressant therapy and the dosage form comprises a member selected from the group consisting of a sustained-release dosage form and a controlled-release dosage form; and,    (b) administering the drug from the dosage form over an extended period of time in a therapeutically responsive dose to produce the antidepressant therapy.    
     
     
         5 . A dosage form for administering a drug to an environment of use, wherein the dosage form comprises a drug of the formula:  
       
         
           
           
               
               
           
         
       
       which dosage form comprises a member selected from the group consisting of a sustained-release dosage form and a controlled release dosage form, and wherein said dosage form comprises means for storing the drug and means for releasing the drug over an extended period of time.  
     
     
         6 . A dosage form for the oral delivery of a drug to an environment of use, wherein the dosage form comprises: 
 (a) a wall comprising at least in part a composition permeable to the passage of fluid, which wall surrounds:    (b) a compartment;    (c) a drug composition in the compartment comprising a drug of the formula:                          wherein the dotted line represents a member selected from the group consisting of an unsaturation and cycloalkenyl group; R 1  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 2  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbon atoms; R 4  is a member selected from the group consisting of hydrogen, alkyl of 1 to 6 carbon atoms, formyl, and alkanoyl of 2 to 7 carbon atoms; R 5  and R 6  are independently a member selected from the group consisting of hydrogen, hydroxyl and alkyl of 1 to 6 carbon atoms, alkoxy of 1 to 6 carbon atoms, alknaoyloxy of 2 to 7 carbon atoms, nitro, alkylmercapto of 1 to 6 carbon atoms, amino, alkylamino of 1 to 6 carbon atoms, alkanamido of 2 to 7 carbon atoms, halo and trifluoroethyl; R 7  is a member selected from the group consisting of hydrogen and alkyl of 1 to 6 carbons; an n is 0 to 4; and    (d) a displacement in the compartment comprising a composition comprising an osmotically active compound; and,    (e) an exit passageway in the dosage form for delivering the drug composition from the dosage form.    
     
     
         7 . A dosage form for the oral delivery of the drug to an environment of use according to  claim 6 , wherein the drug is 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-cyclohexanol.