Pharmaceutical compositions containing lithium carbonate

Abstract

Once daily pharmaceutical compositions containing lithium carbonate in the form of coated granules.

1 - 5 . (canceled)  
     
     
         6 . A pharmaceutical composition containing an amount of lithium carbonate from 300 mg to 900 mg, in the form of coated granules having the following composition: 
 93% to (150/1.61) % lithium carbonate and further containing ethylcellulose, talc, and polyvinylpyrrolidone.    
     
     
         7 . The composition of  claim 6  wherein said granules have the following composition: 
 93% to (150/1.61) % lithium carbonate;    (2.575/1.61) % to 1.7% ethylcellulose;    (1.125/1.61) % to 0.8% talc; and    4.5% to (7.300/1.61) % polyvinylpyrrolidone.    
     
     
         8 . The composition of  claim 6  wherein said amount of lithium carbonate is selected from the group consisting of 300 mg, 450 mg, and 600 mg.  
     
     
         9 . The composition of  claim 6  wherein said granules have the following composition: 
 93% lithium carbonate;    1.7% ethylcellulose;    0.8% talc; and    4.5% polyvinylpyrrolidone.    
     
     
         10 . The composition of  claim 6  wherein said granules have the following composition: 
 (150/1.61) % lithium carbonate;    (2.575/1.61) % ethylcellulose;    (1.125/1.61) % talc; and    (7.300/1.61 ) % polyvinylpyrrolidone.    
     
     
         11 . The composition of  claim 6  wherein said granules are contained in a gelatin capsule.  
     
     
         12 . A controlled release dosage formulation for suitable for once-a-day administration to a human patient, comprising coated granules of lithium carbonate, said granules comprising at least 93% of lithium carbonate, wherein administration of a said formulation once daily to said patient results in a substantially constant plasma concentration of lithium for 24 hours.  
     
     
         13 . The controlled release dosage formulation of  claim 12 , said dosage unit containing said lithium carbonate in the form of a plurality of coated granules, said granules comprising, in addition to said lithium carbonate, at least each of ethyl cellulose, talc, and polyvinylpyrrolidone.  
     
     
         14 . The controlled release dosage formulation of  claim 13 , wherein said granules have a formulation which is 93% to (150/1.61) % lithium carbonate.  
     
     
         15 . The controlled release dosage formulation of  claim 13 , wherein said granules have a formulation which is 
 93% to (150/1.61) % lithium carbonate;    (2.575/1.61) % to 1.7% ethylcellulose;    (1.125/1.61) % to 0.8% talc; and    4.5% to (7.300/1.61) % polyvinylpyrrolidone.    
     
     
         16 . The formulation of  claim 6  which provides a substantially constant release rate of lithium carbonate over a period of 24 hours to produce a plasma concentration of lithium that varies by no more than about 25% over 24 hours.  
     
     
         17 . The formulation of  claim 12  wherein said the coating of said coated granules comprises ethylcellulose.  
     
     
         18 . The formulation of  claim 6  wherein said coated granules are from about 840 microns to about 1340 microns in diameter.  
     
     
         19 . The formulation of  claim 12  wherein said coated granules are from about 840 microns to about 1340 microns in diameter.  
     
     
         20 . The formulation of  claim 6  wherein upon administration of said formulation to a patient, said lithium carbonate is released so as to produce a plasma concentration in said patient of at least 0.35 mEq/L over 24 hours.  
     
     
         21 . The formulation of  claim 12  wherein upon administration of said formulation to a patient, said lithium carbonate is released so as to produce a plasma concentration in said patient of at least 0.35 mEq/L over 24 hours.  
     
     
         22 . A method of treating a condition selected from the group consisting of depressive and manic disorders, psychosis, cephalalgia, medicament leukopenia, hemopoietic diseases, immunologic diseases, tumors, and AIDS in a patient having said condition comprising administering an effective amount for the treatment of said condition of the composition of  claim 6  to said patient.  
     
     
         23 . A method of treating a condition selected from the group consisting of depressive and manic disorders, psychosis, cephalalgia, medicament leukopenia, hemopoietic diseases, immunologic diseases, tumors, and AIDS in a patient having said condition comprising administering an effective amount for the treatment of said condition of the composition of  claim 12  to said patient.  
     
     
         24 . The method of  claim 22  wherein said administration is once daily.  
     
     
         25 . The method of  claim 23  wherein said administration is once daily.  
     
     
         26 . A method of manufacture of a dosage form of  claim 6  comprising (a) granulating lithium carbonate with an aqueous solution of polyvinylpyrrolidone to result in a first granulate; (b) sieving said first granulate; (c) drying the result of step b to give a first dried product; (c) coating said first dried product with an additional aliquot of said aqueous solution of polyvinylpyrrolidone and additional lithium carbonate to result in a second granulate; (d) sieving said second granulate; (e) drying said second granulate to result in a second dried product; (f) coating said second dried product with ethylcellulose, said talc being added in fractions after each ethylcellulose coating cycle.  
     
     
         27 . A method of manufacture of a dosage form of  claim 13  comprising (a) granulating lithium carbonate with an aqueous solution of polyvinylpyrrolidone to result in a first granulate; (b) sieving said first granulate; (c) drying the result of step b to give a first dried product; (c) coating said first dried product with an additional aliquot of said aqueous solution of polyvinylpyrrolidone and additional lithium carbonate to result in a second granulate; (d) sieving said second granulate; (e) drying said second granulate to result in a second dried product; (f) coating said second dried product with ethylcellulose, said talc being added in fractions after each ethylcellulose coating cycle.