Pharmaceutical compositions containing lithium carbonate

Abstract

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

1 - 5 . (canceled) 
     
     
         6 . 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 a pharmaceutical composition to said patient, said 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 method 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 method 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 method 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 method 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 method of  claim 6  wherein said granules are contained in a gelatin capsule. 
     
     
         12 . 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 a pharmaceutical composition to said patient, said pharmaceutical composition being 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 method of  claim 12 , said dosage formulation 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 method of  claim 13 , wherein said granules have a formulation which is 93% to (150/1.61) % lithium carbonate. 
     
     
         15 . The method 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 method 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 method of  claim 12  wherein said the coating of said coated granules comprises ethylcellulose. 
     
     
         18 . The method of  claim 6  wherein said coated granules are from about 840 microns to about 1340 microns in diameter. 
     
     
         19 . The method of  claim 12  wherein said coated granules are from about 840 microns to about 1340 microns in diameter. 
     
     
         20 . The method 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 method 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 . The method of  claim 6  wherein said administration is once daily. 
     
     
         23 . A method of manufacture of a dosage form comprising
 lithium carbonate   pylyvinylpyrrolidone   ethylcellulose and   talc;   said method 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.