Pharmaceutical formulation comprising lanthanum compounds

Abstract

This invention relates to a chewable lanthanum formulation comprising a pharmaceutically effective amount of a lanthanum compound; and at least one chewable pharmaceutically acceptable excipient. This invention also relates to a pharmaceutical formulation in a tablet or in a powder comprising a pharmaceutically effective amount of a lanthanum compound produced by a process which comprises the steps of (a) powder blending the lanthanum compound and at least one pharmaceutically acceptable excipient in a mixer to form a mixture; or (b) powder blending the lanthanum compound and excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and (c) compressing the resulting mixture into a tablet or filling up the resulting mixture in an appropriate container.

1 . A chewable lanthanum formulation in a tablet comprising a pharmaceutically effective amount of a lanthanum compound and at least one chewable pharmaceutically acceptable excipient. 
   
   
       2 . The chewable formulation of  claim 1  wherein said tablet contains more than about 200 mg of elemental lanthanum. 
   
   
       3 . The chewable formulation of  claim 1  wherein said tablet contains more than about 250 mg of elemental lanthanum. 
   
   
       4 . The chewable formulation of  claim 1  wherein said tablet contains about 250 mg of elemental lanthanum. 
   
   
       5 . The chewable formulation of  claim 1  wherein said tablet contains more than about 500 mg of elemental lanthanum. 
   
   
       6 . The chewable formulation of  claim 1  wherein said tablet contains about 500 mg of elemental lanthanum. 
   
   
       7 . The chewable formulation of  claim 1  wherein said tablet contains more than about 750 mg of elemental lanthanum. 
   
   
       8 . The chewable formulation of  claim 1  wherein said tablet contains about 750 mg of elemental lanthanum. 
   
   
       9 . The chewable formulation of  claim 1  wherein said tablet contains more than about 1000 mg of elemental lanthanum. 
   
   
       10 . The chewable formulation of  claim 1  wherein said tablet contains about 1000 mg of elemental lanthanum. 
   
   
       11 . The chewable formulation of  claim 1  wherein said tablet contains from about 200 mg of elemental lanthanum to about 1000 mg. 
   
   
       12 . The chewable formulation according to  claim 1  wherein said lanthanum compound is lanthanum carbonate. 
   
   
       13 . The chewable formulation according to  claim 1  wherein said lanthanum compound is lanthanum carbonate of the general formula:
   La 2 (CO 3 ) 3   .x H 2 O   
     where x has a value from 3 to 8. 
   
   
       14 . The chewable formulation of  claim 13  wherein x has a value from 3 to 7. 
   
   
       15 . The chewable formulation of  claim 13  wherein x has a value from 3 to 6. 
   
   
       16 . The chewable formulation of  claim 13  wherein x has a value from 3 to 5. 
   
   
       17 . The chewable formulation of  claim 13  wherein x has a value from 4 to 5. 
   
   
       18 . The chewable formulation of  claim 1  wherein the excipient is chosen from the group consisting of diluents and blending flow-lubricant agents. 
   
   
       19 . The chewable formulation of  claim 18  wherein which comprises at least one diluant selected from the group consisting of dextrates, corn syrup, oligosaccharide, isomaltooligosaccharide, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, polydextrose, dextrin, starch, fructose, xylitol, maltodextrin, maltitol, isomalt, lactose, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, confectioner's sugar, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose inositol, hydrolyzed cereal solids, amylose and glycine. 
   
   
       20 . The chewable formulation of  claim 18  wherein which comprises at least one diluant selected from the group consisting of dextrates, starch, lactose, mannitol, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, confectioner's sugar, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose, inositol, hydrolyzed cereal solids, amylose and glycine. 
   
   
       21 . The chewable formulation of  claim 18  which comprises at least one diluant selected from the group consisting of diluents can be chosen from dextrates, starch, lactose, mannitol, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose, inositol, and amylose. 
   
   
       22 . The chewable formulation of  claim 18  which comprises at least one diluant selected from the group consisting of dextrates, fructose, xylitol, erythritol, maltodextrin, dextrose, maltitol, isomalt and glucose. 
   
   
       23 . The chewable formulation of  claim 18  wherein the diluent is dextrates. 
   
   
       24 . The chewable formulation according to  claim 1  which comprises dextrates as a diluent in an amount from about 10% to about 90% by weight based on the total weight of all ingredients. 
   
   
       25 . The chewable formulation according to  claim 12  which comprises dextrates as a diluent in an amount from about 10% to about 90% by weight based on the total weight of all ingredients. 
   
   
       26 . The chewable formulation according to  claim 13  which comprises dextrates as a diluent in an amount from about 10% to about 90% by weight based on the total weight of all ingredients. 
   
   
       27 . The chewable formulation according to  claim 1  which comprises dextrates as a diluent in an amount from about 40% to about 80% by weight based on the total weight of all ingredients. 
   
   
       28 . The chewable formulation according to  claim 12  which comprises dextrates as a diluent in an amount from about 40% to about 86% by weight based on the total weight of all ingredients. 
   
   
       29 . The chewable formulation according to  claim 13  which comprises dextrates as a diluent in an amount from about 40% to about 80% by weight based on the total weight of all ingredients. 
   
   
       30 . The chewable formulation according to  claim 1  which comprises dextrates as a diluent in an amount from about 30% to about 60% by weight based on the total weight of all ingredients. 
   
   
       31 . The chewable formulation according to  claim 12  which comprises dextrates as a diluent in an amount from about 30% to about 60% by weight based on the total weight of all ingredients. 
   
   
       32 . The chewable formulation according to  claim 13  which comprises dextrates as a diluent in an amount from about 30% to about 60% by weight based on the total weight of all ingredients. 
   
   
       33 . The chewable formulation according to any one of  claims 1  to  11  which comprises dextrates as a diluent in an amount from about 40% to about 60% by weight based on the total weight of all ingredients. 
   
   
       34 . The chewable formulation according to  claim 12  which comprises dextrates as a diluent in an amount from about 40% to about 60% by weight based on the total weight of all ingredients. 
   
   
       35 . The chewable formulation according to  claim 13  which comprises dextrates as a diluent in an amount from about 40% to about 60% by weight based on the total weight of all ingredients. 
   
   
       36 . The chewable formulation of  claim 18  which comprises blending flow-agents lubricating agents selected from the group consisting of magnesium stearate, talc: polyethylene glycol, silica, colloidal anhydrous silica, hydrogenated vegetable oils, glyceryl behenate and glyceryl monostearate. 
   
   
       37 . A pharmaceutical formulation in a tablet or in a powder comprising a pharmaceutically effective amount of a lanthanum compound produced by a process which comprises the steps of
 a. powder blending the lanthanum compound and at least one pharmaceutically acceptable excipient in a mixer to form a mixture; or   b. powder blending the lanthanum compound and excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and   c. compressing the mixture into a tablet or filing up the resulting mixture in an appropriate container.   
   
   
       38 . A pharmaceutical formulation in a tablet or in a powder comprising a pharmaceutically effective amount of a lanthanum compound produced by a process which comprises the steps of compressing the lanthanum compound into a slug material or roller compacting into a strand material, and milling the prepared material into a free flowing material, then blending with excipients, the resulting combination is compressed into a tablet or filling up the resulting mixture in an appropriate container. 
   
   
       39 . A pharmaceutical formulation in a chewable tablet comprising a pharmaceutically effective amount of a lanthanum compound produced by a process which comprises the steps of:
 a. powder blending the lanthanum compound and at least one pharmaceutically acceptable excipient in a mixer to form a mixture; and   b. compressing the mixture into a tablet.   
   
   
       40 . A method for treating, hyperphosphataemia comprising administering a therapeutically effective amount of a lanthanum formulation according to  claim 1  to a patient in need of thereof. 
   
   
       41 . A method for treating hyperphosphataemia comprising administering a therapeutically effective amount of a lanthanum formulation according to  claim 12  to a patient in need of thereof. 
   
   
       42 . A method for treating hyperphosphataemia comprising administering a therapeutically effective amount of a lanthanum formulation according to  claim 13  to a patient in need of thereof. 
   
   
       43 . A process for preparing a tablet formulation of a lanthanum compound which comprises the steps of:
 a. powder blending the lanthanum compound and at least one pharmaceutically acceptable excipient in a mixer to form a mixture; and   b. compressing the mixture into a tablet.