Rapid dissolution formulation of a calcium receptor-active compound

Abstract

The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.

1 - 118 . (canceled) 
     
     
         119 . A pharmaceutical composition comprising:
 (a) from about 10% to about 40% by weight of cinacalcet HCI in an amount of from about 20 mg to about 100 mg;   (b) from about 45% to about 85% by weight of a diluent,   (c) from about 1% to about 5% by weight of at least one binder, and   (d) from about 1% to 10% by weight of at least one disintegrant,   wherein the percentage by weight is relative to the total weight of the composition, wherein the composition is obtained from a wet granulation process, and wherein the composition is for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.   
     
     
         120 . The composition according to  claim 119 , further comprising at least one excipient selected from the group consisting of lubricants and clear and color coating materials. 
     
     
         122 . The composition according to  claim 119 , further comprising from about 0.05% to about 5% of at least one additive selected from the group consisting of glidants, lubricants and adherents, wherein the percentage by weight is relative to the total weight of the composition. 
     
     
         123 . The composition according to  claim 119 , wherein the at least one diluent is selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof. 
     
     
         124 . The composition according to  claim 123 , wherein the diluent is microcrystalline cellulose or starch. 
     
     
         125 . The composition according to  claim 119 , wherein the at least one binder is selected from the group consisting of povidone, hydroxypropyl methylcellulose, dihydroxy propyl cellulose, sodium carboxymethylcellulose, and mixtures thereof. 
     
     
         126 . The composition according to  claim 125  wherein the at least one binder is povidone. 
     
     
         127 . The composition according to  claim 119 , wherein the at least one disintegrant is selected from the group consisting of crospovidine, sodium starch glycolate, croscarmellose sodium, and mixtures thereof. 
     
     
         128 . The composition according to  claim 127 , wherein the at least one disintegrant is crospovidone. 
     
     
         129 . A pharmaceutical composition comprising:
 (a) from about 10% to about 40% by weight of cinacalcet HCI in an amount of from about 20 mg to about 100 mg;   (b) from about 45% to about 85% by weight of a diluent selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof,   (c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and   (d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovidine, sodium starch glycolate, croscarmellose sodium, and mixtures thereof,   wherein the percentage by weight is relative to the total weight of the composition, wherein the composition is obtained from a wet granulation process, and wherein the composition is for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.   
     
     
         130 . The composition according to  claim 129 , further comprising at least one excipient selected from the group consisting of lubricants and clear and color coating materials. 
     
     
         131 . The composition according to  claim 129 , further comprising from about 1% to about 6% by weight of at least one coating material selected from the group consisting of clear and color coating materials wherein the percentage by weight is relative to the total weight of the composition. 
     
     
         132 . The composition according to  claim 129 , further comprising from about 0.05% to about 5% of at least one additive selected from the group consisting of glidants, lubricants and adherents, wherein the percentage by weight is relative to the total weight of the composition. 
     
     
         133 . The composition according to  claim 129 , wherein the at least one diluent is selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof. 
     
     
         134 . The composition according to  claim 133 , wherein the diluent is microcrystalline cellulose or starch. 
     
     
         135 . The composition according to  claim 129 , wherein the at least one binder is selected from the group consisting of povidone, hydroxypropyl methylcellulose, dihydroxy propyl cellulose, sodium carboxymethylcellulose, and mixtures thereof. 
     
     
         136 . The composition according to  claim 135  wherein the at least one binder is povidone. 
     
     
         137 . The composition according to  claim 129 , wherein the at least one disintegrant is selected from the group consisting of crospovidine, sodium starch glycolate, croscarmellose sodium, and mixtures thereof. 
     
     
         138 . The composition according to  claim 137 , wherein the at least one disintegrant is crospovidone.