Direct compression polymer tablet core

Abstract

The present invention provides a tablet core which comprises at least about 95% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 95% by weight of an aliphatic amine polymer resin The method comprises the step of compressing the aliphatic amine polymer to form the tablet core. The tablet core can further include one or more excipients. In this embodiment, the method of producing the tablet core comprises the steps of: (1) hydrating the aliphatic amine polymer to the desired moisture level; (2) blending the aliphatic amine polymer with the excipients in amounts such that the polymer comprises at least about 95% by weight of the resulting blend; and (3) compressing the blend to form the tablet core. The present invention further relates to a coated tablet comprising an aliphatic amine polymer core wherein the coating is a water based coating.

1 - 4 . (canceled)  
   
   
       5 . A method of removing phosphate from a patient in need thereof comprising administering to said patient a tablet comprising a core and a coating thereof, wherein at least about 95% by weight of the core is an aliphatic amine polymer selected from the group consisting of unsubstituted and N-substituted poly(allylamine), poly(diallylamine), and poly(vinylamine).  
   
   
       6 . The method of  claim 5  wherein the N-substituents are selected from the group consisting of substituted and unsubstituted C 1 -C 24 -alkyl groups.  
   
   
       7 . The method of  claim 6  wherein the alkyl substituents are trialkylammonioalkyl groups.  
   
   
       8 . The method of  claim 5  wherein the aliphatic amine polymer is cross-linked.  
   
   
       9 . The method of  claim 5  wherein said core further comprises one or more excipients.  
   
   
       10 . A method of removing phosphate from a patient in need thereof comprising administering to said patient a tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a linear or cross-linked poly(allylamine) or a pharmaceutically acceptable salt thereof.  
   
   
       11 . The method of  claim 10  wherein the poly(allylamine) is hydrated.  
   
   
       12 . The method of  claim 11  wherein the poly(allylamine) comprises from about 3% to about 10% water.  
   
   
       13 . The method of  claim 12  wherein the poly(allylamine) comprises from about 5% to about 8% water.  
   
   
       14 . The method of  claim 13  wherein the polyallylamine is from about 1% to about 10% cross-linked.  
   
   
       15 . The method of  claim 5  wherein the coating is a water-based coating.  
   
   
       16 . The method of  claim 10  wherein the coating is a water-based coating.  
   
   
       17 . The method of  claim 16  wherein said water-based coating comprises hydroxypropylmethylcellulose and a plasticizer.  
   
   
       18 . The method of  claim 17  wherein said water-based coating comprises hydroxypropylmethylcellulose low viscosity, hydroxypropylmethylcellulose high viscosity, and diacetylated monoglyceride.  
   
   
       19 . A method of removing phosphate from a patient in need thereof comprising administering to said patient a tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a hydrated cross-linked poly(allylamine hydrochloride).  
   
   
       20 . The method of  claim 19  wherein said coating comprises diacetylated monoglyceride.  
   
   
       21 . The method of  claim 19  wherein said tablet has a hardness of at least about 150N.  
   
   
       22 . A method of removing phosphate from a patient in need thereof comprising administering to said patient a tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a linear or cross-linked poly(allylamine) or a pharmaceutically acceptable salt thereof, wherein the moisture content of the poly(allylamine) is from about 5% to about 9% by weight, wherein the hardness of the tablet is at least about 150 N and wherein the friability of the tablet is no more than 0.8%.  
   
   
       23 . A method of removing phosphate from a patient in need thereof comprising administering to said patient a tablet comprising a core and a coating therefor, wherein the core comprises 98% by weight sevelamer hydrochloride with a moisture content of from about 5% to about 9% by weight, 1% by weight colloidal silicon dioxide and 1% by weight stearic acid, and wherein the coating is a mixture comprising 38.5% w/w low viscosity hydroxypropylmethylcellulose, 38.5% high viscosity hydroxypropylmethylcellulose and 23% w/w diacetylated monoglyceride.  
   
   
       24 . The method of  claim 23  wherein said sevelamer hydrochloride has a moisture content of about 7% by weight.