Pharmaceutical formulations of sevalamer, or salts thereof, and copovidone

A pharmaceutical composition useful for treating hyperphosphatemia in mammals, wherein the composition comprises:

• a tablet comprising a tablet core and a tablet coating applied to the exterior of the core, wherein:
• the core comprises from about 80 to about 95 percent by weight sevelamer, wherein the sevelamer is selected from the group consisting of sevelamer, sevelamer HCl, sevelamer carbonate, and combinations thereof, and wherein the core further comprises copovidone in an amount ranging from about 1 to about 20 weight percent of the total weight of the core, and wherein the core further comprises stearic acid in an amount ranging from about 0.01 weight percent to about 5 weight percent of the total weight of the tablet core, and wherein the core further comprises colloidal SiO2 ranging from about 0.01 weight percent to about 5 weight percent of the total weight of the tablet core;
• and
• the coating comprises at least one ingredient selected from the group consisting of titanium dioxide, hydroxypropyl cellulose, hydroxypropylmethyl cellulose having a viscosity of about 50 cP, hydroxypropylmethyl cellulose having a viscosity of about 3 cP, poly(ethylene-glycol), and mixtures thereof, wherein the coating comprises from about 1 to about 10 weight percent of the pharmaceutical composition.

A method of making a pharmaceutical composition comprising a tablet, wherein the method comprises the steps of:

• a) providing a tablet core mixture comprising from about 80 to about 95 percent by weight sevelamer, wherein the sevelamer is selected from the group consisting of sevelamer, sevelamer HCl, sevelamer carbonate, and combinations thereof, and wherein the core further comprises copovidone in an amount ranging from about 1 to about 20 weight percent of the total weight of the core, and wherein the core mixture further comprises stearic acid in an amount ranging from about 0.01 weight percent to about 5 weight percent of the total weight of the tablet core, and wherein the core mixture further comprises colloidal SiO2 ranging from about 0.01 weight percent to about 5 weight percent of the total weight of the tablet core;
• b) compressing the tablet core mixture with a force ranging from about 1 to about 20 kilonewtons;
• c) providing a tablet coating mixture comprising at least one ingredient selected from the group consisting of titanium dioxide, hydroxypropyl cellulose, hydroxypropylmethyl cellulose having a viscosity of about 50 cP, hydroxypropylmethyl cellulose having a viscosity of about 3 cP, poly(ethylene-glycol), and mixtures thereof, and
• d) coating the tablet core with the coating mixture;
• wherein the tablet has a hardness of ranging from about 30 SCU to about 60 SCU, and a disintegration time ranging from about 1 minute to 10 minutes in an aqueous solution at a pH of about 7.