Crosslinked cation exchange polymers, compositions and use in treating hyperkalemia

A method for removing potassium from the gastrointestinal tract of an animal subject comprising administering once per day to an animal subject in need thereof a crosslinked cation exchange polymer or a pharmaceutical composition comprising a crosslinked cation exchange polymer, wherein a daily amount of the polymer has a potassium binding capacity of at least 75% of the same daily amount of the same polymer administered three times per day,

• wherein (i) the polymer comprises structural units corresponding to Formulae 1 and 2, Formulae 1 and 3, or Formulae 1, 2, and 3, wherein Formula 1, Formula 2, and Formula 3 are represented by the following structures:
• wherein
• R1 and R2 are each independently hydrogen, alkyl, cycloalkyl, or aryl;
• A1 is carboxylic, phosphonic, or phosphoric;
• X1 is arylene;
• and
• X2 is alkylene, an ether moiety, or an amide moiety;
• or
• (ii) the polymer is a reaction product of a polymerization mixture comprising monomers of either (i) Formulae 11 and 22, (ii) Formulae 11 and 33, or (iii) Formulae 11, 22, and 33, wherein Formula 11, Formula 22, and Formula 33 are represented by the following structures:
• wherein
• R1 and R2 are each independently hydrogen, alkyl, cycloalkyl, or aryl;
• A11 is an optionally protected carboxylic, phosphonic, or phosphoric;
• X1 is arylene;
• and
• X2 is alkylene, an ether moiety, or an amide moiety.

A method for removing potassium from the gastrointestinal tract of an animal subject comprising administering once per day to an animal subject in need thereof an effective amount of a crosslinked cation exchange polymer or a the pharmaceutical composition comprising a crosslinked cation exchange polymer, wherein less than 25% of subjects taking the polymer or the composition once per day experience mild or moderate gastrointestinal adverse events, the polymer comprising structural units corresponding to Formulae 1 and 2, Formulae 1 and 3, or Formulae 1, 2, and 3, wherein Formula 1, Formula 2, and Formula 3 are represented by the following structures:

• wherein
• R1 and R2 are each independently hydrogen, alkyl, cycloalkyl, or aryl;
• A1 is carboxylic, phosphonic, or phosphoric;
• X1 is arylene;
• and
• X2 is alkylene, an ether moiety, or an amide moiety.

A method for removing potassium from the gastrointestinal tract of an animal subject comprising administering once per day to an animal subject in need thereof an effective amount of a crosslinked cation exchange polymer or a the pharmaceutical composition comprising a crosslinked cation exchange polymer wherein less than 25% of subjects taking the polymer or composition once per day experience mild or moderate gastrointestinal adverse events, the polymer being a reaction product of a polymerization mixture comprising monomers of either (i) Formulae 11 and 22, (ii) Formulae 11 and 33, or (iii) Formulae 11, 22, and 33, wherein Formula 11, Formula 22, and Formula 33 are represented by the following structures:

• wherein
• R1 and R2 are each independently hydrogen, alkyl, cycloalkyl, or aryl;
• A11 is an optionally protected carboxylic, phosphonic, or phosphoric;
• X1 is arylene;
• and
• X2 is alkylene, an ether moiety, or an amide moiety.