Compositions and methods for treating hyperkalemia
Inventors
Charmot, Dominique • Davidson, James P. • Lin, Fangling • Jacobs, Jeffrey W. • Blinova, Natalia • Labonte, Eric • Langsetmo, Ingrid • Blanks, Robert C.
Assignees
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Publication Number
US-9867848-B2
Publication Date
2018-01-16
Expiration Date
Abstract
The present invention is directed to compositions and methods of removing potassium or treating hyperkalemia by administering pharmaceutical compositions of cation exchange polymers with low crosslinking for improved potassium excretion and for beneficial physical properties to increase patient compliance.
Core Innovation
The invention provides calcium salts of crosslinked potassium binding polymers having a defined cross-linking level of 1.0% to 1.9%. The polymer is described as a potassium exchange polymer with substantially spherical particles and specified particle properties, including particle size distribution relationships, swelling ratio in water, potassium exchange capacity, and a Mouth Feel score threshold.
The document further characterizes the calcium salt crosslinked potassium binding polymer by particle size distribution relationships defined by Dv(0.1), Dv(0.5), and Dv(0.9), and by being substantially endotoxin free. The described polymer may be provided as a pharmaceutical composition including a pharmaceutically acceptable carrier, diluent, or excipient.
The patent also identifies the calcium salt form as a crosslinked potassium binding polystyrene sulfonate divinylbenzene polymer with crosslinking of 1.0% to 1.9%. Therapeutic methods are described for removing potassium from the gastrointestinal tract of patients with or suspected of hyperkalemia, and comparative effects are described using fecal and urinary potassium excretion outcomes.
Claims Coverage
The partial content includes two independent claims. Across these claims, the core inventive focus is a calcium salt of a crosslinked potassium binding polymer with crosslinking defined as 1.0% to 1.9%, including one claim family that specifies a crosslinked potassium binding polystyrene sulfonate divinylbenzene polymer.
Calcium salt crosslinked potassium binding polymer with m:n-defined crosslinking
A calcium salt of a crosslinked potassium binding polymer defined by a structure wherein the ratio of “m” and “n” provides a polymer having 1.0% to 1.9% cross-linking.
Calcium salt of crosslinked potassium binding polystyrene sulfonate divinylbenzene polymer with specified crosslinking
A calcium salt of a crosslinked potassium binding polystyrene sulfonate divinylbenzene polymer characterized by a crosslinking of 1.0% to 1.9%.
The independent claims are directed to calcium salt forms of crosslinked potassium binding polymers where crosslinking is constrained to 1.0% to 1.9%. The claims also link this polymer to particle properties, swelling ratio, potassium exchange capacity, Mouth Feel score, and pharmaceutical composition form with pharmaceutically acceptable carriers or excipients.
Stated Advantages
Improved patient tolerance, supported by a Mouth Feel score greater than 3.5.
The polymer is substantially endotoxin free.
Controlled swelling ratio in water (3–8 g water/g polymer).
Specified potassium exchange capacity (1–4 mEq/g).
Removal of potassium from the gastrointestinal tract of patients with or suspected of hyperkalemia, supported by fecal and urinary potassium excretion effects.
Documented Applications
Treating hyperkalemia by administering the calcium salt of a crosslinked potassium binding polymer.
Removing potassium from the gastrointestinal tract of patients with or suspected of hyperkalemia.
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