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Details for Patent: 8,409,561

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Details for Patent: 8,409,561

Title:Methods and compositions for treatment of ion imbalances
Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising sodium-binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or sodium overload.
Inventor(s): Charmot; Dominique (Campbell, CA), Chang; Han-Ting (Livermore, CA), Liu; Mingjun (Campbell, CA), Liu; Futian (Sunnyvale, CA), Klaerner; Gerrit (Los Gatos, CA)
Assignee: Relypsa, Inc. (Redwood City, CA)
Filing Date:Aug 16, 2010
Application Number:12/857,264
Claims:1. A method of removing sodium from an animal subject comprising administering to an animal subject in need thereof an effective amount of a core-shell composition comprising a cation exchange core and a semi-permeable shell wherein the semi-permeable shell comprises a polymer containing at least one of a poly-11 trimethylammonioundecylmethacrylate polymer, or a 11-dimethyl-aminodecylmethacrylate/laurylmethacrylate copolymer, wherein said semi-permeable shell has a high permeability to sodium in the duodenum where the shell is in a hydrated state at neutral pH and has a reduced permeability to sodium in the cecum and colon where it is in a collapsed-impermeable state when the pH is 5 or 6, whereby as the core-shell composition passes from the duodenum to the cecum and colon its permeability to sodium decreases.

2. The method of claim 1 wherein said animal subject is suffering from hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or sodium overload.

3. The method of claim 1 wherein extra cellular water is removed from said animal subject.

4. The method of claim 1 wherein a beneficial effect is observed on fluid management, blood pressure control, and/or interdialytic weight gain.

5. The method of claim 1 wherein said animal subject is suffering from a disease characterized by a presence of abnormal quantities of sodium and/or water in the body of said animal subject.

6. The method of claim 1 wherein said animal subject is resistant to diuretic treatment and is suffering from hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or a combination thereof.

7. The method of claim 1 wherein treatment of said animal subject reduces formation of edema after a cardiac event.

8. The method of claim 1 wherein said animal subject is suffering from volume/salt sensitive diastolic heart failure.

9. The method of claim 1 wherein said composition is co-administered with a diuretic, an angiotensin converting enzyme (ACE) inhibitor, an .alpha.-blocker, a .beta.-blocker, an angiotensin II receptor blocker, or a combination thereof.

10. The method of claim 1 wherein said composition is co-administered with a laxative.

11. The method of claim 1, said cation exchange core being capable of binding sodium in an upper gastro-intestinal tract and the semi-permeable shell being characterized by decreased permeability to the bound sodium in a lower gastro-intestinal tract relative to the permeability exhibited by the core-shell composition to said bound sodium in the upper gastrointestinal tract.

12. The method of claim 11 wherein said composition is co-administered with a diuretic, an angiotensin converting enzyme (ACE) inhibitor, an .alpha.-blocker, a .beta.-blocker, an angiotensin II receptor blocker, or a combination thereof.

13. The method of claim 1 wherein said cation exchange core comprises a structural unit selected from the group consisting of ##STR00014##

14. The method of claim 13, said cation exchange core being capable of binding sodium in an upper gastro-intestinal tract and the semi-permeable shell being characterized by decreased permeability to the bound sodium in a lower gastro-intestinal tract relative to the permeability exhibited to said bound sodium in the upper gastrointestinal tract.

15. The method of claim 1 wherein the semi-permeable shell comprises the poly-11 trimethylammonioundecylmethacrylate polymer.

16. The method of claim 1 wherein the semi-permeable shell comprises the 11-dimethyl-aminodecylmethacrylate/laurylmethacrylate copolymer.
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