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Details for Patent: 8,192,758

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Details for Patent: 8,192,758

Title:Ion binding compositions
Abstract: The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides core-shell compositions and pharmaceutical compositions thereof. Methods of use of the core-shell compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of phosphate imbalance disorders, hypertension, chronic heart failure, end stage renal disease, liver cirrhosis, chronic renal insufficiency, fluid overload, or sodium overload.
Inventor(s): Charmot; Dominique (Campbell, CA), Fordtran; John (Dallas, TX), Chang; Han Ting (Livermore, CA), Connor; Eric (Los Gatos, CA), Liu; Mingjun (Santa Clara, CA), Klaerner; Gerrit (San Jose, CA)
Assignee: Relypsa, Inc. (Santa Clara, CA)
Filing Date:Mar 30, 2004
Application Number:10/814,749
Claims:1. A method of treating an animal subject suffering from a disease selected from the group consisting of renal insufficiency, renal failure, end stage renal disease (ESRD) and combinations thereof, comprising administering to an animal subject in need thereof an effective amount of the pharmaceutical composition of an oral or rectal pharmaceutical composition comprising core-shell particles and a pharmaceutically acceptable excipient, said core-shell particles comprising a core component and a shell component, the core component comprising a potassium-binding cation exchange polymer, the shell component comprising a crosslinked polymer having a thickness ranging from about 0.002 microns to about 50 microns, the shell component being essentially not disintegrated during residence and passage through the gastro-intestinal tract of an animal subject.

2. A method of treating an animal subject suffering from a disease selected from the group consisting of renal insufficiency, renal failure, end stage renal disease (ESRD) and combinations thereof, comprising administering to an animal subject in need thereof an effective amount of the pharmaceutical composition of an oral or rectal pharmaceutical composition comprising core-shell particles and a pharmaceutically acceptable excipient, said core-shell particles comprising a core component and a shell component, the core component comprising a potassium-binding cation exchange polymer, the shell component comprising a crosslinked polymer, the weight ratio of the shell component polymer to the core component polymer ranging from about 0.0001: 1 to about 0.5:1, the shell component being essentially not disintegrated during residence and passage through the gastro-intestinal tract of an animal subject.

3. The method of claim 1 wherein said core-shell particle is about 200 nm to about 2 mm in size.

4. The method of claim 1 wherein said shell component polymer has a thickness ranging from about 0.005 .mu.m to less than about 10 .mu.m.

5. The method of claim 1 wherein said shell component polymer has a thickness ranging from more than about 1 gm to less than about 10 .mu.m.

6. The method of claim 1 wherein the core component comprises a cation-exchange polymer comprising acidic functional groups.

7. The method of claim 5 wherein the core component comprises a cation-exchange polymer comprising functional groups selected from the group consisting of carboxylate, phosphonate, sulfate, sulfonate, sulfamate and combinations thereof

8. The method of claim 1 wherein the shell component comprises a crosslinked synthetic polymer.

9. The method of claim 1 wherein the shell component comprises a polymer produced by polymerization of an ethylenic monomer.

10. The method of claim 1 wherein the shell component comprises a polymer produced by polymerization of a vinylic monomer.

11. The method of claim 7 wherein the shell component comprises a polymer produced by polymerization of an acrylic or methacrylic monomer.

12. The method of claim 1 wherein the shell component comprises a hydrophobic polymer, and is essentially not disintegrated during residence and passage of the core-shell particles through the gastro-intestinal tract of a human subject, and wherein the core-shell particles bind potassium ion and retain bound potassium ion during residence and passage through the gastrointestinal tract of the human subject, such that potassium ion is removed from the gastrointestinal tract of the human subject by the core-shell particles to obtain a therapeutic and/or prophylactic benefit.

13. The method of claim 2 wherein the weight ratio of the shell component polymer to the core component polymer ranges from about 0.002:1 to about 0.1:1.

14. The method of claim 2 wherein the core component comprises a cation-exchange polymer comprising acidic functional groups.

15. The method of claim 2 wherein the core component comprises a cation-exchange polymer comprising functional groups selected from the group consisting of carboxylate, phosphonate, sulfate, sulfonate, sulfamate and combinations thereof

16. The method of claim 2 wherein the shell component comprises a crosslinked synthetic polymer.

17. The method of claim 2 wherein the shell component comprises a polymer produced by polymerization of an ethylenic monomer.

18. The method of claim 2 wherein the shell component comprises a polymer produced by polymerization of a vinylic monomer.

19. The method of claim 2 wherein the shell component comprises a polymer produced by polymerization of an acrylic or methacrylic monomer.

20. The method of claim 2 wherein the shell component comprises a hydrophobic polymer, and is essentially not disintegrated during residence and passage of the core-shell particles through the gastro-intestinal tract of a human subject, and wherein the core-shell particles bind potassium ion and retain bound potassium ion during residence and passage through the gastrointestinal tract of the human subject, such that potassium ion is removed from the gastrointestinal tract of the human subject by the core-shell particles to obtain a therapeutic and/or prophylactic benefit.

21. The method of claim 2 wherein the core component comprises a crosslinked cation-exchange polymer comprising acidic functional groups, and the shell component comprises a crosslinked synthetic polymer.

22. The method of claim 21 wherein the shell component comprises a polymer produced by polymerization of an acrylic or methacrylic monomer.
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