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Details for Patent: 8,282,960

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Details for Patent: 8,282,960

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:10/813,872
Claims:1. An oral or rectal pharmaceutical composition comprising a pharmaceutically acceptable excipient, and core-shell particles, 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 synthetic polymer, the synthetic polymer being produced by free radical polymerization of an ethylenic monomer selected from the group consisting of acrylic, methacrylic, styrenic, dienic, vinylic and combinations thereof and being essentially not disintegrated during residence and passage through the gastro-intestinal tract of an animal subject.

2. A method of removing potassium ion from a gastrointestinal tract of an animal subject in need thereof and suffering from renal insufficiency or renal failure, the method comprising: administering to the animal subject suffering from renal insufficiency or renal failure a composition comprising core-shell particles, the 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 polymer being produced by free radical polymerization of an ethylenic monomer, binding potassium ion with the core-shell particles in the gastrointestinal tract of the animal subject, and retaining bound potassium ion with the core-shell particles during residence and passage of the core-shell particles through the gastro-intestinal tract of the animal subject suffering from renal insufficiency or renal failure, such that potassium ion is removed from the gastrointestinal tract of the animal subject by the core-shell particles to obtain a therapeutic and/or prophylactic benefit.

3. An oral pharmaceutical composition comprising a pharmaceutically acceptable excipient and core-shell particles, 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 produced by polymerization of an acrylic or methacrylic monomer wherein said shell component is about 0.005 microns to about 20 microns thick and said core-shell particle is about 200 nm to about 2 mm in size and the shell component being essentially not disintegrated during residence and passage through the gastro-intestinal tract of an animal subject.

4. The pharmaceutical composition of claim 1 wherein said core component is physically or chemically attached to said shell component.

5. The pharmaceutical composition or method of claim 1 or 2 wherein said shell component is about 1 nm to about 50 .mu.m thick.

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

7. The pharmaceutical composition or method of claim 1 or 2 wherein said shell component is about 0.005 microns to about 20 microns thick.

8. The pharmaceutical composition of claim 1 wherein said shell component is deposited with a coating process.

9. The pharmaceutical composition of claim 1 further comprising an enteric coating.

10. The pharmaceutical composition or method of claim 1 or 2 wherein the core component comprises a crosslinked cation-exchange polymer.

11. The pharmaceutical composition or method of claim 1 or 2 wherein the core component comprises a cation-exchange polymer comprising acidic functional groups.

12. The pharmaceutical composition or method of claim 1 or 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.

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

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

15. The method of claim 2 wherein the shell component comprises a polymer produced by polymerization of an ethylenic monomer selected from the group consisting of acrylic, methacrylic, styrenic, dienic, vinylic and combinations thereof.

16. The pharmaceutical composition or method of claim 1 or 2 wherein the shell component comprises a polymer produced by polymerization of a vinylic monomer.

17. The pharmaceutical composition or method of claim 1 or 2 wherein the shell component comprises a polymer produced by polymerization of an acrylic or methacrylic monomer.

18. The method of claim 2 wherein the shell component is essentially not disintegrated during residence and passage of the core-shell particles through the gastro-intestinal tract.

19. The pharmaceutical composition or method of claim 1 or 2 wherein the core-shell particles retain at least about 50% of the bound potassium ion with the core-shell particles during residence and passage of the core-shell particles through the gastrointestinal tract.

20. The pharmaceutical composition of claim 1 wherein said core-shell particles bind potassium ion in a gastrointestinal tract of an animal subject suffering from renal insufficiency or renal failure, and retain bound potassium ion during residence and passage of the core-shell particles through the gastrointestinal tract of the animal subject suffering from renal insufficiency or renal failure, such that potassium ion is removed from the gastrointestinal tract of the animal by the core-shell particles to obtain a therapeutic and/or prophylactic benefit.

21. The pharmaceutical composition or method of claim 2 or 3 wherein the animal subject is a human suffering from end stage renal disease (ESRD).

22. The pharmaceutical composition or method of claim 2 or 3 wherein the animal subject is a human dialysis patient.

23. The pharmaceutical composition or method of claim 2 or 3 wherein the animal subject is a human suffering from hyperkalemia.

24. The pharmaceutical composition or method of claim 1 or 2 wherein the shell component is hydrophobic.

25. The pharmaceutical composition or method of claim 1 or 2 wherein the core component comprises a crosslinked cation-exchange polymer comprising acidic functional groups, and the shell component comprises a crosslinked synthetic polymer.

26. The pharmaceutical composition or method of claim 25 wherein the shell component is hydrophobic.

27. The pharmaceutical composition or method of claim 25 wherein the shell component comprises a polymer produced by polymerization of a vinylic monomer.

28. The pharmaceutical composition or method of claim 25 wherein the shell component comprises a polymer produced by polymerization of an acrylic or methacrylic monomer.

29. The pharmaceutical composition or method of claim 2 or 20 wherein the core-shell particles retain at least about 75% of the bound potassium ion with the core-shell particles during residence and passage of the core-shell particles through the gastro-intestinal tract.

30. The pharmaceutical composition of claim 1 or 3 wherein the oral pharmaceutical composition is in the form of a powder, tablet, capsule, or emulsion.
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