Compositions and methods for treating hyperkalemia

Patent metadata

Field	Value
Publication number	US-9655921-B2
Application number	US-201514912682-A
Country	US
Kind code	B2
Filing date	Dec 22, 2015
Priority date	Dec 23, 2014
Publication date	May 23, 2017
Grant date	May 23, 2017

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.

First claim

What is claimed is:

1. A method for removing potassium from the gastrointestinal tract of a patient showing clinical signs of hyperkalemia or suspected of having hyperkalemia, comprising administering of a calcium salt of a potassium binding polymer, to the patient, wherein the crosslinked potassium binding polymer has the following structure:

wherein the ratio of “m” and “n” provides a polymer having 1.6% to 1.9% cross-linking.

2. The method of claim 1 , wherein the ratio of m to n is 68:1.

3. The method of claim 1 , wherein the potassium binding polymer is characterized by a swelling ratio in water of between about 3 grams of water per gram of polymer to about 8 grams of water per gram of polymer.

4. The method of claim 1 , wherein the potassium binding polymer is characterized by a swelling ratio in water of between about 3 grams of water per gram of polymer to about 4.5grams of water per gram of polymer.

5. The method of claim 1 , wherein the potassium binding polymer is characterized by a swelling ratio in water of about 3.3 grams of water per gram of polymer.

6. The method of claim 1 , wherein the potassium binding polymer is characterized by a swelling ratio in water of about 4.3 grams of water per gram of polymer.

7. The method of claim 1 , wherein the potassium binding polymer further comprises substantially spherical particles having a median diameter from about 5 μm to about 130 μm.

8. The method of claim 7 , wherein the particles have an average particle size Dv(0.9) between about 80 μm to about 130 μm.

9. The method of claim 7 , wherein the particles have an average particle size Dv(0.9) between about 90μm to about 120 μm.

10. The method of claim 7 , wherein the particles have an average particle size Dv(0.9) between about 40 μm to about 70 μm.

11. The method of claim 7 , wherein the particles have an average particle size Dv(0.9) between about 50μm to about 60 μm.

12. The method of claim 7 , wherein the particles have an average particle size Dv(0.5) between about 60 μm to about 90 μm.

13. The method of claim 7 , wherein the particles have an average particle size Dv(0.5) between about 70 μm to about 80 μm.

14. The method of claim 7 , wherein the particles have an average particle size Dv(0.5) between about 20 μm to about 50 μm.

15. The method of claim 14 , wherein the particles have an average particle size Dv(0.5) between about 30 μm to about 40 μm.

16. The method of claim 7 , wherein the particles have an average particle size Dv(0.1) between about 20 μm to about 70 μm.

17. The method of claim 7 , wherein the particles have an average particle size Dv(0.1) between about 30 μm to about 60 μm.

18. The method of claim 7 , wherein the particles have an average particle size Dv(0.1) between about 5 μm to about 30 μm.

19. The method of claim 7 , wherein the particles have an average particle size Dv(0.1) between about 6 μm to about 23 μm.

20. The method of claim 7 , wherein ratio of Dv(0.9):Dv(0.5) is about two or less and the ratio of Dv(0.5):Dv(0.1) is about five or less.

21. The method of claim 7 , wherein the ratio of Dv(0.9):Dv(0.5) and the ratio of Dv(0.5):Dv(0.1) are each independently about two or less.

22. The method of claim 1 ; wherein the potassium binding polymer has a potassium exchange capacity from about 1 mEq to about 4 mEq per gram of potassium binding polymer.

23. The method of claim 1 , wherein the potassium binding polymer is characterized by a crosslinking of about 1.8%, wherein the term about means ±5% of the specified value.

24. The method of claim 1 , wherein the potassium binding polymer is characterized by a crosslinking of 1.8%.

Assignees

• Ardelyx Inc

Inventors

• Charmot Dominique
• Davidson James P
• Lin Fangling
• Jacobs Jeffrey W
• Blinova Natalia
• Labonte Eric
• Langsetmo Ingrid
• Blanks Robert C

Classifications

• A61P7/08

  Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04) · CPC title

• A61P3/12

  for electrolyte homeostasis · CPC title

• A61K9/1623

  Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules · CPC title

• A61K31/745

  Polymers of hydrocarbons · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title