Methods and compositions for selectively removing potassium ion from the gastrointestinal tract of a mammal
The present invention provides methods and compositions for the treatment of ion imbalances using core-shell composites and compositions comprising such core-shell composites. In particular, the invention provides core-shell particles and compositions comprising potassium binding polymers, and core-shell particles and compositions comprising sodium binding polymers, and in each case, pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are also disclosed. The compositions and methods of the invention offer improved approaches for treatment of hyperkalemia and other indications related to potassium ion homeostasis, and for treatment of hypertension and other indicates related to sodium ion homeostasis.
1. A method for removing potassium from the gastrointestinal tract of a patient in need thereof comprising administering a potassium-binding particle comprising a core component and an optional shell component to the patient, the core component comprising an inorganic material, the particle having an average in vitro binding capacity of at least about 2.5 mmol per gram for binding potassium, and the patient being administered a drug that causes potassium retention selected from a potassium-sparing diuretic, an angiotensin-converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB), a non-steroidal anti-inflammatory drug, heparin, or trimethoprim.
2. The method of claim 1 wherein the potassium-binding particle is administered to the patient at a dose from about 0.5 grams per day to about 20 grams per day.
3. The method of claim 2 wherein the dose is from about 5 grams per day to about 20 grams per day.
4. The method of claim 2 wherein the dose is from about 5 grams per day to about 15 grams per day.
5. The method of claim 2 wherein the dose is from about 10 grams per day to about 20 grams per day.
6. The method of claim 2 wherein the dose is from about 10 grams per day to about 15 grams per day.
7. The method of claim 1 wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.0 mmol per gram.
8. The method of claim 1 wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.5 mmol per gram.
9. The method of claim 1 wherein the potassium-binding particle retains at least 5% of the bound potassium.
10. The method of claim 1 wherein the potassium-binding particle retains at least 25% of the bound potassium.
11. A method of treating hyperkalemia in a patient in need thereof comprising administering a potassium-binding particle comprising a core component and an optional shell component to the patient, the core component comprising an inorganic material, the particle having an average in vitro binding capacity of at least about 2.5 mmol per gram for binding potassium, and the patient being administered a drug that causes potassium retention selected from a potassium-sparing diuretic, an angiotensin-converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB), a non-steroidal anti-inflammatory drug, heparin, or trimethoprim.
12. The method of claim 11 wherein the potassium-binding particle is administered to the patient at a dose i& from about 0.5 grams per day to about 20 grams per day.
13. The method of claim 12 wherein the dose is from about 5 grams per day to about 20 grams per day.
14. The method of claim 12 wherein the dose is from about 5 grams per day to about 15 grams per day.
15. The method of claim 12 wherein the dose is from about 10 grams per day to about 20 grams per day.
16. The method of claim 12 wherein the dose is from about 10 grams per day to about 15 grams per day.
17. The method of claim 11 wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.0 mmol per gram.
18. The method of claim 11 wherein the potassium-binding particle has an average in vitro binding capacity of at least about 3.5 mmol per gram.
19. The method of claim 11 wherein the potassium-binding particle retains at least 5% of the bound potassium.
20. The method of claim 11 wherein the potassium-binding particle retains at least 25% of the bound potassium.
21. The method of claim 1 , wherein the inorganic material is a microporous or mesoporous material.
22. The method of claim 11 , wherein the inorganic material is a microporous or mesoporous material.