Phosphate-binding chitosan and uses thereof
View Patent ↗The present invention provides compositions and methods for removing phosphate from a subject using chitosan. The present invention also provides compositions and methods for treating hyperphosphatemia based on phosphate-binding chitosan.
1. A method for treating hyperphosphatemia, the method comprising administering to a subject in need of treatment a composition comprising a therapeutically effective amount of chitosan,
wherein the chitosan has a degree of de-acetylation greater than about 95% and is characterized with an ability to binds at least about 60 mg phosphate per gram of chitosan in an in vitro phosphate-binding assay, and
wherein the therapeutically effective amount of chitosan ranges from 0.5 to about 25 grams per day.
2. The method of claim 1 , wherein said subject is in need of treatment for chronic kidney disease and/or end-stage renal disease.
3. The method of claim 1 , wherein said subject is in need of treatment for one or more disorders of phosphate metabolism and/or impaired phosphate transport function.
4. The method of claim 1 , wherein the chitosan is administered from about 0.1 to about 10 grams per dose.
5. The method of claim 1 , wherein the therapeutically effective amount is about 5 grams per day.
6. The method of claim 1 , wherein the chitosan is characterized with the ability to binds at least about 90 mg phosphate per gram of chitosan in the in vitro phosphate-binding assay.
7. The method of claim 1 , wherein the chitosan is characterized with the ability to binds at least about 120 mg phosphate per gram of chitosan in the in vitro phosphate-binding assay.
8. The method of claim 1 , wherein the chitosan is characterized with the ability to binds at least about 150 mg phosphate per gram of chitosan in the in vitro phosphate-binding assay.
9. The method of claim 1 , wherein the chitosan is characterized with the ability to binds at least about 180 mg phosphate per gram of chitosan in the in vitro phosphate-binding assay.
10. The method of claim 1 , wherein the chitosan is present in a form of a plurality of particles.
11. The method of claim 10 , wherein the plurality of particles have a mean volume particle size less than about 100 cubic microns.
12. The method of claim 10 , wherein the plurality of particles have a median volume particle size less than about 100 cubic microns.
13. The method of claim 10 , wherein the plurality of particles comprise one or more particles having a roundness greater than about 10.
14. The method of claim 13 , wherein at least about 0.3% of the plurality of particles have a roundness greater than 10.
15. The method of claim 1 , wherein the composition is administered orally.
16. The method of claim 1 , wherein the composition is a nutritional supplement.
17. The method of claim 16 , wherein the composition is administered three times daily with meals.
18. The method of claim 1 , wherein the composition further comprises a carrier.
19. The method of claim 18 , wherein the carrier is selected from the group consisting of a starch, a gum, an alginate, a silicate, dextrose, gelatin, lactose, mannitol, sorbitol, sucrose, tragacanth, cellulose, methyl cellulose, microcrystalline cellulose, a methylhydroxybenzoate, a propylhydroxybenzoate, polyvinylpyrrolidone and talc.
20. The method of claim 1 , wherein the composition is in a form of a cachet, a hard gelatin capsule, a soft gelatin capsule, an elixir, a lozenge, a pill, a powder, a sachet, a sterile packaged powder, a suspension, a syrup, or a tablet.
21. The method of claim 1 , wherein the therapeutically effective amount is about 10 grams per day.
22. The method of claim 1 , wherein the in vitro phosphate-binding assay uses monobasic potassium phosphate.