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Details for Patent: 8,377,428

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Details for Patent: 8,377,428

Title:Low salt forms of polyallylamine
Abstract: Disclosed is a pharmaceutical composition comprising a stable polyallylamine hydrochloride polymer in which between about 4% to about 12% by weight of the polymer is a chloride anion and a pharmaceutically acceptable carrier or diluent.
Inventor(s): Petersen; John S. (Acton, MA), Burke; Steven K. (Sudbury, MA), Holmes-Farley; Stephen Randall (Arlington, MA)
Assignee: Genzyme Corporation (Cambridge, MA)
Filing Date:Apr 21, 2009
Application Number:12/427,127
Claims:1. A method of treating hyperphosphatemia in a patient in need thereof comprising administering to said patient a pharmaceutical composition comprising a pharmaceutically acceptable carrier or diluent and a stable polyallylamine hydrochloride polymer wherein between about 4% to about 12% by weight of the polymer is chloride anion and between about 9.0% to about 27.0% of the amine groups in the polyallylamine polymer are protonated.

2. The method of claim 1, wherein between about 5% to about 9% by weight of the polymer is chloride anion.

3. The method of claim 2, wherein the polymer is a homopolymer.

4. The method of claim 3, wherein the polyallylamine hydrochloride polymer comprises a repeat unit represented by Structural Formula (I): ##STR00003##

5. The method of claim 4, wherein the polymer is crosslinked.

6. The method of claim 5, wherein the polymer is crosslinked with 2-hydroxypropyl crosslinking groups.

7. The method of claim 1, wherein said pharmaceutical composition is administered in a dosage of between about 0.5 grams/day to about 10 grams/day.

8. The method of claim 7, wherein said pharmaceutical composition is administered in a dosage of between about 0.5 grams/day to about 10 grams/day.

9. A method of treating hyperphosphatemia in a patient in need thereof comprising administering to said patient a pharmaceutical composition comprising a pharmaceutically acceptable carrier or diluent and a stable polyallylamine homopolymer comprising repeat units represented by Structural Formula (I): ##STR00004## wherein the homopolymer is crosslinked with 2-hydroxypropyl groups, between about 9% and about 30% of the amine groups in the homopolymer are bonded to one of the 2-hydroxypropyl crosslinking groups, and between about 5% and about 9% by weight of the homopolymer is chloride anion and between about 9.0% to about 27.0% of the amine groups in the polyallylamine polymer are protonated.

10. The method of claim 9, wherein said pharmaceutical composition is administered in a dosage of between about 0.5 grams/day to about 10 grams/day.
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