Details for Patent: 8,377,428
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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. |