Claims for Patent: 7,101,960

Summary for Patent: 7,101,960

Title:	Process for removing bile salts from a patient and alkylated compositions therefor
Abstract:	The invention relates to a method for reducing serum cholesterol in a patient in need thereof and alkylated and crosslinked poly(allylamine) polymers useful in the method. The alkylated and crosslinked poly(allylamine) polymers are crosslinked with epichlorohydrin and comprise at least some n-decyl substituted nitrogen atoms and at least some hexyltrimethyl ammonium substituted nitrogen atoms.
Inventor(s):	Mandeville, III; W. Harry (Lynnfield, MA), Holmes-Farley; Stephen Randall (Arlington, MA)
Assignee:	Genzyme Corporation (Cambridge, MA)
Application Number:	10/886,016
Patent Claims:	1. An alkylated and crossliniced poly(allylamine)polymer salt, comprising: (a) at least some n-decyl substituted nitrogen attoms; and (b) at least some hexyltrimethylammonium substitutcd nitrogen atoms, wherein the hexyltrimethylammonium has the structural formula --CH.sub.2(CH.sub.2).sub.5N.sup.-(CH.sub.3).sub.3 and wherein the alkylated and crosslinked poly(allylamine)polymer salt is crosslinked with epichlorohydrin. 2. The alkylated and crosslinked poly(allylamine)polymer salt of claim 1, having halide counterions. 3. The alkylated and crosslinked poly(allylamine)polymer salt of claim 2, having countetons selected from the group consisting of Cl.sup.-; Br.sup.-, and mixtures. thereof. 4. The alkylated and crosslinked poly(allylamine)polymer salt of claim 3, wherein the epichlorohydrin crosslinks between about 0.5 and 20% of the amine groups of the alkylated and crosslinked poly(allylamine)polymer salt. 5. The alkylated and crosslinked poly(allylamine)polymer salt of claim 4, having halide counterions. 6. The alkylated and crosslinked poly(allylamine)polymer salt of claim 5, having counterions selected from the group consisting of Cl.sup.-, Br.sup.-, and mixtures thereof. 7. A pharmaceutical composition comprising: (a) a pharmaceutically acceptable carrier, and (b) an alkylated and crosslinked poly(allylamine)polymer salt including: (i) at least some n-decyl substituted nitrogen atoms; and (ii) at least some hexyltrimethylammonium substituted nitrogen atoms, wherein the hexyltrimethylammonium has the structural formula --CH.sub.2(CH.sub.2).sub.5N.sup.-(CH.sub.3).sub.3 and wherein the alkylated and crosslinked poly(allylamine)polymer salt is crosslinked with epichlorohydrin. 8. The pharmaceutical composition of claim 7, wherein the alkylated and crosslinked poly(allylamine)polymer salt has halide counterions. 9. The pharmaceutical composition of claim 8, wherein the alkylated and crosslinked poly(allylamine)polymer salt has counterions selected from the group consisting of Cl.sup.-, Br.sup.-, and mixtures thereof. 10. The pharmaceutical composition of claim 7, wherein the epichlorohydrin crosslinks between about 0.5 and 20% at the amine groups of the alkylated and crosslinked poly(allylamine)polymer salt. 11. The pharmaceutical composition of claim 10, wherein the alkylated and crosslinKed poly(allylamine)polymer salt has halide counterions. 12. The pharmaceutical composition of claim 11, wherein the alkylated and crosslinked poly(allylamine)polymer salt has counterions selected from the group consisting of Cl.sup.-, Br.sup.-, and mixtures thereof. 13. A method of reducing the serum cholesterol of a patient, comprising orally administering to said patient a therapeutically effective amount of an alkylated and crosslinked poly(allylamine)polymer salt, comprising; (a) at least some n-decyl substituted nitrogen atoms; and (b) at least some hexyltrimethylammonium substituted nitrogen atoms, wherein the hexyltrimethylammonium has the structural formula --CH.sub.2(CH.sub.2).sub.5N.sup.-(CH.sub.3).sub.3 and wherein the alkylated and crosslinked poly(allylamine)polymer salt is crosslinked with epichlorohydrin. 14. The method of claim 13, wherein the alkylated and crosslinked poly(allylamine)polymer has halide counterions. 15. The method of claim 14, wherein the alkylated and crosslinked poly(allylamine)polymer has counterions selected from the group consisting of Cl.sup.-; Br.sup.-, and mixtures thereof. 16. The method of claim 13, wherein the epichlorohydrin crosslinks between about 0.5 and 2% of the amine groups of the alkylated and crosslinked poly(allylamine)polymer salt. 17. The method of claim 6, wherein the alkylated and crosslinked poly(allylamine)polymer has halide counterions. 18. The method of claim 17, wherein the alkylated and crosslinked poly(allylamine)polymer has counterions selected from the group consisting of Cl.sup.-, Br.sup.-, and mixtures thereof.