CA2558029A1 - Ion binding polymers and uses thereof - Google Patents
Ion binding polymers and uses thereof Download PDFInfo
- Publication number
- CA2558029A1 CA2558029A1 CA002558029A CA2558029A CA2558029A1 CA 2558029 A1 CA2558029 A1 CA 2558029A1 CA 002558029 A CA002558029 A CA 002558029A CA 2558029 A CA2558029 A CA 2558029A CA 2558029 A1 CA2558029 A1 CA 2558029A1
- Authority
- CA
- Canada
- Prior art keywords
- polymer
- potassium
- shell
- binding
- binding polymer
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 229920000642 polymer Polymers 0.000 title claims abstract 73
- 238000000034 method Methods 0.000 claims abstract 55
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims abstract 48
- 239000011591 potassium Substances 0.000 claims abstract 48
- 229910052700 potassium Inorganic materials 0.000 claims abstract 48
- 239000000203 mixture Substances 0.000 claims abstract 19
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 11
- 208000002682 Hyperkalemia Diseases 0.000 claims abstract 5
- 229940079593 drug Drugs 0.000 claims abstract 3
- 239000003814 drug Substances 0.000 claims abstract 3
- 241001465754 Metazoa Species 0.000 claims 18
- MYRTYDVEIRVNKP-UHFFFAOYSA-N 1,2-Divinylbenzene Chemical compound C=CC1=CC=CC=C1C=C MYRTYDVEIRVNKP-UHFFFAOYSA-N 0.000 claims 14
- 150000002500 ions Chemical class 0.000 claims 10
- TYCFGHUTYSLISP-UHFFFAOYSA-N 2-fluoroprop-2-enoic acid Chemical compound OC(=O)C(F)=C TYCFGHUTYSLISP-UHFFFAOYSA-N 0.000 claims 6
- 229920002873 Polyethylenimine Polymers 0.000 claims 6
- 238000000576 coating method Methods 0.000 claims 5
- 239000011258 core-shell material Substances 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 4
- 229920001577 copolymer Polymers 0.000 claims 4
- ZYMKZMDQUPCXRP-UHFFFAOYSA-N fluoro prop-2-enoate Chemical compound FOC(=O)C=C ZYMKZMDQUPCXRP-UHFFFAOYSA-N 0.000 claims 4
- 230000035699 permeability Effects 0.000 claims 4
- 238000001556 precipitation Methods 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 229920003155 Eudragit® RL 100 Polymers 0.000 claims 3
- 229920003159 Eudragit® RS 100 Polymers 0.000 claims 3
- 150000001768 cations Chemical class 0.000 claims 3
- 239000011248 coating agent Substances 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 238000009472 formulation Methods 0.000 claims 3
- 239000012528 membrane Substances 0.000 claims 3
- 229920001467 poly(styrenesulfonates) Polymers 0.000 claims 3
- 239000011970 polystyrene sulfonate Substances 0.000 claims 3
- 229960002796 polystyrene sulfonate Drugs 0.000 claims 3
- JUVWKFKXIVLAHQ-UPHRSURJSA-N (z)-2,3-difluorobut-2-enedioic acid Chemical compound OC(=O)C(\F)=C(\F)C(O)=O JUVWKFKXIVLAHQ-UPHRSURJSA-N 0.000 claims 2
- 239000005541 ACE inhibitor Substances 0.000 claims 2
- VVJKKWFAADXIJK-UHFFFAOYSA-N Allylamine Chemical compound NCC=C VVJKKWFAADXIJK-UHFFFAOYSA-N 0.000 claims 2
- ZRALSGWEFCBTJO-UHFFFAOYSA-N Guanidine Chemical compound NC(N)=N ZRALSGWEFCBTJO-UHFFFAOYSA-N 0.000 claims 2
- 229940122767 Potassium sparing diuretic Drugs 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 claims 2
- 150000008064 anhydrides Chemical class 0.000 claims 2
- 239000002131 composite material Substances 0.000 claims 2
- CVSVTCORWBXHQV-UHFFFAOYSA-N creatine Chemical compound NC(=[NH2+])N(C)CC([O-])=O CVSVTCORWBXHQV-UHFFFAOYSA-N 0.000 claims 2
- 125000006575 electron-withdrawing group Chemical group 0.000 claims 2
- 239000002702 enteric coating Substances 0.000 claims 2
- 238000009505 enteric coating Methods 0.000 claims 2
- IQIJRJNHZYUQSD-UHFFFAOYSA-N ethenyl(phenyl)diazene Chemical compound C=CN=NC1=CC=CC=C1 IQIJRJNHZYUQSD-UHFFFAOYSA-N 0.000 claims 2
- 210000001035 gastrointestinal tract Anatomy 0.000 claims 2
- 150000004820 halides Chemical class 0.000 claims 2
- 239000003999 initiator Substances 0.000 claims 2
- 230000014759 maintenance of location Effects 0.000 claims 2
- 229910052757 nitrogen Inorganic materials 0.000 claims 2
- 239000003286 potassium sparing diuretic agent Substances 0.000 claims 2
- 229940097241 potassium-sparing diuretic Drugs 0.000 claims 2
- 150000003254 radicals Chemical class 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 claims 2
- 230000001960 triggered effect Effects 0.000 claims 2
- NLVXSWCKKBEXTG-UHFFFAOYSA-N vinylsulfonic acid Chemical compound OS(=O)(=O)C=C NLVXSWCKKBEXTG-UHFFFAOYSA-N 0.000 claims 2
- PHIQHXFUZVPYII-ZCFIWIBFSA-O (R)-carnitinium Chemical compound C[N+](C)(C)C[C@H](O)CC(O)=O PHIQHXFUZVPYII-ZCFIWIBFSA-O 0.000 claims 1
- SOBDFTUDYRPGJY-UHFFFAOYSA-N 1,3-bis(ethenylsulfonyl)propan-2-ol Chemical compound C=CS(=O)(=O)CC(O)CS(=O)(=O)C=C SOBDFTUDYRPGJY-UHFFFAOYSA-N 0.000 claims 1
- LGJCFVYMIJLQJO-UHFFFAOYSA-N 1-dodecylperoxydodecane Chemical group CCCCCCCCCCCCOOCCCCCCCCCCCC LGJCFVYMIJLQJO-UHFFFAOYSA-N 0.000 claims 1
- OZDGMOYKSFPLSE-UHFFFAOYSA-N 2-Methylaziridine Chemical compound CC1CN1 OZDGMOYKSFPLSE-UHFFFAOYSA-N 0.000 claims 1
- QWZOJDWOQYTACD-UHFFFAOYSA-N 2-ethenylsulfonyl-n-[2-[(2-ethenylsulfonylacetyl)amino]ethyl]acetamide Chemical compound C=CS(=O)(=O)CC(=O)NCCNC(=O)CS(=O)(=O)C=C QWZOJDWOQYTACD-UHFFFAOYSA-N 0.000 claims 1
- VXDHQYLFEYUMFY-UHFFFAOYSA-N 2-methylprop-2-en-1-amine Chemical compound CC(=C)CN VXDHQYLFEYUMFY-UHFFFAOYSA-N 0.000 claims 1
- KGIGUEBEKRSTEW-UHFFFAOYSA-N 2-vinylpyridine Chemical compound C=CC1=CC=CC=N1 KGIGUEBEKRSTEW-UHFFFAOYSA-N 0.000 claims 1
- RDAFNSMYPSHCBK-UHFFFAOYSA-N 3-phenylprop-2-en-1-amine Chemical compound NCC=CC1=CC=CC=C1 RDAFNSMYPSHCBK-UHFFFAOYSA-N 0.000 claims 1
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 claims 1
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 claims 1
- 229920002126 Acrylic acid copolymer Polymers 0.000 claims 1
- GFFGJBXGBJISGV-UHFFFAOYSA-N Adenine Chemical compound NC1=NC=NC2=C1N=CN2 GFFGJBXGBJISGV-UHFFFAOYSA-N 0.000 claims 1
- 229930024421 Adenine Natural products 0.000 claims 1
- 241000352333 Amegilla alpha Species 0.000 claims 1
- NOWKCMXCCJGMRR-UHFFFAOYSA-N Aziridine Chemical compound C1CN1 NOWKCMXCCJGMRR-UHFFFAOYSA-N 0.000 claims 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 claims 1
- CPELXLSAUQHCOX-UHFFFAOYSA-M Bromide Chemical compound [Br-] CPELXLSAUQHCOX-UHFFFAOYSA-M 0.000 claims 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims 1
- 229920001661 Chitosan Polymers 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 1
- SNRUBQQJIBEYMU-UHFFFAOYSA-N Dodecane Natural products CCCCCCCCCCCC SNRUBQQJIBEYMU-UHFFFAOYSA-N 0.000 claims 1
- BRLQWZUYTZBJKN-UHFFFAOYSA-N Epichlorohydrin Chemical compound ClCC1CO1 BRLQWZUYTZBJKN-UHFFFAOYSA-N 0.000 claims 1
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 claims 1
- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 1
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 claims 1
- FKNQFGJONOIPTF-UHFFFAOYSA-N Sodium cation Chemical compound [Na+] FKNQFGJONOIPTF-UHFFFAOYSA-N 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 229960000643 adenine Drugs 0.000 claims 1
- 125000005210 alkyl ammonium group Chemical group 0.000 claims 1
- 125000005907 alkyl ester group Chemical group 0.000 claims 1
- 125000000217 alkyl group Chemical group 0.000 claims 1
- 150000001350 alkyl halides Chemical class 0.000 claims 1
- 230000029936 alkylation Effects 0.000 claims 1
- 238000005804 alkylation reaction Methods 0.000 claims 1
- 150000001412 amines Chemical class 0.000 claims 1
- 235000001014 amino acid Nutrition 0.000 claims 1
- 229940024606 amino acid Drugs 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 150000004982 aromatic amines Chemical class 0.000 claims 1
- 238000005574 benzylation reaction Methods 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 229910001424 calcium ion Inorganic materials 0.000 claims 1
- 150000001732 carboxylic acid derivatives Chemical class 0.000 claims 1
- 229960004203 carnitine Drugs 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 239000007910 chewable tablet Substances 0.000 claims 1
- 229940068682 chewable tablet Drugs 0.000 claims 1
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 claims 1
- 229960001231 choline Drugs 0.000 claims 1
- 238000005354 coacervation Methods 0.000 claims 1
- 210000001072 colon Anatomy 0.000 claims 1
- 229960003624 creatine Drugs 0.000 claims 1
- 239000006046 creatine Substances 0.000 claims 1
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 claims 1
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 claims 1
- AFOSIXZFDONLBT-UHFFFAOYSA-N divinyl sulfone Chemical compound C=CS(=O)(=O)C=C AFOSIXZFDONLBT-UHFFFAOYSA-N 0.000 claims 1
- 125000003438 dodecyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 claims 1
- 239000012039 electrophile Substances 0.000 claims 1
- 238000010931 ester hydrolysis Methods 0.000 claims 1
- UYMKPFRHYYNDTL-UHFFFAOYSA-N ethenamine Chemical compound NC=C UYMKPFRHYYNDTL-UHFFFAOYSA-N 0.000 claims 1
- BNKAXGCRDYRABM-UHFFFAOYSA-N ethenyl dihydrogen phosphate Chemical compound OP(O)(=O)OC=C BNKAXGCRDYRABM-UHFFFAOYSA-N 0.000 claims 1
- 239000012530 fluid Substances 0.000 claims 1
- 150000002222 fluorine compounds Chemical group 0.000 claims 1
- 229960004198 guanidine Drugs 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 239000012669 liquid formulation Substances 0.000 claims 1
- 229910001425 magnesium ion Inorganic materials 0.000 claims 1
- ZIUHHBKFKCYYJD-UHFFFAOYSA-N n,n'-methylenebisacrylamide Chemical compound C=CC(=O)NCNC(=O)C=C ZIUHHBKFKCYYJD-UHFFFAOYSA-N 0.000 claims 1
- 150000002924 oxiranes Chemical class 0.000 claims 1
- 235000019629 palatability Nutrition 0.000 claims 1
- 229920005597 polymer membrane Polymers 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 229910001414 potassium ion Inorganic materials 0.000 claims 1
- 238000005070 sampling Methods 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 229910001415 sodium ion Inorganic materials 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000010557 suspension polymerization reaction Methods 0.000 claims 1
- 238000003786 synthesis reaction Methods 0.000 claims 1
- 229960003080 taurine Drugs 0.000 claims 1
- ZTWTYVWXUKTLCP-UHFFFAOYSA-N vinylphosphonic acid Chemical compound OP(O)(=O)C=C ZTWTYVWXUKTLCP-UHFFFAOYSA-N 0.000 claims 1
- 208000001647 Renal Insufficiency Diseases 0.000 abstract 1
- 201000006370 kidney failure Diseases 0.000 abstract 1
- 230000000069 prophylactic effect Effects 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
Classifications
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- C—CHEMISTRY; METALLURGY
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- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F120/00—Homopolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical or a salt, anhydride, ester, amide, imide or nitrile thereof
- C08F120/02—Monocarboxylic acids having less than ten carbon atoms; Derivatives thereof
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- C08F120/06—Acrylic acid; Methacrylic acid; Metal salts or ammonium salts thereof
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- C08F128/00—Homopolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a bond to sulfur or by a heterocyclic ring containing sulfur
- C08F128/02—Homopolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a bond to sulfur or by a heterocyclic ring containing sulfur by a bond to sulfur
Abstract
The present invention provides methods and compositions for the treatment of ion imbalances. In particular, the invention provides compositions comprising potassium binding polymers and pharmaceutical compositions thereof. Methods of use of the polymeric and pharmaceutical compositions for therapeutic and/or prophylactic benefits are disclosed herein. Examples of these methods include the treatment of hyperkalemia, such as hyperkalemia caused by renal failure and/or the use of hyperkalemia causing drugs.
Claims (58)
1. A method of removing potassium from an animal subject need thereof comprising administering to said animal subject in an effective amount of a potassium-binding polymer, said polymer being capable of binding and removing from a gastrointestinal tract of said animal subject an average of about 1.5 mmol of potassium per gm of said polymer.
2. A method of removing potassium from an animal subject in need thereof comprising administering to said animal subject an effective amount of a potassium-binding polymer, said polymer having an in vitro potassium binding capacity of greater than about 5 mmol/gm of said polymer at a pH of greater than about 5.5.
3. A method of removing potassium from an animal subject in need thereof comprising administering to said animal subject an effective amount of a potassium-binding polymer, said polymer having an average in vivo potassium binding capacity of at least about 1.5 mmol/gm of said polymer.
4. A method of removing potassium from an animal subject in need thereof comprising administering to said animal subject an effective amount of a core-shell composition comprising a potassium-binding polymer and a shell, said shell being physically and/or chemically attached to said potassium-binding polymer.
5. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer is in a Ca2+-form, a H+-form, a NH4+-form, a Na+-form, or a combination thereof.
6. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer comprises a non metallic positively charged counter-ion.
7. The method of claim 6 wherein said non metallic positively charged counter-ion is at least one of an ion selected from alkylammonium, hydroxyalkylammonium, choline, taurine, carnitine, guanidine, creatine, adenine, and aminoacids or derivatives thereof.
8. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer comprises at least one polymer selected from an optionally crosslinked carboxylic polymer, an optionally crosslinked sulfonic polymer, an optionally crosslinked sulfamic polymer, an optionally crosslinked phosphoric polymer, and an anhydride thereof.
9. The method of claim 4 wherein said potassium-binding polymer is a polystyrene sulfonate.
10. The method of claim 8 wherein said potassium-binding polymer comprises a pK a-decreasing group attached to an acid group of said polymer.
11. The method of claim 10 wherein said pK a-decreasing group is an electron-withdrawing group.
12. The method of claim 11 wherein said electron-withdrawing group is a halide or an OR
group, wherein R is H or alkyl.
group, wherein R is H or alkyl.
13. The method of claim 12 wherein said halide atom is fluoride, chloride, or bromide.
14. The method of claim 8 wherein said potassium binding polymer comprises a poly-fluoroacrylic acid polymer, a poly-difluoromaleic acid polymer, or a combination thereof.
15. The method of claim 14 wherein said potassium binding polymer comprises 2-fluoroacrylic acid crosslinked with divinylbenzene, ethylene bisacrylamide, N,N'-bis(vinylsulfonylacetyl) ethylene diamine, 1,3-bis(vinylsulfonyl) 2-propanol, vinylsulfone, N,N'-methylenebisacrylamide, or a combination thereof.
16. The method of claim 15 wherein said potassium binding polymer comprises crosslinked 2-fluoroacrylic polymer or co-polymer, said polymer or co-polymer obtained by polymerization of an alkylester of 2-fluoroacrylic acid with divinylbenzene and followed by ester hydrolysis.
17. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer is at least one polymer selected from an optionally crosslinked 2-fluroacrylate polymer, an optionally crosslinked vinyl sulfonic acid polymer, and an optionally crosslinked vinyl phosphoric acid polymer.
18. The method of claim 4 wherein said potassium binding polymer comprises at least one polymer selected from an optionally crosslinked carboxylic, phosphoric, or sulfonic acid, or combination thereof and said shell comprises a positively charged polymer with low permeability to multivalent cations.
19. The method of claim 4 wherein said potassium binding polymer comprises an optionally crosslinked 2-fluoroacrylic and acrylic acid copolymer and said shell comprises a positively charged polymer with low permeability to multivalent cations.
20. The method of claim 18 wherein said shell comprises copolymers, at least one repeat unit of said copolymer being a vinylamine, ethyleneimine, propyleneimine, allylamine, methallylamine, vinylpyridine, alkyaminoalkyl(meth)acrylate, alkyaminoalkyl(meth)acrylamide, aminomethylstyrene, chitosan, or adduct of aliphatic or aromatic amine with at least one electrophile selected from an epichlorhydrine, an alkylhalide, and an epoxide, wherein the amine is optionally a quarternized form.
21. The method of claim 4 wherein said shell comprises an enteric coating, said coating being capable of disintegrating in a colon.
22. The method of claim 21 wherein said shell further comprises a non-enteric coating.
23. The method of claim 4 wherein said shell inhibits a binding of multi-valent cations to said potassium-binding polymer.
24. The method of claim 4 wherein said shell is coated on said potassium-binding polymer by a fluidized bed coating process
25. The method of claim 4 wherein said shell is positively charged.
26. The method of claim 4 wherein said shell enhances the oral palatability of said potassium-binding polymer.
27. The method of claim 4 wherein said shell comprises a polyethyleneimine polymer.
28. The method of claim 4 wherein said shell inhibits binding of a competing ion to said potassium-binding polymer.
29. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer preferentially binds a potassium ion over a competing ion, said competing ion being a sodium ion, a calcium ion, a magnesium ion, or a combination thereof.
30. The method of claim 1, 2, 3, or 4 wherein said animal subject is suffering from hyperkalemia.
31. The method of claim 1, 2, 3, or 4 wherein said potassium binding polymer is co-administered with a drug that promotes potassium retention.
32. The method of claim 1, 2, 3, or 4 wherein said composition is co-administered with an ACE inhibitor, an ARB, a potassium sparing diuretic, or any combination thereof.
33. The method of claim 1, 2, 3, or 4 wherein said potassium-binding polymer is combined with at least one pharmaceutically acceptable excipient to form a pharmaceutical formulation.
34. The method of claim 33 wherein said pharmaceutical formulation is an oral or rectal formulation.
35. The method of claim 34 wherein said oral formulation is a liquid formulation or a chewable tablet formulation.
36. A pharmaceutical formulation comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises a crosslinked carboxylic polymer or an anhydride thereof with a pK a-decreasing group.
37. The pharmaceutical formulation of claim 36 wherein said potassium binding polymer comprises a crosslinked poly-fluoroacrylic acid polymer, a crosslinked poly-difluoromaleic acid polymer, or a combination thereof.
38. The pharmaceutical formulation of claim 37 wherein said potassium binding polymer comprises 2-fluoroacrylic acid crosslinked with divinylbenzene, ethylene bisacrylamide, or a combination thereof.
39. A pharmaceutical formulation comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises an optionally crosslinked .alpha.-fluroacrylate polymer, an optionally crosslinked vinyl sulfonic acid polymer, an optionally crosslinked vinyl phosphonic acid polymer, or a combination thereof.
40. A method of treating a disease comprising administering to an animal subject in need thereof an effective amount of a pharmaceutical composition of claim 36.
41. A method of determining a permeability of said shell of claim 4 to an ion comprising:
(a) attaching a composite membrane to a tube containing a donor solution, said composite membrane comprising said shell and a cellulose membrane and said donor solution comprising said ion;
(b) immersing said tube in an acceptor solution, said acceptor solution comprising said ion;
(c) sampling and analyzing said acceptor solution for said ion;
(d) determining a change in concentration of said ion in said acceptor solution;
said change in concentration being indicative of said permeability of said polymer membrane to said ion.
(a) attaching a composite membrane to a tube containing a donor solution, said composite membrane comprising said shell and a cellulose membrane and said donor solution comprising said ion;
(b) immersing said tube in an acceptor solution, said acceptor solution comprising said ion;
(c) sampling and analyzing said acceptor solution for said ion;
(d) determining a change in concentration of said ion in said acceptor solution;
said change in concentration being indicative of said permeability of said polymer membrane to said ion.
42. The method of claim 1, 2, 3 or 4 wherein less than 1% of said potassium-binding polymer can be absorbed from a gastrointestinal tract
43. A pharmaceutical compositon comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises a a fluoroacrylate polymer crosslinked with divinyl benzene.
44. A method of treating a disease comprising administering to an animal subject in need thereof an effective amount of a pharmaceutical composition of claim 43.
45. A core-shell composition comprising a core and a shell, said core comprising a potassium binding polymer selected from polystyrene sulfonate or a fluoroacrylate polymer crosslinked with divinyl benzene and said shell comprising Eudragit RL 100, Eudragit RS
100, a combination thereof, benzylated polyethyleneimine, or N-dodecyl polyethyleneimine.
100, a combination thereof, benzylated polyethyleneimine, or N-dodecyl polyethyleneimine.
46. The composition of claim 45 wherein said shell comprises a mixture of Eudragit RL
100 and Eudragit RS 100 in a ratio of about 50: about 50.
100 and Eudragit RS 100 in a ratio of about 50: about 50.
47. The composition of claim 45 wherein said shell comprises benzylated polyethyleneimine with a degree of benzylation being about 20% to about 99% of nitrogen mole content.
48. The composition of claim 45 wherein said shell comprises N-dodecyl polyethyleneimine with a degree of dodecyl alkylation being about 20% to about 99% of nitrogen mole content.
49. The composition of claim 45 wherein said core-shell composition is synthesized by a Wurster fluid bed coating process or a controlled coating precipitation process.
50. The composition of claim 49 wherein said controlled coating precipitation process is a solvent coacervation process, a pH triggered precipitation process, or temperature triggered precipitation process.
51. A method of treating a disease comprising administering to an animal subject in need thereof an effective amount of a core-shell composition of claim 45.
52. A method of removing potassium from an animal subject comprising administering to said animal subject in need thereof an effective amount of a pharmaceutical composition comprising a potassium-binding polymer and a pharmaceutically acceptable excipient, wherein said potassium-binding polymer comprises a a fluoroacrylate polymer crosslinked with divinyl benzene.
53. A method of removing potassium from an animal subject in need thereof comprising administering to said animal subject an effective amount of a core-shell composition comprising a core and a shell, said core comprising a potassium binding polymer selected from polystyrene sulfonate or a fluoroacrylate polymer crosslinked with divinyl benzene and said shell comprising Eudragit RL 100, Eudragit RS 100, a combination thereof, or benzylated polyethyleneimine.
54. The method of claim 52 or 53 wherein said animal subject is suffering from hyperkalemia.
55. The method of claim 52 or 53 wherein said composition is co-administered with a drug that promotes potassium retention.
56. The method of claim 52 or 53 wherein said composition is co-administered with an ACE inhibitor, an ARB, a potassium sparing diuretic, or any combination thereof.
57. A method of synthesis of .alpha.-fluoroacrylate polymer comprising suspension polymerization of a .alpha.-fluoroacrylate monomerin the presence of a low water soluble free radical initiator and a water soluble salt.
58. The method of claim 57 wherein said low water soluble free radical initiator is lauryl peroxide and said water soluble salt is sodium chloride.
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