HRP20171590T1 - Polimeri koji vežu protone za oralnu primjenu - Google Patents
Polimeri koji vežu protone za oralnu primjenu Download PDFInfo
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- HRP20171590T1 HRP20171590T1 HRP20171590TT HRP20171590T HRP20171590T1 HR P20171590 T1 HRP20171590 T1 HR P20171590T1 HR P20171590T T HRP20171590T T HR P20171590TT HR P20171590 T HRP20171590 T HR P20171590T HR P20171590 T1 HRP20171590 T1 HR P20171590T1
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- 229920000642 polymer Polymers 0.000 title claims 24
- 229910052739 hydrogen Inorganic materials 0.000 claims 33
- 239000001257 hydrogen Substances 0.000 claims 33
- 150000002431 hydrogen Chemical class 0.000 claims 29
- 239000000825 pharmaceutical preparation Substances 0.000 claims 24
- 125000001183 hydrocarbyl group Chemical group 0.000 claims 22
- 150000001412 amines Chemical class 0.000 claims 20
- 125000001931 aliphatic group Chemical group 0.000 claims 14
- 239000008194 pharmaceutical composition Substances 0.000 claims 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 10
- 125000004103 aminoalkyl group Chemical group 0.000 claims 10
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 claims 9
- 125000001072 heteroaryl group Chemical group 0.000 claims 9
- 125000003903 2-propenyl group Chemical group [H]C([*])([H])C([H])=C([H])[H] 0.000 claims 8
- 125000003277 amino group Chemical group 0.000 claims 7
- 125000003118 aryl group Chemical group 0.000 claims 7
- SXGZJKUKBWWHRA-UHFFFAOYSA-N 2-(N-morpholiniumyl)ethanesulfonate Chemical compound [O-]S(=O)(=O)CC[NH+]1CCOCC1 SXGZJKUKBWWHRA-UHFFFAOYSA-N 0.000 claims 6
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical group CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims 6
- 239000000872 buffer Substances 0.000 claims 6
- 208000010444 Acidosis Diseases 0.000 claims 5
- 125000000217 alkyl group Chemical group 0.000 claims 5
- 125000001188 haloalkyl group Chemical group 0.000 claims 5
- 239000011780 sodium chloride Substances 0.000 claims 5
- 229920002554 vinyl polymer Polymers 0.000 claims 5
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 4
- 206010027417 Metabolic acidosis Diseases 0.000 claims 4
- 230000002452 interceptive effect Effects 0.000 claims 4
- 150000002500 ions Chemical class 0.000 claims 4
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 claims 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 3
- 102000006335 Phosphate-Binding Proteins Human genes 0.000 claims 3
- 108010058514 Phosphate-Binding Proteins Proteins 0.000 claims 3
- 125000003342 alkenyl group Chemical group 0.000 claims 3
- 125000000623 heterocyclic group Chemical group 0.000 claims 3
- 125000002768 hydroxyalkyl group Chemical group 0.000 claims 3
- 235000019799 monosodium phosphate Nutrition 0.000 claims 3
- 210000002966 serum Anatomy 0.000 claims 3
- 210000000813 small intestine Anatomy 0.000 claims 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 3
- 229910000162 sodium phosphate Inorganic materials 0.000 claims 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 2
- 239000012062 aqueous buffer Substances 0.000 claims 2
- ZADPBFCGQRWHPN-UHFFFAOYSA-N boronic acid Chemical compound OBO ZADPBFCGQRWHPN-UHFFFAOYSA-N 0.000 claims 2
- 239000008367 deionised water Substances 0.000 claims 2
- 229910021641 deionized water Inorganic materials 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 230000002496 gastric effect Effects 0.000 claims 2
- 125000004356 hydroxy functional group Chemical group O* 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 2
- 229910052700 potassium Inorganic materials 0.000 claims 2
- 239000011591 potassium Substances 0.000 claims 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 2
- 229910052708 sodium Inorganic materials 0.000 claims 2
- 239000011734 sodium Substances 0.000 claims 2
- 230000008961 swelling Effects 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- MALIONKMKPITBV-UHFFFAOYSA-N 2-(3-chloro-4-hydroxyphenyl)-n-[2-(4-sulfamoylphenyl)ethyl]acetamide Chemical compound C1=CC(S(=O)(=O)N)=CC=C1CCNC(=O)CC1=CC=C(O)C(Cl)=C1 MALIONKMKPITBV-UHFFFAOYSA-N 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- 230000007950 acidosis Effects 0.000 claims 1
- 208000026545 acidosis disease Diseases 0.000 claims 1
- 125000002723 alicyclic group Chemical group 0.000 claims 1
- 125000001589 carboacyl group Chemical group 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 239000003431 cross linking reagent Substances 0.000 claims 1
- 229910052736 halogen Inorganic materials 0.000 claims 1
- 125000001475 halogen functional group Chemical group 0.000 claims 1
- 150000002367 halogens Chemical class 0.000 claims 1
- 125000004404 heteroalkyl group Chemical group 0.000 claims 1
- -1 hydroxy, amino Chemical group 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 238000010526 radical polymerization reaction Methods 0.000 claims 1
- 229930195734 saturated hydrocarbon Chemical group 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 230000002459 sustained effect Effects 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F226/00—Copolymers 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 single or double bond to nitrogen or by a heterocyclic ring containing nitrogen
- C08F226/02—Copolymers 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 single or double bond to nitrogen or by a heterocyclic ring containing nitrogen by a single or double bond to nitrogen
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G73/00—Macromolecular compounds obtained by reactions forming a linkage containing nitrogen with or without oxygen or carbon in the main chain of the macromolecule, not provided for in groups C08G12/00 - C08G71/00
- C08G73/02—Polyamines
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G73/00—Macromolecular compounds obtained by reactions forming a linkage containing nitrogen with or without oxygen or carbon in the main chain of the macromolecule, not provided for in groups C08G12/00 - C08G71/00
- C08G73/02—Polyamines
- C08G73/024—Polyamines containing oxygen in the form of ether bonds in the main chain
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
- G01N2001/4083—Concentrating samples by other techniques involving separation of suspended solids sedimentation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
- G01N2001/4088—Concentrating samples by other techniques involving separation of suspended solids filtration
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
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- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Obesity (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Addition Polymer Or Copolymer, Post-Treatments, Or Chemical Modifications (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)
- Macromolecular Compounds Obtained By Forming Nitrogen-Containing Linkages In General (AREA)
Claims (30)
1. Farmaceutski pripravak za upotrebu u postupku liječenja metaboličke acidoze oralnim davanjem navedenog farmaceutskog pripravka, te navedeni pripravak sadrži umreženi aminski polimer koji veže protone koji sadrži aminski ostatak koji odgovara formuli 1:
[image]
naznačen time da
R1, R2 i R3 su neovisno vodik, hidrokarbil, supstituirani hidrokarbil, uz uvjet da je ipak najmanje jedan od R1, R2 i R3 različit od vodika,
umreženi aminski polimer ima ravnotežni omjer bubrenja u deioniziranoj vodi od 5 ili niži; umreženi aminski polimer veže odgovarajući molarni odnos kloridnih iona prema ometajućim ionima od najmanje 0,35:1, u puferu s ometajućim ionima na 37°C pri čemu su ometajući ioni fosfatni ioni i ometajući ionski pufer je otopina na pH 5,5 36mM klorida i 20mM fosfata.
2. Farmaceutski pripravak za upotrebu prema zahtjevu 1, naznačen time da umreženi aminski polimer ima ravnotežni odnos bubrenja u deioniziranoj vodi od 4 ili manji, ili 3 ili manji, ili 2 ili manji, ili 1,5 ili manji, ili 1 ili manji.
3. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva naznačen time da su R1, R2 i R3 neovisno vodik, alkil, alkenil, alil, vinil, aril, aminoalkil, alkanol, haloalkil, hidroksialkil, eterski, heteroaril ili heterociklički ostatak uz uvjet da ipak svaki od R1, R2 i R3 nije vodik, ili određenije farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva gdje su R1, R2 i R3 neovisno vodik, alifatski ili heteroalifatski ostatak, međutim najmanje jedan od R1, R2 i R3 je različit od vodika.
4. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 1-3, naznačen time da umreženi aminski polimer sadrži ostatak amina koji odgovara formuli 1a i umreženi aminski polimer je dobiven radikalnom polimerizacijom amina koji odgovara formuli 1a:
[image]
pri čemu R4 i R5 su neovisno vodik, hidrokarbil ili supstituirani hidrokarbil.
5. Farmaceutski pripravak za upotrebu prema zahtjevu 4, naznačen time da R4 i R5su neovisno vodik, alkil, alkenil, alili, vinil, aril, aminoalkil, alkanol, haloalkil, hidroksialkil, eterski, heteroarilni ili heterociklički ostatak iliodređenije farmaceutska pripravak prema zahtjevu 4, pri čemu R4 i R5 su neovisno vodik, alifatski ili heteroalifatski ostatak.
6. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 1-3, naznačen time da umreženi aminski polimer sadrži ostatak amina koji odgovara formuli 1b i umreženi aminski polimer je dobiven supstitucijskom polimerizacijom amina koji odgovara formuli 1b s polifunkcionalnim sredstvom za umrežavanje:
[image]
pri čemu R4 i R5 su neovisno vodik, hidrokarbil ili supstituirani hidrokarbil, R6 je alifatski i R61 i R62 su neovisno vodik, alifatski ili heteroalifatski ostatak.
7. Farmaceutski pripravak za upotrebu prema zahtjevu 6, naznačen time da R4 i R5 su neovisno vodik, zasićeni ugljikovodik, nezasićeni alifatski ostatak, aril, heteroaril, heteroalkil ili nezasićeni heteroalifatski ostatak ili specifičnije farmaceutski pripravak prema zahtjevu 6, pri čemu R4i R5 su neovisno vodik, alkil, alkenil, alil, vinil, aril, aminoalkil, alkanol, haloalkil, hidroksialkil, eterski, heteroarilni ili heterociklički ostatak ili određenije farmaceutski pripravak prema zahtjevu 6, pri čemu R4 i R5 su neovisno vodik, alil i aminoalkil.
8. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva u kojima umreženi aminski polimer sadrži ostatak amina koji odgovara formuli 1C:
[image]
naznačen time da R7 je vodik, alifatski ili heteroalifatski ostatak i R8 je alifatski ili heteroalifatski ostatak.
9. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 1-3, naznačen time da umreženi aminski polimer sadrži ostatak amina koji odgovara formuli 2:
[image]
pri čemu
m i n su neovisno ne negativni cijeli brojevi;
R10, R20, R30 i R40 su neovisno vodik, hidrokarbil ili supstituirani hidrokarbil;
X1 je
[image]
X2 je hidrokarbil ili supstituirani hidrokarbil;
svaki X11 je neovisno vodik, hidrokarbil, supstituirani hidrokarbil, hidroksi ili amino; i
z je ne negativni broj.
10. Farmaceutski pripravak za upotrebu prema zahtjevu 9, naznačen time da R10, R20, R30 i R40 su neovisno vodik, alifatski, aril, heteroalifatski ostatak ili heteroaril, m i z su neovisno 0-3 i n je 0 ili 1, i/ili X2 je alifatski ili heteroalifatski ostatak.
11. Farmaceutski pripravak za upotrebu prema zahtjevu 9 ili 10, naznačen time da m je 1-3 i X11 je vodik, alifatski ili heteroalifatski ostatak.
12. Farmaceutski pripravak za upotrebu prema bilo kojem od zahtjeva 1-3, naznačen time da umreženi aminski polimer sadrži aminski ostatak koji odgovara formuli 2a:
[image]
pri čemu
m i n su neovisno ne negativni cijeli brojevi;
svaki R11 je neovisno vodik, hidrokarbil, heteroalifatski ili heteroaril;
R21 i R31 su neovisno vodik ili heteroalifatski ostatak;
R41 je vodik, supstituirani hidrokarbil ili hidrokarbil:
X1 je
[image]
X2 je alkil ili supstituirani hidrokarbil:
svaki X12 je neovisno vodik, hidroksi, amino, aminoalkil, boronska kiselina ili halo; i
z je ne negativni broj.
13. Farmaceutski pripravak za upotrebu prema zahtjevu 12, naznačen time da m i z su neovisno 0-3 i n je 0 ili 1.
14. Farmaceutski pripravak za upotrebu prema zahtjevu 12 ili 13, naznačen time da R11 je neovisno vodik, alifatski ostatak, aminoalkil, haloalkil, ili heteroaril, R21 i R31 su neovisno vodik ili heteroalifatski ostatak i R41 je vodik, alifatski, aril, heteroalifatski ostatak ili heteroaril ili određenije farmaceutski pripravak prema zahtjevu 12 ili 13 pri čemu svaki R11 je vodik, alifatski ostatak, aminoalkil ili haloalkil, R21 i R31 su vodik ili aminoalkil i R41 je vodik, alifatski ili heteroalifatski ostatak.
15. Farmaceutski pripravak za upotrebu prema zahtjevu 1-3, naznačen time da umreženi aminski polimer sadrži aminski ostatak koji odgovara formuli 2b:
[image]
pri čemu
m i n su neovisno ne negativni cijeli brojevi;
svaki R12 je neovisno vodik, supstituirani hidrokarbil ili hidrokarbil;
R22 i R32 su neovisno vodik, supstituirani hidrokarbil ili hidrokarbil;
R42 je vodik, hidrokarbil ili supstituirani hidrokarbil;
X1 je
[image]
X2 je alkil, aminoalkil ili alkanoil;
svaki X13 je neovisno vodik, hidroksi, aliciklički ostatak, amino, aminoalkil, halogen, heteroaril, boronska kiselina ili aril;
z je ne negativni broj; i
amin koji odgovara formuli 2b sadrži najmanje jednu alil skupinu.
16. Farmaceutski pripravak za upotrebu prema zahtjevu 15, naznačen time da m i z su neovisno 0-3 i n je 0 ili 1.
17. Farmaceutski pripravak za upotrebu prema zahtjevu 15 ili 16, naznačen time da R12 ili R42 neovisno sadrže najmanje jedan alil ili vinil ostatak, ili farmaceutski pripravak prema zahtjevu 15 ili 16 pri čemu (i) m je pozitivni cijeli broj i R12, R22 i R42 u kombinaciji sadrže najmanje dva alil ili vinil ostatka ili (ii) n je pozitivan cijeli broj i R12, R22 i R42 u kombinaciji, sadrži najmanje dva alil ili vinil ostatka.
18. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da umreženi aminski polimer ima odgovarajući molarni omjer vezanja kloridnog iona prema fosfatnom od najmanje 0,5 : 1, u vodenom neorganskom puferu koji simulira tanko crijevo ("SIB") koji sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) puferiran na pH 5,5 i na 37 °C.
19. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva, naznačen time da umreženi aminski polimer ima odgovarajući molarni omjer vezanja kloridnog iona prema fosfatnom od najmanje 1:1, u vodenom neorganskom puferu koji simulira tanko crijevo ("SIB") koji sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) puferiran na pH 5,5 i na 37 °C.
20. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva naznačen time da umreženi aminski polimer ima odgovarajući molarni omjer vezanja kloridnog iona prema fosfatnom od najmanje 2:1, u vodenom neorganskom puferu koji simulira tanko crijevo ("SIB") koji sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) puferiran na pH 5,5 i na 37 °C.
21. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva naznačen time da umreženi aminski polimer ima kapacitet vezanja protona od najmanje 10 mmol/g i kapacitet vezanja kloridnog iona od najmanje 10 mmol/g u vodenom puferu koji simulira želučanu tekućinu ("SGF") koji sadrži 35 mM NaCl i 63 mM HCl na pH 1,2 i 37 °C.
22. Farmaceutski pripravak za upotrebu prema bilo kojem od prethodnih zahtjeva naznačen time da umreženi aminski polimer ima ravnotežni kapacitet vezanja protona od najmanje 12 mmol/g i kapacitet vezanja kloridnog iona od najmanje 12 mmol/g , ili ravnotežni kapacitet vezanja protona od najmanje 14 mmol/g i kapacitet vezanja kloridnog iona od najmanje 14 mmol/g u vodenom puferu koji simulira želučanu tekućinu ("SGF") koji sadrži 35 mM NaCl i 63 mM HCl na pH 1,2 i 37 °C.
23. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu naznačen time da je vezanje klorida u SIB testu nakon jednog sata izlaganja polimera testnom puferu na 37 °C veće od 2,0 mmol po gramu polimera, ili veće od 2,5 mmol/g polimera, ili veće od 3,0 mmol/g polimera, ili veće od 3,5 mmol/g polimera ili veće od 4,00 mmol/g polimera.
24. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, naznačen time da se primjenjuje manje od 1 g, 0,5 g ili 0,1 natrija ili kalija dnevno, ili pri čemu se ne daje natrij ili kalij.
25. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, naznačen time da je primijenjena dnevna doza manja od 20 g, ili manja od 15 g, ili manja od 10 g, ili manja od 5 g, ili manja od 4 g ,ili manja od 3 g.
26. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, naznačen time da se dnevna doza daje jednom dnevno, ili dva puta dnevno ili tri puta dnevno.
27. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu naznačen time da je metabolička acidoza kronična metabolička acidoza.
28. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu naznačen time da dnevna doza dovodi do održanog porasta bikarbonata u serumu od ≥1,6 mEq/L, ili ≥2 mEq/L, ili ≥3 mEq/L, ili ≥5 mEq/L, ili ≥10 mEq/L.
29. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, naznačen time da je u navedenom postupku doza titrirana na osnovi vrijednosti bikarbonata u serumu pacijenta kojem je potrebno liječenje ili drugim indikatorima acidoze.
30. Farmaceutski pripravak za upotrebu prema bilo kojem prethodnom zahtjevu, gdje je metabolička acidoza naznačena time što je vrijednost bikarbonata u serumu manja od 22 mEq/L.
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