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HRP20201767T1 - Polimeri koji vežu protone za oralnu primjenu - Google Patents

Polimeri koji vežu protone za oralnu primjenu Download PDF

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HRP20201767T1
HRP20201767T1 HRP20201767TT HRP20201767T HRP20201767T1 HR P20201767 T1 HRP20201767 T1 HR P20201767T1 HR P20201767T T HRP20201767T T HR P20201767TT HR P20201767 T HRP20201767 T HR P20201767T HR P20201767 T1 HRP20201767 T1 HR P20201767T1
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bis
cross
pharmaceutical composition
use according
amine
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HRP20201767TT
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Gerrit Klaerner
Eric F. Connor
Randi K. Gbur
Matthew J. Kade
Paul H. Kierstead
Jerry M. Buysse
Michael J. Cope
Kalpesh N. Biyani
Son H. Nguyen
Scott M. Tabakman
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Tricida Inc.
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Publication of HRP20201767T1 publication Critical patent/HRP20201767T1/hr

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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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • 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 (18)

1. Farmaceutski sastav za upotrebu u liječenju metaboličke acidoze, gdje farmaceutski sastav sadrži umreženi aminski polimer koji veže protone koji sadrži ostatak amina koji odgovara Formuli 2b i umreženi aminski polimer je dobiven radikalskom polimerizacijom amina koji odgovara formuli 2b: [image] gdje m i n su nezavisno ne-negativni cijeli brojevi; svaki R12 je nezavisni vodik, supstituirani hidrokarbil ili hidrokarbil; R22 i R32 su nezavisni vodik, supstituirani hidrokarbil ili hidrokarbil; R42 je vodik, hidrokarbil ili supstituirani hidrokarbil; X1 je [image] X2 je alkil, aminoalkil ili alkanol; svaki X13 je nezavisni vodik, hidroksi, alicikličan, amino, aminoalkil, halogen, alkil, heteroaril, boronska kiselina ili aril; z je broj koji nije negativan; i amin koji odgovara Formuli 2b sadrži najmanje jednu alil grupu i umreženi aminski polimer ima (i) ravnotežni kapacitet vezivanja protona od najmanje 5 mmol/g i kapacitet vezivanja kloridnih iona od najmanje 5 mmol/g, u vodenom puferu simulirane želučane tekućine ("SGF") koji sadrži 35 mM NaCl i 63 mM HCl, pri pH 1,2 i na 37°C, (ii) ravnotežni odnos bubrenja u deioniziranoj vodi od oko 2 ili manje i (iii) vezivanje klorida veće od 2.0 mmol po gramu polimera u SIB testu (testu simuliranog neorganskog pufera tankog crijeva ("SIB", od engl. Simulated Small Intestine Inorganic Buffer)) poslije jednog sata izlaganja polimera puferu za SIB test koji sadrži sadrži 36 mM NaCl, 20 mM NaH2PO4 i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) i podešen na pH 5,5, na 37°C.
2. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1, što umreženi aminski polimer ima vezivanje klorida koje je veće od (i) 2,5 mmol/g polimera, (ii) 3,0 mmol/g polimera, (iii) 3,5 mmol/g polimera ili (iv) 4,0 mmol/g polimera u SIB testu poslije jednog sata izlaganja polimera puferu za SIB test koji sadrži 36mM NaCl, 20 mM NaH2PO4, 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) podešenog na pH 5.5 na 37 °C;
3. Farmaceutski sastav za upotrebu prema patentnom zahtjevu 1 ili 2, gdje su m i z nezavisno 0-3 i n je 0 ili 1.
4. Farmaceutski sastav za upotrebu prema bilo kojem od patentnih zahtjeva 1-3, gdje (i) m je pozitivan cijeli broj i R12, R22 i R42, u kombinaciji, sadrže najmanje dva alilna ili vinilna ostatka ili (ii) n je pozitivan cijeli broj i R12, R32 i R42, u kombinaciji, sadrže najmanje dva alilna ili vinilna ostatka.
5. Farmaceutski sastav za upotrebu prema bilo kojem od patentnih zahtjeva 1-3, gdje je umreženi aminski polimer umrežen sa umrežavajućim agensom izabranim između: bis(3-kloropropil)amina, 1,3-dikloro-2-propanol 1,3-dikloropropana, 1-hloro-2,3-epoksipropana, tris[(2-oksiranil)metil]amina, 3-kloro-1-(3-kloropropilamino)-2-propanola, i 1,2-bis(3-kloropropilamino)etana.
6. Farmaceutski sastav za upotrebu prema bilo kojem od patentnih zahtjeva 1-5, gdje je polimer sintetiziran iz amina i umrežavajućih agenasa, ili njihovih soli, izabran između: 1,4-bis(alilamino)butana, 1,2-bis(alilamino)etana, 2-(alilamino)-1-[2-(alilamino)etilamino]etana, 1,3-bis(alilamino)propana, 1,3-bis(alilamino)-2-propanola, 2-propen-1-ilamina, 1-(alilamino)-2-aminoetana, 1-[N-alil(2-aminoetil)amino]-2-aminoetana, N,N,N-trialilamina.
7. Farmaceutski sastav za upotrebu prema bilo kojem od patentnih zahtjeva 1-4 i 6, gdje je umreženi aminski polimer umrežen umrežavajućim agensom koji može biti korišten u reakcijama supstitucionirane polimerizacije i postpolimerizacionim reakcijama umrežavanja, gdje umrežavajući agens je jedan ili više od: dihaloalkana, haloalkiloksirana, alkiloksiran sulfonata, di(haloalkil)amina, tri(haloalkil) amina, diepoksida, triepoksida, tetraepoksida, bis (halometil)benzena, tri(halometil)benzena, tetra(halometil)benzena, i epihalohidrina.
8. Farmaceutski sastav za upotrebu prema bilo kojem od patentnih zahtjeva 1-4, 6 i 7, gdje je umreženi aminski polimer umrežen umrežavajućim agensom koji može biti korišten u reakcijama supstitucionirane polimerizacije i postpolimerizacionim reakcijama umrežavanja, što je umrežavajući agens jedan ili više od: epiklorohidrin i epibromohidrin poli(epihlorohidrin), (jodometil)oksiran, glicidil tozilat, glicidil 3-nitrobenzensulfonat, 4-toziloksi-1,2-epoksibutan, bromo-1,2-epoksibutan, 1,2-dibromoetan, 1,3-dikloropropan, 1,2-dikloroetan, 1-bromo-2-kloroetan, 1,3-dibromopropan, bis(2-kloroetil)amin, tris(2-kloroetil)amin, bis(2-kloroetil)metilamin, 1,3-butadien diepoksid, 1,5-heksadien diepoksid, diglicidil etar, 1,2,7,8-diepoksioktan, 1,2,9,10-diepoksidekan, etilen glikol diglicidil etar, propilen glikol diglicidil etar, 1,4-butandiol diglicidil etar, 1,2 etandioldiglicidil etar, glicerol diglicidil etar, 1,3-diglicidil gliceril etar, N,N-diglicidilanilin, neopentil glikoldiglicidil etar, dietilen glikol diglicidil etar, 1,4-bis(glicidiloksi)benzen, rezorcinol digilcidil etar, 1,6-heksanediol diglicidil etar, trimetilolpropan diglicidil etar, 1,4-cikloheksandimetanol diglicidil etar, 1,3-bis-(2,3-epoksipropiloksi)-2-(2,3-dihidroksipropiloksi)propan, diglicidil estar 1,2-cikloheksandikarboksilne kiseline, 2,2’-bis(glicidiloksi) difenilmetan, bisfenol F diglicidil etar, 1,4-bis(2’,3’epoksipropil)perfluoro-n-butan, 2,6-di(oksiran-2-ilmeti1)-1,2,3,5,6,7-heksahidropirolo[3,4-f]izoindol-1,3,5,7-tetraon, bisfenol A diglicidil etar, etil 5-hidroksi-6,8-di(oksiran-2-ilmetil)-4-okso-4-h-kromen-2-karboksilat, bis[4-(2,3-epoksi-propiltio)fenil]-sulfid, 1,3-bis(3-glikidoksipropil) tetrametildisiloksan, 9,9-bis[4-(glicidiloksi)fenil]fluorin, triepoksiizocijanurat, glicerol triglicidil etar, N,N-diglicidil-4-glicidiloksianilin, izocijanurinska kiselina (S,S,S)-triglicidil estar, izocijanurinska kiselina (R,R,R)-triglicidil estar, triglicidil izocijanurat, trimetilolpropan triglicidil etar, glicerol propoksilat triglicidil etar, trifenilolmetan triglicidil etar, 3,7,14-tris[[3-(epoksipropoksi)propil]dimetilsililoksi]-1,3,5,7,9,11,14-heptaciklopentiltricikclo [7,3,3,15, 11]heptasiloksan, 4,4 ’metilenbis(N,N-diglicidilanilin), bis(halometil)benzen, bis(halometil)bifenil, bis(halometil)naftalen, toluen diizocijanat, akrilol klorid, metil akrilat, etilen bisakrilamid, pirometalni dianhidrid, sukcinil dihlorid, dimetilsukcinat, 3-kloro-1-(3-kloropropilamino-2-propanol, 1,2-bis(3-kloropropilamino)etan, bis(3-kloropropil)amin, 1,3-dikloro-2-propanol, 1,3-dikloropropan, 1-kloro-2,3-epoksipropan, tris[(2-oksiranil)metil]amin.
9. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje je umreženi aminski polimer pripremljen umrežavanjem intermedijera koji sadrži amin sa polifunkcionalnim umrežavajućim agensom.
10. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje umrežavajući aminski polimer ima ravnotežni odnos bubrenja u deioniziranoj vodi od: (i) 1,5 ili manji, ili (ii) 1 ili manji.
11. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje umrežavajući aminski polimer ima molarni odnos vezivanja kloridnog iona prema fosfatnom ionu od: (i) bar 0,5:1, (ii) bar 1:1, ili (iii) bar 2:1; tim redom, u vodenom simuliranom neorganskom puferu tankog crijeva ("SIB") koji sadrži 36 mM NaCl, 20 mM NaH2PO4 i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) i podešen je do pH 5,5, na 37°C.
12. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje umreženi aminski polimer ima kapacitet vezivanja protona od najmanje 10 mmol/g i kapacitet vezivanja kloridnih iona od najmanje 10 mmol/g, u vodenom puferu simulirane želudačne tekućine ("SGF") koji sadrži 35 mM NaCl i 63 mM HCl, pri pH 1,2 i na 37°C.
13. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje u spomenutom postupku: (i) manje od 1 g natrija ili kalija je davano dnevno; (ii) manje od 0,5 g natrija ili kalija je davano dnevno (iii) manje od 0,1 g natrija ili kalija je davano dnevno ili (iv) nije davan natrij ili kalij.
14. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje u spomenutom postupku je davana dnevna doza manja od: (i) 20g, (ii) 15g, (iii) 10g, (iv) 5g, (v) 4g, ili (vi) 3g.
15. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje je dnevna doza davanja: (i) jednom dnevno, (ii) dva puta dnevno, ili (iii) tri puta dnevno.
16. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje u spomenutom postupku dnevna doza dovodi do održavanog porasta bikarbonata u serumu: (i) ≥1,6 mEq/L, (ii) ≥2 mEq/L, (iii) ≥3 mEq/L, (iv) ≥5 mEq/L, ili (v) ≥10 mEq/L,
17. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje je u spomenutom postupku doza podešavanja na osnovu vrijednosti bikarbonata u serumu pacijenta kojem je potrebno liječenje ili drugih indikatora acidoze.
18. Farmaceutski sastav za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, gdje je metabolička acidoza naznačena time što je vrijednost bikarbonata u serumu manja od 22 mEq/l.
HRP20201767TT 2013-06-05 2020-11-02 Polimeri koji vežu protone za oralnu primjenu HRP20201767T1 (hr)

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US201361831445P 2013-06-05 2013-06-05
EP19169259.9A EP3578185B1 (en) 2013-06-05 2014-06-05 Proton-binding polymers for oral administration

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HRP20171590TT HRP20171590T1 (hr) 2013-06-05 2014-06-05 Polimeri koji vežu protone za oralnu primjenu
HRP20191074TT HRP20191074T1 (hr) 2013-06-05 2019-06-14 Polimeri koji vežu protone za oralnu primjenu
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US (8) US9205107B2 (hr)
EP (4) EP3578185B1 (hr)
JP (5) JP6453860B2 (hr)
KR (5) KR20240152425A (hr)
CN (3) CN105377270B (hr)
AU (3) AU2014274817B2 (hr)
BR (1) BR112015030142B1 (hr)
CA (1) CA2912911C (hr)
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ES (3) ES2646271T3 (hr)
HK (1) HK1251151B (hr)
HR (3) HRP20171590T1 (hr)
HU (3) HUE051198T2 (hr)
IL (3) IL242758B (hr)
LT (3) LT3003327T (hr)
MX (3) MX387845B (hr)
NO (1) NO2905572T3 (hr)
PL (2) PL3287133T3 (hr)
PT (3) PT3578185T (hr)
RS (2) RS59033B1 (hr)
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SI (3) SI3003327T1 (hr)
SM (2) SMT201900391T1 (hr)
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