HRP20210204T1 - Polimeri koji povezuju protone za oralnu primjenu - Google Patents

Polimeri koji povezuju protone za oralnu primjenu Download PDF

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HRP20210204T1
HRP20210204T1 HRP20210204TT HRP20210204T HRP20210204T1 HR P20210204 T1 HRP20210204 T1 HR P20210204T1 HR P20210204T T HRP20210204T T HR P20210204TT HR P20210204 T HRP20210204 T HR P20210204T HR P20210204 T1 HRP20210204 T1 HR P20210204T1
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binding capacity
bis
pharmaceutical composition
mmol
amine polymer
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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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    • 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
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Claims (20)

1. Farmaceutski sastav koji sadrži umreženi aminski polimer koji ima odnos kapaciteta vezivanja kloridnih iona prema kapacitetu vezivanja fosfatnih iona u simuliranom neorganskom puferu tankog crijeva ("SIB") od najmanje 2,3:1, tim redom, pri čemu pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na 5,5, i odnos kapaciteta vezivanja kloridnih iona prema kapacitetu vezivanja fosfatnih iona u SIB je određen pomoću postupka opisanog u opisu pod naslovom Postupak B.
2. Farmaceutski sastav prema zahtjevu 1, u kojem umreženi aminski polimer ima odnos kapaciteta vezivanja kloridnog iona prema kapacitetu vezivanja fosfatnog iona u SIB od najmanje 2,5:1, tim redom, pri čemu pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na 5,5.
3. Farmaceutski sastav prema zahtjevu 1 ili 2, u kojem umreženi aminski polimer ima odnos kapaciteta vezivanja kloridnih iona prema kapacitetu vezivanja fosfatnih iona u SIB : (i) najmanje 3:1, (ii) najmanje 3,5:1, ili (iii) najmanje 4:1; tim redom, pri čemu pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na 5,5.
4. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer ima kapacitet vezivanja kloridnih iona: (i) najmanje 4 mmol/g, (ii) najmanje 4.5 mmol/g, (iii) najmanje 5 mmol/g, (iv) najmanje 5.5 mmol/g, ili (v) najmanje 6 mmol/g; u SIB, pri čemu pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na 5.5, i kapacitet vezivanja kloridnih iona u SIB je određen pomoću postupka opisanog u opisu pod naslovom Postupak B.
5. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer ima odnos bubrenja : (i) manji od 5, (ii) manji od 4, (iii) manji od 3, (iv) manji od 2, (v) manji od 1,5, ili (iv) manji od 1.
6. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer ima kapacitet vezivanja kloridnih iona od najmanje 5 mmol/g u 1-satnom testu simulirane želučane tekućine ("SGF") i kapacitet vezivanja kloridnih iona : (i) najmanje 8 mmol/g, (ii) najmanje 9 mmol/g, (iii) najmanje 10 mmol/g, (iv) najmanje 11 mmol/g, (v) najmanje 12 mmol/g, (vi) najmanje 13 mmol/g, ili (vii) najmanje 14 mmol/g; u 24-satnom SGF testu, u kojem se SGF sastoji od 35 mM NaCl, 63 mM HCl, pH 1,2, i kapacitet vezivanja kloridnih iona u SGF testu je određen pomoću postupka opisanog u opisu pod naslovom Postupak A.
7. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer ima (i) kapacitet vezivanja protona i kapacitet vezivanja klorida bar 5 mmol/g u simuliranoj želučanoj tekućini (SGF); i (ii) kapacitet vezivanja kloridnih iona nakon 1 sata u SIB: (a) najmanje 2 mmol/g, (b) najmanje 2.5 mmol/g, ili (c) najmanje 3 mmol/g; gdje se SGF sastoji od 35 mM NaCl, 63 mM HCl, pH 1,2, i kapacitet vezivanja protona i kapacitet vezivanja klorida u SGF je određen pomoću postupka opisanog u opisu pod naslovom Postupak A, i pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na pH 5,5, i kapacitet vezivanja kloridnih iona u SIB je određen pomoću opisanog postupaka u opisu pod naslovom Postupak B.
8. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer ima (i) kapacitet vezivanja protona i kapacitet vezivanja klorida najmanje 5 mmol/g u simuliranoj želučanoj tekućini (SGF); i (ii) kapacitet vezivanja kloridnih iona od najmanje 4 mmol/g nakon 1 sata u SIB, pri čemu se SGF sastoji od 35 mM NaCl, 63 mM HCl, pH 1,2, i kapacitet vezivanja protona i kapacitet vezivanja klorida u SGF je određen pomoću postupka opisanog pod naslovom Postupak A, i pufer korišten u SIB testu sadrži 36 mM NaCl, 20 mM NaH2PO4, i 50 mM 2-(N-morfolino)etansulfonske kiseline (MES) čiji pH je puferiran na pH 5,5, i kapacitet vezivanja kloridnih iona u SIB je određen pomoću postupka opisanog u opisu pod naslovom Postupak B.
9. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu, u kojem umreženi aminski polimer je pripremljen postupkom koji obuhvaća umreženi aminski polimer u reakcijskoj smjesi koja sadrži prethodno oblikovani aminski polimer, otapalo, sredstvo za umrežavanje, i agens za bubrenje za prethodno oblikovani aminski polimer, pri čemu agens za bubrenje se poželjno ne miješa s otapalom, prethodno oblikovani aminski polimer ima apsorpcijski kapacitet za agens za bubrenje i količina agensa za bubrenje u reakcijskoj smjesi je manja od apsorcijskog kapaciteta prethodno oblikovanog aminskog polimera za agens za bubrenje.
10. Farmaceutski sastav prema bilo kojem od zahtjeva 1-8, u kojem umreženi aminski polimer je pripremljen postupkom koji obuhvaća dva odvojena koraka polimerizacije/umrežavanja, pri čemu 1) u prvom koraku, oblikuje se prethodno oblikovani aminski polimer koji ima kapacitet vezivanja klorida od najmanje 10 mmol/g u simuliranoj želučanoj tekućini ("SGF") i odnos bubrenja u opsegu 2 do 10, i prethodno oblikovani aminski polimer je (bar djelomično) deprotoniran s bazom i doveden u kontakt sa agensom za bubrenje da nabubri deprotonirani prethodno oblikovani aminski polimer, i 2) u drugom koraku, nabubreni, deprotonirani prethodno oblikovani aminski polimer je umrežen sa sredstvom za umrežavanje koje sadrži aminski reaktivni dio da bi se oblikovao umreženi aminski polimer.
11. Farmaceutski sastav prema bilo kojem od zahteva 1-10, u kojem prethodno oblikovani aminski polimer je umreženi aminski polimer koji sadrži ostatak amina koji odgovara formuli 2: [image] gdje m i n su nezavisno nenegativni cijeli brojevi; R10, R20, R30, i R40 su nezavisno vodik, hidrokarbil ili supstituirani hidrokarbil; X1 je [image] X2 je hidrokarbil ili supstituirani hidrokarbil; svaki X11 je nezavisno vodik, hidrokarbil, supstituirani hidrokarbil, hidroksil, amino, boronska kiselina ili halo i z je nenegativan broj.
12. Farmaceutski sastav prema bilo kojem od zahtjeva 1-10, u kojem prethodno oblikovani aminski polimer je umreženi aminski polimer koji sadrži ostatak amina koji odgovara formuli 2b i umreženi aminski polimer je pripremljen radikalnom polimerizacijom amina koji odgovara formuli 2b: [image] pri čemu m i n su nezavisno nenegativni cijeli brojevi; svaki R12 je nezavisno vodik, supstituirani hidrokarbil, ili hidrokarbil; R22 i R32 su nezavisno vodik, supstituirani hidrokarbil, ili hidrokarbil; R42 je vodik, hidrokarbil ili supstituirani hidrokarbil; X1 je [image] X2 je alkil, aminoalkil, ili alkanol; svaki X13 je nezavisno vodik, hidroksi, alicikličan, amino, aminoalkil, halogen, alkil, heteroaril, boronska kiselina ili aril; z je nenegativni broj, i amin koji odgovara formuli 2b sadrži najmanje jednu alil grupu.
13. Farmaceutski sastav prema zahtjevu 12, u kojem umrežani aminski polimer je pripremljen radikalnom polimerizacijom amina koja odgovara formuli 2b, i m i z su nezavisno 0, 1, 2 ili 3, i n je 0 ili 1.
14. Farmaceutski sastav prema zahtjevu 12, u kojem m je pozitivan cijeli broj, n je pozitivan cijeli broj i R12, R22, R32 i R42, u kombinaciji, sadrže bar dva alil ili vinil dijela.
15. Farmaceutski sastav prema zahtjevu 12, u kojem polimer opisan formulom 2b je sintetiziran iz amina i agenasa za umrežavanje, ili njihovih soli, izabranih 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.
16. Farmaceutski sastav prema bilo kojem od zahtjeva 1-15 u kojem umreženi aminski polimer je umrežen sa agensom za umrežavanja koji može biti korišten u reakcijama supstitucionirane polimerizacije i reakcijama postpolimerizacijskog umrežavanja, pri čemu agens za umrežavanja 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, epihalohidrina kao što su epihlorohidrin 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 glikol diglicidil etar, dietilen glikol diglicidil etar, 1,4-bis(glicidiloksi)benzen, rezorcinol digilcidil etar, 1,6-heksandiol diglicidil etar, trimetilolpropan diglicidil etar, 1,4-cikloheksandimetanol diglicidil etar, 1,3-bis-(2,3-epoksipropiloksi)-2-(2,3-dihidroksipropiloksi)propan, diglicidil estra 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-ilmetil)-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-hromen-2-karboksilat, bis[4-(2,3-epoksi-propiltio)fenil]-sulfid, 1,3-bis(3-glicidoksipropil) tetrametildisiloksan, 9,9-bis[4-(glicidiloksi)fenil]fluorin, triepoksiizocijanurat, glicerol triglicidil etar, N,N-diglicidil-4-glicidiloksianilin, (S,S,S)-triglicidil estar izocijanurične kiseline, (R,R,R)-triglicidil estar izocijanurične kiseline, 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- heptaciklopentiltriciklo [7,3,3,15, 11]heptasiloksan, 4,4 ’metilen bis(N,N-diglicidilanilin), bis(halometil)benzen, bis(halometil)bifenil, bis(halometil)naftalen, toluen diizocijanat, akrilol hlorid, 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.
17. Farmaceutski sastav prema bilo kojem od zahtjeva 9-15, u kojem agens za umrežavanje je agens za umrežavanja izabran između: bis(3-kloropropil)amina, 1,3-dikloro-2-propanola, 1,2-dikloroetana, 1,3-dikloropropana, 1-kloro-2,3-epoksipropana, tris[(2-oksiranil)metil]amina, 3-kloro-1-(3-kloropropilamino)-2-propanola, ili 1,2-bis(3-kloropropilamino)etana.
18. Farmaceutski sastav prema bilo kojem od zahtjeva 9-15, u kojem je agens za umrežavanje dikloroalkan.
19. Farmaceutski sastav prema bilo kojem od zahtjeva 9-15, u kojem je agens za umrežavanje dikloroetan ili dikloropropan.
20. Farmaceutski sastav prema bilo kojem prethodnom zahtjevu za upotrebu u postupku liječenja metaboličke acidoze uklanjanjem HCl pomoću oralnog davanja spomenutog farmaceutskog sastava .
HRP20210204TT 2014-12-10 2021-02-05 Polimeri koji povezuju protone za oralnu primjenu HRP20210204T1 (hr)

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