DK3046584T3 - Terapeutiske polymere nanopartikler og fremgangsmåder til fremstilling og anvendelse deraf - Google Patents

Terapeutiske polymere nanopartikler og fremgangsmåder til fremstilling og anvendelse deraf Download PDF

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DK3046584T3
DK3046584T3 DK14772420.7T DK14772420T DK3046584T3 DK 3046584 T3 DK3046584 T3 DK 3046584T3 DK 14772420 T DK14772420 T DK 14772420T DK 3046584 T3 DK3046584 T3 DK 3046584T3
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James Martin Nolan Iii
Eyoung Shin
Young-Ho Song
Greg Troiano
Hong Wang
Marianne Bernice Ashford
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Astrazeneca Ab
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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Claims (24)

1. Terapeutisk nanopartikel, der omfatter 55 til 85 vægtprocent diblok-polymælkesyre-polyethylenglycol- copolymer, hvor den terapeutiske nanopartikel omfatter 10 til 30 vægtprocent polyethylenglycol, 5 til 20 vægtprocent pamoinsyre og 10 til 25 vægtprocent 2—(3—((7—(3—(ethyl (2 — hydroxyethyl) amino)propoxy)quinazolin-4-yl)amino)-lH-pyrazol- 5-yl)-N-(3 — fluorphenyl)acetamid ("AZD1152 hqpa")·
2. Terapeutisk nanopartikel ifølge krav 1, hvor polymælkesyre- polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 15 kDa til 20 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 4 kDa til 6 kDa af polyethylenglycol.
3. Terapeutisk nanopartikel ifølge krav 2, hvor polymælkesyre-polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 16 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 5 kDa af polyethylenglycol.
4. Terapeutisk nanopartikel ifølge et hvilket som helst af kravene 1 til 3, der omfatter 15 til 22 vægtprocent AZD1152 hqpa.
5. Terapeutisk nanopartikel ifølge krav 1, der omfatter 15 til 25 vægtprocent AZD1152 hqpa, 7 til 15 vægtprocent pamoinsyre og en diblok-polymælkesyre-polyethylenglycol- copolymer, hvor den terapeutiske nanopartikel omfatter 10 til 30 vægtprocent polyethylenglycol, og polymælkesyre- polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 16 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 5 kDa af polyethylenglycol.
6. Terapeutisk nanopartikel ifølge krav 1, der omfatter 15 til 22 vægtprocent AZD1152 hqpa, 7 til 10 vægtprocent pamoinsyre og en diblok-polymælkesyre-polyethylenglycol- copolymer, hvor den terapeutiske nanopartikel omfatter 10 til 30 vægtprocent polyethylenglycol, og polymælkesyre- polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 16 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 5 kDa af polyethylenglycol; hvor mindre end 20 % AZD1152 hgpa er frigivet fra nanopartiklen efter 30 timer i PBS og polysorbat20 ved 37 °C.
7. Terapeutisk nanopartikel ifølge krav 1, der omfatter 15 til 22 vægtprocent AZD1152 hqpa, 7 til 10 vægtprocent pamoinsyre og en diblok-polymælkesyre-polyethylenglycol- copolymer, hvor den terapeutiske nanopartikel omfatter 10 til 30 vægtprocent polyethylenglycol, og polymælkesyre- polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 16 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 5 kDa af polyethylenglycol; hvor mindre end 20 % AZD1152 hqpa er frigivet fra nanopartiklen efter 30 timer i PBS og polysorbat20 ved 37 °C, og hvor nanopartiklerne er fremstillet ved hjælp af en fremgangsmåde, der omfatter følgende trin: 1) kombinering af en første organisk fase, der omfatter en 16:5 PLA-PEG-copolymer, AZD1152 hqpa og pamoinsyre i en opløsningsblanding, der omfatter TFA, benzylalkohol, DMSO og ethylacetat, således at benzylalkohol:ethylacetat er til stede i et molforhold på 1:3,6, og pamoinsyren og AZD1152 hqpa tilsættes ved et indledende molforhold mellem pamoinsyre og AZD1152 hqpa på 0,8:1; med en første vandig opløsning, der omfatter en polyoxyethylen (100)-stearylether i vand, DMSO og benzylalkohol, til frembringelse af en anden fase, hvor forholdet mellem den vandige fase og den organiske fase er 5,5:1; 2) emulgering af den anden fase til frembringelse af en grov emulsion; 3) opbevaring af den grove emulsion i et tidsrum, såsom 10 til 15 minutter, passende ved ca. 0 °C, for eksempel ved nedsænkning i et isbad; 4) frembringelse af en nanoemulsion ved anvendelse af en høj trykshomogenisator; 5) eventuelt afventning i et tidsrum på mindst 5 minutter, for eksempel 10 minutter; 6) bratkøling af emulsionsfasen ved 0-5 °C til derved frembringelse af en bratkølet fase, hvor bratkøling af emulsionsfasen omfatter blanding af emulsionsfasen med en anden vandig opløsning, der omfatter en buffer ved pH 6,5, hvor forholdet mellem den anden vandige opløsning og emulsionen er mellem 2:1 og 10:1, såsom 3:1; 7) tilsætning af en vandig opløsning af overfladeaktivt stof til den bratkølede opløsning; 8) opkoncentrering og isolering af de resulterende nanopartikler ved hjælp af filtrering.
8. Terapeutisk nanopartikel ifølge krav 1, der består af 15- 19 vægt-% AZD1152 hqpa, pamoinsyre i et molforhold på 0,76 i forhold til AZD1152 hqpa og en diblok-polymælkesyre- polyethylenglycol-copolymer, hvor polymælkesyre- polyethylenglycol-copolymeren har en talgennemsnitlig molekylvægt på 16 kDa af polymælkesyre og en talgennemsnitlig molekylvægt på 5 kDa af polyethylenglycol.
9. Terapeutisk nanopartikel ifølge krav 3, hvor den terapeutiske nanopartikel frigiver mindre end 20 % AZD1152 hqpa efter 30 timer i phosphatbufferopløsning og polysorbat20 ved 37 °C.
10. Terapeutisk nanopartikel ifølge et hvilket som helst af kravene 1 til 9, der har en hydrodynamisk diameter på 70-140 nm.
11. Farmaceutisk acceptabel sammensætning, der omfatter et antal terapeutiske nanopartikler ifølge et hvilket som helst af kravene 1 til 10 og et eller flere farmaceutisk acceptable excipienser, fortyndingsmidler og/eller bærestoffer.
12. Terapeutisk nanopartikel ifølge et hvilket som helst af kravene 1 til 10 til anvendelse som et medikament.
13. Sammensætning ifølge krav 11 til anvendelse som et medikament.
14. Terapeutisk nanopartikel ifølge et hvilket som helst af kravene 1 til 10 til anvendelse som et medikament til behandling af cancer.
15. Sammensætning ifølge krav 11 til anvendelse som et medikament til behandling af cancer.
16. Terapeutisk nanopartikel til anvendelse som et medikament til behandling af cancer ifølge krav 14, hvor canceren er lungecancer, kolorektal cancer eller en hæmatologisk cancer, såsom akut myeloid leukæmi (AML) eller diffus storcellet B-cellelymfom (DLBCL) .
17. Sammensætning til anvendelse som et medikament til behandling af cancer ifølge krav 15, hvor canceren er lungecancer, kolorektal cancer eller en hæmatologisk cancer, såsom AML eller DLBCL.
18. Kombination, der er egnet til anvendelse til behandling af cancer, der omfatter en farmaceutisk acceptabel sammensætning ifølge krav 11 og et andet antitumormiddel.
19. Kombination ifølge krav 18, hvor det andet antitumormiddel er valgt blandt: a) standardkemoterapiregimer, der indbefatter erstattende eller supplerende mitosehæmmende kemoterapier ved faste tumorer og hæmatologiske cancere, såsom taxaner og vinca-alkaloider; b) terapier, der er målrettet DNA-skaderesponset, herunder midler, der hæmmer reparation af DNA-skade og cellecyklen; og c) immunmedierede terapier, herunder hæmmere af blokering af immun checkpoint, såsom CTLA4-, PD-1- og PDL-l-målrettede terapier.
20. Kit af dele, der omfatter: a) en lyofiliseret farmaceutisk sammensætning, der omfatter nanopartikler ifølge et hvilket som helst af kravene 1 til 10; og b) en brugsanvisning.
21. Fremgangsmåde til fremstilling af en terapeutisk nanopartikel ifølge krav 1, hvilken fremgangsmåde omfatter: 1) kombinering af en første organisk fase, der omfatter en polymer i ethylacetat, AZD1152 hgpa i et TFA/vand/benzylalkohol-opløsningssystem og pamoinsyre i DMSO, med en første vandig opløsning, der omfatter et overfladeaktivt stof, såsom natriumcholat eller polyoxyethylen (100)-stearylether, i vand og benzylalkohol til frembringelse af en anden fase; 2) emulgering af den anden fase til frembringelse af en emulsion; 3) bratkøling af emulsionsfasen ved < 5 °C til derved frembringelse af en bratkølet fase, hvor bratkøling af emulsionsfasen omfatter blanding af emulsionsfasen med en anden vandig opløsning med et pH på mellem 4 og 7; 4) tilsætning af en vandig opløsning af overfladeaktivt stof; 5) opkoncentrering og isolering af de resulterende nanopartikler ved hjælp af filtrering.
22. Fremgangsmåde ifølge krav 21, der omfatter 1) kombinering af en første organisk fase, der omfatter en polymer i ethylacetat, AZD1152 hqpa i et TFA/vand/benzylalkohol-opløsningssystem og pamoinsyre i DMSO, med en første vandig opløsning, der omfatter et overfladeaktivt stof, såsom natriumcholat eller polyoxyethylen (100)-stearylether, i vand, DMSO og benzylalkohol til frembringelse af en anden fase; 2) emulgering af den anden fase til frembringelse af en grov emulsion; 3) opbevaring af den grove emulsion i et tidsrum; 4) frembringelse af en nanoemulsion ved anvendelse af en høj trykshomogenisator; 5) eventuelt afventning i et tidsrum på mindst 5 minutter; 6) bratkøling af emulsionsfasen ved 0-5 °C til derved frembringelse af en bratkølet fase, hvor bratkøling af emulsionsfasen omfatter blanding af emulsionsfasen med en anden vandig opløsning, der omfatter en buffer med et pH på mellem 4 og 7, såsom pH 6,5; 7) tilsætning af en vandig opløsning af overfladeaktivt stof; 8) opkoncentrering og isolering af de resulterende nanopartikler ved hjælp af filtrering.
23. Fremgangsmåde ifølge krav 22, der omfatter: 1) kombinering af en første organisk fase, der omfatter en 16/5 PLA-PEG copolymer, AZD1152 hqpa og pamoinsyre i en opløsningsblanding, der omfatter TFA, benzylalkohol, DMSO og ethylacetat, således at benzylalkohol:ethylacetat er til stede i et molforhold på 1:3,6, med en første vandig opløsning, der omfatter et overfladeaktivt stof, såsom polyoxyethylen (100)-stearylether, i vand, DMSO og benzylalkohol til frembringelse af en anden fase; 2) emulgering af den anden fase til frembringelse af en grov emulsion; 3) opbevaring af den grove emulsion i et tidsrum; 4) frembringelse af en nanoemulsion ved anvendelse af en høj trykshomogenisator; 5) eventuelt afventning i et tidsrum på mindst 5 minutter; 6) bratkøling af emulsionsfasen ved 0-5 °C til derved frembringelse af en bratkølet fase, hvor bratkøling af emulsionsfasen omfatter blanding af emulsionsfasen med en anden vandig opløsning, der omfatter buffer, ved pH 6,5; 7) tilsætning af en vandig opløsning af overfladeaktivt stof som et opløsningsmiddel; 8) opkoncentrering og isolering af de resulterende nanopartikler ved hjælp af filtrering.
24. Fremgangsmåde ifølge krav 23, hvor pamoinsyren og AZD1152 hqpa tilsættes ved et indledende molforhold mellem pamoinsyre og AZD1152 hqpa på 0,8:1.
DK14772420.7T 2013-09-16 2014-09-12 Terapeutiske polymere nanopartikler og fremgangsmåder til fremstilling og anvendelse deraf DK3046584T3 (da)

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