HRP20210237T1 - Postupak za proizvodnju stabilnih, amorfnih hibridnih nanočestica koje sadrže barem jedan inhibitor proteinske kinaze i barem jedan polimerni sastojak koji stabilizira i tvori matricu - Google Patents

Postupak za proizvodnju stabilnih, amorfnih hibridnih nanočestica koje sadrže barem jedan inhibitor proteinske kinaze i barem jedan polimerni sastojak koji stabilizira i tvori matricu Download PDF

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HRP20210237T1
HRP20210237T1 HRP20210237TT HRP20210237T HRP20210237T1 HR P20210237 T1 HRP20210237 T1 HR P20210237T1 HR P20210237T T HRP20210237T T HR P20210237TT HR P20210237 T HRP20210237 T HR P20210237T HR P20210237 T1 HRP20210237 T1 HR P20210237T1
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matrix
solid dispersion
polyethylene glycol
castor oil
hydrogenated castor
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HRP20210237TT
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Magnus Brisander
Mustafa Demirbüker
Gérald JESSON
Martin Malmsten
Helene Dérand
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Xspray Microparticles Ab
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Priority claimed from PCT/SE2013/050015 external-priority patent/WO2013105894A1/en
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Publication of HRP20210237T1 publication Critical patent/HRP20210237T1/hr

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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
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Claims (12)

1. Postupak proizvodnje stabilnih, amorfnih čestica krute disperzije koje sadrže inhibitor proteinske kinaze odabran od dasatiniba, soli dasatiniba, hidrata dasatiniba, solvata dasatiniba, ili njihove kombinacije, i barem jedan polimerni sastojak koji stabilizira i tvori matricu, pri čemu navedene čestice krute disperzije imaju stupanj amorfnosti 100 %, postupak sadrži a) pružanje prvog mlaza pod tlakom navedenog inhibitora proteinske kinaze otopljenog u otapalu; b) pružanje drugog mlaza antiotapala pod tlakom koji sadrži super- ili subkritični CO2 fluid; pri čemu je navedeni barem jedan polimerni sastojak koji stabilizira i tvori matricu prisutan u ili navedenom prvom ili drugom mlazu; i c) miješanje navedenog prvog i drugog mlaza, i raspršivanje miješanog mlaza na izlazu mlaznice, čime se tvore navedene čestice krute disperzije; nakon čega slijedi prikupljanje navedenih čestica krute disperzije.
2. Postupak prema zahtjevu 1, pri čemu navedeni mlaz antiotapala pod tlakom sadrži subkritični CO2 fluid s tlakom iznad ili ispod 74 bara i temperaturom od -30 ºC do 31 ºC.
3. Postupak prema bilo kojem od zahtjeva 1 ili 2, pri čemu je količina inhibitora proteinske kinaze 10-70 % mase nastalih čestica krute disperzije.
4. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu je navedeni barem jedan polimerni sastojak koji stabilizira i tvori matricu prisutan u navedenom super- ili subkritičnom CO2 fluidu.
5. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu je navedeni polimerni sastojak koji stabilizira i tvori matricu odabran od metil celuloze, hidroksietil celuloze, hidroksipropil celuloze, hidroksipropil metilceluloze, hidroksipropil metilceluloznog acetat sukcinata, hidroksipropil metilceluloznog ftalata, polivinilpirolidona, polivinil acetat ftalata, kopolividona, krospovidona, metakrilne kiseline i etilakrilat kopolimera, metakrilatne kiseline i metil metakrilat kopolimera, polietilen glikola, polivinil kaprolaktam-polivinil acetat-polietilen glikol kopolimera, DL laktid/glikolid kopolimera, poli DL-laktida, celuloznog acetat ftalata, karbomer homopolimera tipa A, karbomer homopolimera tipa B, aminoalkil metakrilat kopolimera i poloksamera.
6. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu je navedeni polimerni sastojak koji stabilizira i tvori matricu odabran od hidroksipropil metilceluloznog ftalata, hidroksipropil celuloze, kopolividona, hidroksipropil metilceluloznog acetat sukcinata, polivinil acetat ftalata, celuloznog acetat ftalata i polivinilpirolidona.
7. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu je solubilizator dodan u čestice krute disperzije dobivene u koraku c.
8. Postupak prema zahtjevu 7, pri čemu je navedeni solubilizator odabran od polivinil kaprolaktam-polivinil acetat-polietilen glikol kopolimera, d-α-tokoferol kiselina polietilen glikol 1000 sukcinata i hidrogeniranog ricinusovog ulja, poput PEG-40 hidrogeniranog ricinusovog ulja ili PEG-35 hidrogeniranog ricinusovog ulja.
9. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu navedene amorfne čestice krute disperzije su naznačene time da daju amorfni uzorak difrakcije X-zraka na prahu.
10. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu navedeno otapalo je organsko otapalo odabrano od DMSO i trifluoretanola (TFE), ili njihove mješavine.
11. Postupak prema bilo kojem od prethodnih zahtjeva, pri čemu navedene čestice nadalje sadrže solubilizator, unutar čestica.
12. Postupak prema zahtjevu 11, pri čemu navedeni solubilizator je polivinil kaprolaktam-polivinil acetat-polietilen glikol kopolimer, d-α-tokoferol kiselina polietilen glikol 1000 sukcinat ili hidrogenirano ricinusovo ulje, poput PEG-40 hidrogeniranog ricinusovog ulja ili PEG-35 hidrogeniranog ricinusovog ulja.
HRP20210237TT 2012-01-13 2021-02-11 Postupak za proizvodnju stabilnih, amorfnih hibridnih nanočestica koje sadrže barem jedan inhibitor proteinske kinaze i barem jedan polimerni sastojak koji stabilizira i tvori matricu HRP20210237T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201261586187P 2012-01-13 2012-01-13
SE1250015 2012-01-13
US201261713120P 2012-10-12 2012-10-12
SE1251160 2012-10-12
PCT/SE2013/050015 WO2013105894A1 (en) 2012-01-13 2013-01-11 A method for producing stable, amorphous hybrid nanoparticles comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix- forming component.
EP13736318.0A EP2802314B1 (en) 2012-01-13 2013-01-11 A method for producing stable, amorphous hybrid nanoparticles comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix- forming component.

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DK (1) DK2802314T3 (hr)
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CA3168667A1 (en) 2020-01-24 2021-07-29 Nanocopoeia, Llc Amorphous solid dispersions of dasatinib and uses thereof
AU2021212258A1 (en) 2020-01-31 2022-09-29 Nanocopoeia, Llc Amorphous nilotinib microparticles and uses thereof
JP7431635B2 (ja) 2020-03-26 2024-02-15 大王製紙株式会社 包装吸収性物品
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