HRP20230510T1 - Farmaceutski pripravak dasatinib - Google Patents

Farmaceutski pripravak dasatinib Download PDF

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Publication number
HRP20230510T1
HRP20230510T1 HRP20230510TT HRP20230510T HRP20230510T1 HR P20230510 T1 HRP20230510 T1 HR P20230510T1 HR P20230510T T HRP20230510T T HR P20230510TT HR P20230510 T HRP20230510 T HR P20230510T HR P20230510 T1 HRP20230510 T1 HR P20230510T1
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cancer
preparation according
particles
preparation
mass
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HRP20230510TT
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Brisander Magnus
Mustafa DEMIRBÛKER
Gérald JESSON
Martin Malmsten
Helene Dérand
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Xspray Pharma Ab (Publ)
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/33—Heterocyclic compounds
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/33—Heterocyclic compounds
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
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    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
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    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
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    • A61K9/1605—Excipients; Inactive ingredients
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    • A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
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Claims (13)

1. Farmaceutski pripravak koji sadrži: stabilne, amorfne, čvrste disperzijske čestice, pri čemu se čestice sastoje od inhibitora protein-kinaze odabrana iz skupine koja se sastoji od dasatiniba, dasatinib hidrata, dasatinib solvata, soli dasatiniba i njihovih kombinacija te najmanje jedne polimerne komponente za stabilizaciju i formiranje matrice, pri čemu čestice imaju stupanj amorfnosti od 100 % i pri čemu je količina inhibitora protein-kinaze u navedenim česticama od 10 % masenog udjela do 70 % masenog udjela.
2. Pripravak u skladu sa zahtjevom 1, pri čemu je količina inhibitora protein-kinaze u navedenim česticama od 10 % masenog udjela do 50 % masenog udjela ili od 10 % masenog udjela do 40 % masenog udjela ili od 10 % masenog udjela do 30 % masenog udjela.
3. Pripravak u skladu sa zahtjevom 1 ili 2, koji nadalje sadrži najmanje jedan farmaceutski prihvatljiv solubilizator odabran iz skupine koja se sastoji od d-α-tokoferol kiselina polietilenglikol 1000 sukcinata, PEG-40 hidrogeniranog ricinusova ulja, PEG-35 ricinusova ulja, PEG-40 stearata, tvrde masti, polioksilglicerida, PEG-8 kaprilnog/kaprinskog glicerida i poloksamera.
4. Pripravak u skladu sa zahtjevom 3, pri čemu je navedeni solubilizator d-α-tokoferol kiselina polietilenglikol 1000 sukcinat.
5. Pripravak u skladu s bilo kojim od zahtjeva 3 – 4, pri čemu je najmanje jedan farmaceutski prihvatljiv solubilizator fizička smjesa s amorfnim čvrstim disperzijskim česticama.
6. Pripravak u skladu s bilo kojim od zahtjeva 3 – 5, pri čemu je najmanje jedan farmaceutski prihvatljiv solubilizator raspoređen na površinu čestica.
7. Pripravak u skladu s bilo kojim od zahtjeva 1 – 6, pri čemu je najmanje jedna polimerna komponenta za stabilizaciju i formiranje matrice odabrana iz skupine koja se sastoji od metil celuloze, hidroksietil celuloze, hidroksipropil celuloze, hidroksipropil metilceluloze, hidroksipropil metilceluloza sukcinata, hidroksipropil metilceluloza ftalata, polivinilpirolidona, polivinil acetat ftalata, kopolividona, krospovidona, kopolimera metakrilne kiseline i etilakrilata, kopolimera metakrilatne kiseline i metil metakrilata, polietilen glikola, DL laktid/glikolid kopolimera, poli DL-laktida, celuloza acetat ftalata, homopolimera karbomera tipa A, homopolimera karbomera tipa B, aminoalkil metakrilatnih kopolimera i poloksamera.
8. Pripravak u skladu s bilo kojim od zahtjeva 1 – 7, pri čemu je najmanje jedna polimerna komponenta za stabilizaciju i formiranje matrice odabrana iz skupine koja se sastoji od hidroksipropil metilceluloza ftalata, hidroksipropil celuloze, kopolividona, hidroksipropil metilceluloza acetat sukcinata, polivinil acetat ftalata, celuloza acetat ftalata i polivinilpirolidona.
9. Pripravak u skladu s bilo kojim od zahtjeva 1 – 8, pri čemu je najmanje jedna polimerna komponenta za stabilizaciju i formiranje matrice kopolividon.
10. Pripravak u skladu s bilo kojim od zahtjeva 1 – 9 za uporabu u liječenju.
11. Pripravak u skladu s bilo kojim od zahtjeva 1 – 9 za uporabu u liječenju proliferativnih poremećaja.
12. Pripravak za uporabu, u skladu sa zahtjevom 11, pri čemu je navedeni proliferativni poremećaj odabran među neurofibromatozom, tuberoznom sklerozom, hemangiomima i limfangiogenezom, cervikalnim, analnim i oralnim rakom, rakom oka, rakom želuca, rakom debelog crijeva, rakom mokraćnog mjehura, rektalnim rakom, rakom jetre, rakom gušterače, rakom pluća, rakom dojke, rakom vrata maternice, rakom tijela maternice, rakom jajnika, rakom prostate, rakom testisa, rakom bubrega, rakom mozga, rakom središnjeg živčanog sustava, rakom glave i vrata, rakom grla, melanomom kože, akutnom limfocitnom leukemijom, akutnom mijeloičnom leukemijom, Ewingovim sarkomom, Kaposijevim sarkomom, karcinomom bazalnih stanica i karcinomom pločastih stanica, karcinomom malih stanica pluća, koriokarcinomom, rabdomiosarkomom, angiosarkomom, hemangioendoteliomom, Wilmsovim tumorom, neuroblastomom, rakom usta/ždrijela, rakom jednjaka, rakom grkljana, limfomom, multiplim mijelomom; hipertrofijom srca, senilnom makularnom degeneracijom i dijabetičkom retinopatijom.
13. Pripravak za uporabu, u skladu sa zahtjevom 11 ili 12, pri čemu se navedeni pripravak daje uz hranu.
HRP20230510TT 2012-01-13 2013-01-11 Farmaceutski pripravak dasatinib HRP20230510T1 (hr)

Applications Claiming Priority (5)

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
EP17155686.3A EP3181122B1 (en) 2012-01-13 2013-01-11 Dasatinib pharmaceutical composition

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HRP20230510T1 true HRP20230510T1 (hr) 2023-10-27

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HRP20230529TT HRP20230529T1 (hr) 2012-01-13 2013-01-11 Farmaceutski pripravak nilotinib

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US (20) US9456992B2 (hr)
EP (7) EP3766486A1 (hr)
JP (13) JP6238310B2 (hr)
CN (4) CN107115317A (hr)
AU (8) AU2013208323B2 (hr)
CA (2) CA2860932C (hr)
DK (2) DK3181128T3 (hr)
ES (2) ES2946735T3 (hr)
FI (2) FI3181122T3 (hr)
HR (2) HRP20230510T1 (hr)
IL (4) IL293779B2 (hr)
IN (1) IN2014DN06529A (hr)
MX (4) MX347456B (hr)
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