HRP20201155T1 - Postupak dobivanja farmaceutskog pripravka koji sadrži derivat kinolina ili njegovu sol - Google Patents

Postupak dobivanja farmaceutskog pripravka koji sadrži derivat kinolina ili njegovu sol Download PDF

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HRP20201155T1
HRP20201155T1 HRP20201155TT HRP20201155T HRP20201155T1 HR P20201155 T1 HRP20201155 T1 HR P20201155T1 HR P20201155T T HRP20201155T T HR P20201155TT HR P20201155 T HRP20201155 T HR P20201155T HR P20201155 T1 HRP20201155 T1 HR P20201155T1
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pharmaceutical preparation
obtaining
weight
preparation according
agent
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HRP20201155TT
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Xinhua Zhang
Yun Lu
Chenyang Wang
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Jiangsu Hengrui Medicine Co., Ltd.
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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
    • A61K31/33—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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Postupak dobivanja farmaceutskog pripravka koji sadrži tri koraka miješanja aktivnog sastojka (R,E)-N-(4-(3-kloro-4-(piridin-2-ilmetoksi)fenilamino)-3-cijano-7-etoksikinolin-6-il)-3-(1-metilpirolidin-2-il)-propenamida, ili njegove farmaceutski prihvatljive soli s pripravkom za ovlaživanje, i granulaciju, pri čemu taj pripravak za ovlaživanje sadrži najmanje jedno organsko otapalo.
2. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, naznačen time što sadrži i korake sušenja granula dobivenih kao rezultat, i zatim njihovo tabletiranje u tablete ili punjenje u kapsule.
3. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, pri čemu pripravak za ovlaživanje također sadrži vodu.
4. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, pri čemu je pripravak za ovlaživanje najmanje jedno organsko otapalo ili mješovito otapalo organskog otapala i vode.
5. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1 ili 4, pri čemu je organsko otapalo etanol ili aceton, poželjno etanol.
6. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1 ili 4, pri čemu je organsko otapalo prisutno u količini od 20-100 tež.%, poželjno 50-95 tež.%, i još poželjnije 50-80 tež.%, u odnosu na ukupnu težinu pripravka za ovlaživanje.
7. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, pri čemu je aktivni sastojak prisutan u količini od 5%-70%, poželjno 10%-50%, i još poželjnije 20-40% težine, u odnosu na ukupnu težinu pripravka.
8. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, pri čemu je farmaceutski prihvatljiva sol, sol maleata, i poželjno sol dimaleata.
9. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, naznačen time što taj farmaceutski pripravak sadrži punilo, pri čemu je to punilo poželjno jedan pripravak ili više od mikrokristalne celuloze, kalcij hidrogen fosfata, manitol, prethodno želatinizirani škrob i laktoza, i punilo je poželjno prisutno u količini od 5-80% težine, u odnosu na ukupnu težinu pripravka.
10. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, naznačen time što farmaceutski pripravak sadrži vezivno sredstvo, pri čemu je vezivno sredstvo preporučljivo jedna ili više od hidroksipropil metil celuloze, hidroksipropil celuloze, natrij karboksimetil celuloze, polivinilpirolidona i metil celuloze, i vezivno sredstvo je poželjno prisutno u količini od 0,5-15% težine, u odnosu na ukupnu težinu pripravka.
11. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, naznačen time što farmaceutski pripravak sadrži sredstvo za razgradnju, pri čemu to sredstvo za razgradnju može biti jedno ili više odabranih iz skupine sastavljene od slabo-supstituirane hidroksipropil celuloze, natrij kroskarmeloze, natrij karboksimetil škroba i umreženog polivinilpirolidona, i sredstvo za razgradnju je poželjno prisutno u količini od 2-20%, poželjno 4-15%, i još poželjnije 6-10% težine, u odnosu na ukupnu težinu pripravka.
12. Postupak dobivanja farmaceutskog pripravka sukladno patentnom zahtjevu 1, naznačen time što farmaceutski pripravak sadrži mazivo, pri čemu je to mazivo poželjno jedna ili više od pripravaka pudera, magnezij stearata, cink stearata, gliceril behenata, natrij lauril sulfata, hidrogeniziranog biljnog ulja i koloidnog silikon dioksida, i mazivo je poželjno prisutno u količini od oko 0,5-5% težine, u odnosu na ukupnu težinu pripravka.
13. Postupak dobivanja farmaceutskog pripravka, koji sadrži korake: miješanja aktivnog sastojka (R,E)-N-(4-(3-kloro-4-(piridin-2-ilmetoksi)fenilamino)-3-cijano-7-etoksihinolin-6-il)-3-(1-metilpirolidin-2-il)-propenamida, ili farmaceutski prihvatljive njegove soli s pripravkom za ovlaživanje, granulaciju, sušenje granula dobivenih kao rezultat, i njihovo tabletiranje u tablete ili punjenje u kapsule, pri čemu je pripravak za ovlaživanje mješovito otapalo etanola i vode, etanol je prisutan u količini od 50-80% težine u odnosu na ukupnu težinu pripravka za ovlaživanje, i taj farmaceutski pripravak nadalje sadrži: 1) 2-20 tež.% sredstva za razgradnju, pri čemu je sredstvo za razgradnju umreženi polivinilpirolidon; 2) 5-80 tež.% punila, pri čemu je punilo jedan ili više odabran iz skupine sastavljene od laktoze i mikrokristalne celuloze; 3) 0,5-15 tež.% vezivnog sredstva, pri čemu je vezivno sredstvo jedno ili više odabran iz skupine sastavljene od polivinilpirolidona, hidroksipropil metil celuloze i hidroksipropil celuloze; i 4) 0,5-5 tež.% maziva, pri čemu je mazivo jedno ili više odabranih iz skupine sastavljene od magnezij stearata i pudera.
14. Farmaceutski pripravak dobiven postupkom sukladno bilo kojem od patentnih zahtjeva 1 do 13.
15. Farmaceutski pripravak sukladno patentnom zahtjevu 14 za upotrebu u liječenju karcinoma, poželjno karcinoma želuca, karcinoma pluća, ili karcinoma dojke.
HRP20201155TT 2016-01-27 2020-07-23 Postupak dobivanja farmaceutskog pripravka koji sadrži derivat kinolina ili njegovu sol HRP20201155T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201610057228 2016-01-27
PCT/CN2017/072156 WO2017129088A1 (zh) 2016-01-27 2017-01-23 一种含有喹啉衍生物或其盐的药物组合物的制备方法
EP17743703.5A EP3378479B1 (en) 2016-01-27 2017-01-23 Method for preparing pharmaceutical composition comprising quinoline derivative or salt thereof

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EP3769764A4 (en) 2018-03-23 2021-11-24 Wuxi Shuangliang Biotechnology Co., Ltd. PHARMACEUTICAL COMPOSITION AND PROCESS FOR PREPARATION AND ITS USES

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KR20180103090A (ko) 2018-09-18
US20190054025A1 (en) 2019-02-21
CN108938586A (zh) 2018-12-07
JP2019503373A (ja) 2019-02-07
HK1243357A1 (zh) 2018-07-13
PT3378479T (pt) 2020-07-20
AU2017211737B2 (en) 2022-04-28
TW201726138A (zh) 2017-08-01
RS60747B1 (sr) 2020-10-30
WO2017129088A1 (zh) 2017-08-03
LT3378479T (lt) 2020-09-10
RU2018128416A (ru) 2020-02-27
JP6937308B2 (ja) 2021-09-22
RU2735807C2 (ru) 2020-11-09
MX2018008862A (es) 2018-09-07
DK3378479T3 (da) 2020-08-03
CY1123149T1 (el) 2021-10-29
HUE050255T2 (hu) 2020-11-30
BR112018014544A2 (pt) 2018-12-11
US10722469B2 (en) 2020-07-28
CN108938586B (zh) 2021-05-14
AU2017211737A1 (en) 2018-08-02
EP3378479A4 (en) 2018-12-19
CA3008701A1 (en) 2017-08-03
CN107405345A (zh) 2017-11-28
SI3378479T1 (sl) 2020-10-30
PL3378479T3 (pl) 2020-11-02
ES2811031T3 (es) 2021-03-10
EP3378479A1 (en) 2018-09-26

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