HRP20200037T4 - TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL - Google Patents

TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL Download PDF

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Publication number
HRP20200037T4
HRP20200037T4 HRP20200037TT HRP20200037T HRP20200037T4 HR P20200037 T4 HRP20200037 T4 HR P20200037T4 HR P20200037T T HRP20200037T T HR P20200037TT HR P20200037 T HRP20200037 T HR P20200037T HR P20200037 T4 HRP20200037 T4 HR P20200037T4
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weight
tablet
disintegrant
lubricant
binder
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HRP20200037TT
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English (en)
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Yoshiharu Inoue
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Otsuka Pharmaceutical Co., Ltd.
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Application filed by Otsuka Pharmaceutical Co., Ltd. filed Critical Otsuka Pharmaceutical Co., Ltd.
Publication of HRP20200037T1 publication Critical patent/HRP20200037T1/hr
Publication of HRP20200037T4 publication Critical patent/HRP20200037T4/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Supply Of Fluid Materials To The Packaging Location (AREA)
  • Basic Packing Technique (AREA)

Claims (7)

1. Tableta koja sadrži 7- [4- (4-benzo [b] tiofen-4-il-piperazin-1-il) butoksi] -1H-kinolin-2-on ili njegovu sol kao aktivni sastojak, pomoćnu tvar (a), vezivo (b), sredstvo za razgradnju (c) i mazivo (d), naznačena time što je pomoćna tvar (a) barem jedan član izabran iz skupine koja se sastoji od laktoze, kukuruznog škroba i mikrokristalne celuloze; vezivo (b) je hidroksipropil celuloza; sredstvo za razgradnju (c) je barem jedan član izabran iz skupine koja se sastoji od nisko supstituirane hidroksipropil celuloze, kroskarmeloza natrija i natrijevog karboksimetil škroba; i mazivo (d) je magnezijev stearat: tableta koja dodatno sadrži premazni sloj na svojoj površini, pri čemu navedeni premazni sloj sadrži bojilo (e), a bojilo (e) sadrži željezov oksid.
2. Tableta u skladu sa zahtjevom 1, koja sadrži: 0.05 do 25% težine 7- [4- (4-benzo [b] tiofen-4-il-piperazin-l-il) butoksi] -lH-kinolin-2-ona ili njegove soli; 10 do 98.5% težine pomoćne tvari (a); 0.1 do 20% težine veziva (b); 1 do 25% težine sredstva za razgradnju (c); i 0.1 do 10% težine maziva (d), u odnosu na težinu obložene tablete prije nanošenja premaza.
3. Tableta u skladu sa zahtjevom 1 ili 2, naznačena time što na 1 težinski dio 7- [4- (4-benzo [b] tiofen-4-il-piperazin-1-il) butoksi] -1H-kinolin-2-on ili njegove soli, tableta sadrži: 1 do 2000 težinskih dijelova pomoćne tvari (a); 0.01 do 100 težinskih dijelova veziva (b); 0.1 do 500 težinskih dijelova sredstva za razgradnju (c); i 0.01 do 50 težinskih dijelova maziva (d).
4. Tableta u skladu sa zahtjevom 4, naznačena time što tableta sadrži 0.1 do 50% težine boje (e) u odnosu na težinu zaštitnog sloja.
5. Tableta u skladu s bilo kojim od zahtjeva 1 do 5, dobivena formiranjem, u tabletu, granulirane tvari dobivene mokrom granulacijom.
6. Tableta prema bilo kojem od zahtjeva 1 do 5, naznačena time što tableta ne sadrži povidon ili krospovidon.
7. Postupak za proizvodnju tableta, postupak uključuje korake: (1) granulacija smjese koja sadrži 7- [4- (4-benzo [b] tiofen-4-il-piperazin-l-il) butoksi] -lH-kinolin-2-on ili njegovu sol, pomoćnu tvar (a), vezivo (b) i sredstvo za razgradnju (c), te daljnjim postupkom umiješano mazivo (d); (2) oblikovanje dobivene smjese u tabletu, i (3) miješanje sredstva za premazivanje, bojila (e) i tekućeg medija za dobivanje smjese za premazivanje, te premazivanje površine tablete smjesom za premazivanje, naznačen time što je pomoćni sastojak (a) barem jedan član izabran iz skupine koja se sastoji od laktoze, kukuruznog škroba i mikrokristalne celuloze; vezivo (b) je hidroksipropil celuloza; sredstvo za razgradnju (c) je barem jedan član izabran iz skupine koja se sastoji od nisko supstituirane hidroksipropil celuloze, kroskarmeloza natrija i natrijevog karboksimetil škroba; i mazivo (d) je magnezijev stearat; i gdje mješavina za premaz sadrži željezov oksid kao bojilo (e).
HRP20200037TT 2011-10-14 2012-10-12 TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL HRP20200037T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2011227057 2011-10-14
EP12840025.6A EP2767285B2 (en) 2011-10-14 2012-10-12 TABLET COMPRISING 7-[4-(4-BENZO[b]THIOPHEN-4-YL-PIPERAZIN-1-YL) BUTOXY]-1H-QUINOLIN-2-ONE OR A SALT THEREOF
PCT/JP2012/076415 WO2013054872A1 (ja) 2011-10-14 2012-10-12 7-[4-(4-ベンゾ[b]チオフェン-4-イル-ピペラジン-1-イル)ブトキシ]-1H-キノリン-2-オン又はその塩を含む錠剤

Publications (2)

Publication Number Publication Date
HRP20200037T1 HRP20200037T1 (hr) 2020-03-20
HRP20200037T4 true HRP20200037T4 (hr) 2025-05-23

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ID=48081918

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HRP20200037TT HRP20200037T4 (hr) 2011-10-14 2012-10-12 TABLETA KOJA SADRŽI 7-[4- (4-BENZO [b] TIOFEN-4-YL-PIPERAZIN-1-YL) BUTOKSI]-1H-KINOLIN-2-ON ILI NJEGOVU SOL

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EP (1) EP2767285B2 (hr)
JP (2) JP6084161B2 (hr)
KR (1) KR102072371B1 (hr)
CN (2) CN103889425B (hr)
AP (1) AP2014007564A0 (hr)
AR (1) AR088319A1 (hr)
AU (1) AU2012321723C1 (hr)
BR (1) BR112014008603A2 (hr)
CA (1) CA2851588C (hr)
CL (1) CL2014000909A1 (hr)
CO (1) CO6950480A2 (hr)
CY (1) CY1122460T1 (hr)
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EA (1) EA032930B1 (hr)
ES (1) ES2762479T5 (hr)
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UA (1) UA114411C2 (hr)
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US20210023078A1 (en) 2021-01-28
US20220331311A1 (en) 2022-10-20
TW201318651A (zh) 2013-05-16
CN103889425B (zh) 2018-08-03
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US20240277703A1 (en) 2024-08-22
US10307419B2 (en) 2019-06-04
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MX2014004135A (es) 2014-07-24
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US20180008600A1 (en) 2018-01-11
AP2014007564A0 (en) 2014-04-30
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SI2767285T1 (sl) 2020-03-31
SG10201608412SA (en) 2016-12-29
CO6950480A2 (es) 2014-05-20
US20190240215A1 (en) 2019-08-08
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CN107397730A (zh) 2017-11-28
EA032930B1 (ru) 2019-08-30
AU2012321723A1 (en) 2014-05-15
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MX376092B (es) 2025-03-07
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FI2767285T4 (fi) 2025-05-08
PL2767285T3 (pl) 2020-04-30
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