JP2020523335A - 経口投与用固形製剤 - Google Patents

経口投与用固形製剤 Download PDF

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Publication number
JP2020523335A
JP2020523335A JP2019568138A JP2019568138A JP2020523335A JP 2020523335 A JP2020523335 A JP 2020523335A JP 2019568138 A JP2019568138 A JP 2019568138A JP 2019568138 A JP2019568138 A JP 2019568138A JP 2020523335 A JP2020523335 A JP 2020523335A
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Japan
Prior art keywords
pharmaceutical composition
cariprazine
solid pharmaceutical
composition according
prophylaxis
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Pending
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JP2019568138A
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English (en)
Japanese (ja)
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JP2020523335A5 (enExample
Inventor
コンタ，メリンダ
スバ，エディト
ベアタ ダロッチ，トゥンデ
ベアタ ダロッチ，トゥンデ
マゴス，ゾルタン
ラボス，ラモーナ ラジツキン
ラボス，ラモーナ ラジツキン
Original Assignee
リヒター ゲデオン ニルバーノシャン ミーケデーレスベニュタールシャシャーグ
リヒター ゲデオン ニルバーノシャン ミーケデーレスベニュタールシャシャーグ
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Publication of JP2020523335A publication Critical patent/JP2020523335A/ja
Publication of JP2020523335A5 publication Critical patent/JP2020523335A5/ja
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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
    • A61K9/20—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
    • 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
    • A61K31/495—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K9/20—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
    • 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
    • A61K9/2072—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D295/00—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms
    • C07D295/02—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements
    • C07D295/027—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements containing only one hetero ring
    • C07D295/03—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements containing only one hetero ring with the ring nitrogen atoms directly attached to acyclic carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D295/00—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms
    • C07D295/02—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements
    • C07D295/027—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements containing only one hetero ring
    • C07D295/033—Heterocyclic compounds containing polymethylene-imine rings with at least five ring members, 3-azabicyclo [3.2.2] nonane, piperazine, morpholine or thiomorpholine rings, having only hydrogen atoms directly attached to the ring carbon atoms containing only hydrogen and carbon atoms in addition to the ring hetero elements containing only one hetero ring with the ring nitrogen atoms directly attached to carbocyclic rings

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2019568138A 2017-06-13 2018-06-12 経口投与用固形製剤 Pending JP2020523335A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
HUP1700253 2017-06-13
HUP1700253 HUP1700253A1 (hu) 2017-06-13 2017-06-13 Szilárd orális gyógyszerkészítmények
PCT/IB2018/054227 WO2018229641A1 (en) 2017-06-13 2018-06-12 Solid preparation of cariprazine for oral administration

Publications (2)

Publication Number Publication Date
JP2020523335A true JP2020523335A (ja) 2020-08-06
JP2020523335A5 JP2020523335A5 (enExample) 2021-07-26

Family

ID=89992469

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019568138A Pending JP2020523335A (ja) 2017-06-13 2018-06-12 経口投与用固形製剤

Country Status (20)

Country Link
US (1) US20200222391A1 (enExample)
EP (1) EP3638210A1 (enExample)
JP (1) JP2020523335A (enExample)
KR (1) KR20200016378A (enExample)
CN (1) CN110769815A (enExample)
AR (1) AR112137A1 (enExample)
AU (1) AU2018284138A1 (enExample)
BR (1) BR112019025214A2 (enExample)
CA (1) CA3064694A1 (enExample)
CL (1) CL2019003619A1 (enExample)
CO (1) CO2020000168A2 (enExample)
EA (1) EA202090029A1 (enExample)
HU (1) HUP1700253A1 (enExample)
IL (1) IL271108A (enExample)
MX (1) MX2019015206A (enExample)
PE (1) PE20200334A1 (enExample)
PH (1) PH12019502566A1 (enExample)
TW (1) TW201906608A (enExample)
WO (1) WO2018229641A1 (enExample)
ZA (1) ZA201908454B (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2025508811A (ja) * 2022-02-22 2025-04-10 上海雲晟研新生物科技有限公司 カリプラジン薬用塩及びその結晶形、医薬組成物、製造方法並びに使用

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101612146B1 (ko) 2008-07-16 2016-04-12 리히터 게데온 닐트. 도파민 수용체 리간드를 함유하는 약학적 제형
US11274087B2 (en) 2016-07-08 2022-03-15 Richter Gedeon Nyrt. Industrial process for the preparation of cariprazine
US11547707B2 (en) 2019-04-10 2023-01-10 Richter Gedeon Nyrt. Carbamoyl cyclohexane derivatives for treating autism spectrum disorder
US11344503B2 (en) * 2019-12-13 2022-05-31 Halo Science LLC Cariprazine release formulations
JP7618296B2 (ja) * 2020-08-26 2025-01-21 上海雲晟研新生物科技有限公司 カリプラジン薬用塩及びその結晶形、製造方法及び応用
CN114748428B (zh) * 2020-12-25 2023-05-23 上海京新生物医药有限公司 一种高载药量的盐酸卡利拉嗪长效缓释微球及其制备方法
CN114681406B (zh) * 2020-12-25 2023-10-13 上海京新生物医药有限公司 一种卡利拉嗪长效缓释微球及其制备方法
WO2023175598A1 (en) 2022-03-17 2023-09-21 Mapi Pharma Ltd. Depot systems comprising cariprazine or salts thereof
HU231682B1 (hu) * 2022-08-05 2025-10-28 Richter Gedeon Nyrt. Kariprazin tartalmú szájban diszpergálódó tabletta

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6248618A (ja) * 1985-08-27 1987-03-03 Zeria Shinyaku Kogyo Kk 徐放性製剤およびその製造法
WO2009104739A1 (ja) * 2008-02-21 2009-08-27 田辺三菱製薬株式会社 経口投与用固形製剤

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US5910319A (en) 1997-05-29 1999-06-08 Eli Lilly And Company Fluoxetine enteric pellets and methods for their preparation and use
HU227534B1 (en) 2003-08-04 2011-08-29 Richter Gedeon Nyrt (thio)carbamoyl-cyclohexane derivatives, process for producing them and pharmaceutical compositions containing them
GB0618879D0 (en) 2006-09-26 2006-11-01 Zysis Ltd Pharmaceutical compositions
HUE036004T2 (hu) * 2007-08-03 2018-06-28 Richter Gedeon Nyrt Dopamin receptor ligandumokat tartalmazó gyógyszerkészítmények és kezelési eljárások dopamin receptor ligandumok alkalmazásával
KR101612146B1 (ko) * 2008-07-16 2016-04-12 리히터 게데온 닐트. 도파민 수용체 리간드를 함유하는 약학적 제형
EA201691582A1 (ru) * 2014-02-07 2017-01-30 Оспекс Фармасьютикалз, Инк. Новые фармацевтические препараты
CN106692149A (zh) * 2015-11-13 2017-05-24 天津市汉康医药生物技术有限公司 一种卡利拉嗪药物口服制剂及其制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6248618A (ja) * 1985-08-27 1987-03-03 Zeria Shinyaku Kogyo Kk 徐放性製剤およびその製造法
WO2009104739A1 (ja) * 2008-02-21 2009-08-27 田辺三菱製薬株式会社 経口投与用固形製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CURRENT PHARMACEUTICAL DESIGN, vol. 22(33), JPN6022011879, 2016, pages 5144 - 5162, ISSN: 0004907616 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2025508811A (ja) * 2022-02-22 2025-04-10 上海雲晟研新生物科技有限公司 カリプラジン薬用塩及びその結晶形、医薬組成物、製造方法並びに使用

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Publication number Publication date
HUP1700253A1 (hu) 2019-01-28
EP3638210A1 (en) 2020-04-22
CL2019003619A1 (es) 2020-05-15
EA202090029A1 (ru) 2020-03-26
AU2018284138A1 (en) 2020-01-16
KR20200016378A (ko) 2020-02-14
MX2019015206A (es) 2020-02-10
ZA201908454B (en) 2021-10-27
US20200222391A1 (en) 2020-07-16
IL271108A (en) 2020-01-30
BR112019025214A2 (pt) 2020-06-16
CN110769815A (zh) 2020-02-07
TW201906608A (zh) 2019-02-16
PH12019502566A1 (en) 2020-07-20
WO2018229641A1 (en) 2018-12-20
PE20200334A1 (es) 2020-02-14
CO2020000168A2 (es) 2021-06-21
AR112137A1 (es) 2019-09-25
CA3064694A1 (en) 2018-12-20

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