CN102014909B - 口服用固体制剂 - Google Patents

口服用固体制剂 Download PDF

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Publication number
CN102014909B
CN102014909B CN2009801148592A CN200980114859A CN102014909B CN 102014909 B CN102014909 B CN 102014909B CN 2009801148592 A CN2009801148592 A CN 2009801148592A CN 200980114859 A CN200980114859 A CN 200980114859A CN 102014909 B CN102014909 B CN 102014909B
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China
Prior art keywords
tablet
solid preparation
weight
excipient
starch
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CN2009801148592A
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Chinese (zh)
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CN102014909A (zh
Inventor
大林靖明
大川亚纪子
叶玉敦子
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Richter Gedeon Nyrt
Original Assignee
Mitsubishi Tanabe Pharma Corp
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Publication of CN102014909A publication Critical patent/CN102014909A/zh
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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
    • A61K31/495—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychiatry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN2009801148592A 2008-02-21 2009-02-20 口服用固体制剂 Active CN102014909B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
JP2008040696 2008-02-21
JP2008-040696 2008-02-21
JP2008284685 2008-11-05
JP2008-284685 2008-11-05
PCT/JP2009/053039 WO2009104739A1 (ja) 2008-02-21 2009-02-20 経口投与用固形製剤

Publications (2)

Publication Number Publication Date
CN102014909A CN102014909A (zh) 2011-04-13
CN102014909B true CN102014909B (zh) 2013-03-13

Family

ID=40985616

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2009801148592A Active CN102014909B (zh) 2008-02-21 2009-02-20 口服用固体制剂

Country Status (9)

Country Link
US (1) US20110059980A1 (enExample)
EP (1) EP2251011B1 (enExample)
JP (2) JP4409630B2 (enExample)
KR (2) KR20130115393A (enExample)
CN (1) CN102014909B (enExample)
AT (1) ATE552002T1 (enExample)
CA (1) CA2715760C (enExample)
EA (1) EA023972B1 (enExample)
WO (1) WO2009104739A1 (enExample)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUP0700353A2 (en) * 2007-05-18 2008-12-29 Richter Gedeon Nyrt Metabolites of (thio)carbamoyl-cyclohexane derivatives
US7875610B2 (en) * 2007-12-03 2011-01-25 Richter Gedeon Nyrt. Pyrimidinyl-piperazines useful as D3/D2 receptor ligands
EA023972B1 (ru) * 2008-02-21 2016-08-31 Рихтер Гедеон Нирт. Стабильный твёрдый препарат карипразина для перорального введения и способ его получения
HRP20150196T1 (hr) 2008-07-16 2015-06-05 Richter Gedeon Nyrt. Farmaceutske formulacije s ligandima receptora dopamina
HU230067B1 (hu) 2008-12-17 2015-06-29 Richter Gedeon Nyrt Új piperazin só és eljárás előállítására
HUP0800765A2 (en) 2008-12-18 2010-11-29 Richter Gedeon Nyrt A new process for the preparation of piperazine derivatives and their hydrochloric salts
HUP0800766A2 (en) 2008-12-18 2010-11-29 Richter Gedeon Vegyeszet Process for the preparation of piperazine derivatives
CN106560179B (zh) * 2015-09-30 2020-02-21 石药集团中奇制药技术（石家庄）有限公司 盐酸卡利拉嗪药物组合物及其制备方法
EP3231418A1 (en) * 2016-04-14 2017-10-18 Richter Gedeon Nyrt. Granule formulation for oral administration
KR20190022709A (ko) * 2016-06-28 2019-03-06 가부시키가이샤 니폰 고킨 소고 겐큐쇼 부형제 및 정제
US11274087B2 (en) 2016-07-08 2022-03-15 Richter Gedeon Nyrt. Industrial process for the preparation of cariprazine
CN107970217A (zh) * 2016-10-25 2018-05-01 浙江京新药业股份有限公司 卡利拉嗪口腔崩解片及其制备方法
CN108261394B (zh) * 2017-01-04 2022-03-04 广东东阳光药业有限公司 一种盐酸卡利拉嗪注射制剂及其制备方法和用途
HUP1700253A1 (hu) * 2017-06-13 2019-01-28 Richter Gedeon Nyrt Szilárd orális gyógyszerkészítmények
US11273156B2 (en) * 2018-11-20 2022-03-15 Aurobindo Pharma Ltd Stable cariprazine formulations for oral use
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
JP2023536341A (ja) * 2020-08-06 2023-08-24 エスケー バイオファーマスティカルズ カンパニー リミテッド カルバメート化合物を含む経口用固形製剤及びその製造方法
CN118526462B (zh) * 2024-07-25 2024-11-15 山东则正医药技术有限公司 不同规格溶出行为相似的盐酸卡利拉嗪口崩片及制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1829703A (zh) * 2003-08-04 2006-09-06 匈牙利吉瑞大药厂 作为d3/d2受体拮抗剂的(硫代)氨基甲酰基－环己烷衍生物

Family Cites Families (25)

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US4666911A (en) * 1981-07-14 1987-05-19 Taiho Pharmaceutical Company Limited Allophanoylpiperazine compound and analgesic composition containing same as active ingredient
GB8802622D0 (en) * 1988-02-05 1988-03-02 Glaxo Group Ltd Chemical compound
US4957921A (en) * 1989-12-06 1990-09-18 Warner-Lambert Company Substituted cyclohexanols as central nervous system agents
AU707748B2 (en) * 1994-03-25 1999-07-22 Isotechnika Inc. Enhancement of the efficacy of drugs by deuteration
US6334997B1 (en) * 1994-03-25 2002-01-01 Isotechnika, Inc. Method of using deuterated calcium channel blockers
US6528529B1 (en) * 1998-03-31 2003-03-04 Acadia Pharmaceuticals Inc. Compounds with activity on muscarinic receptors
AU742720B2 (en) * 1998-06-30 2002-01-10 Zeria Pharmaceutical Co., Ltd. N-phenyl-N'-phenylpropylpiperazine derivatives and process for the preparation thereof
US6489341B1 (en) * 1999-06-02 2002-12-03 Sepracor Inc. Methods for the treatment of neuroleptic and related disorders using sertindole derivatives
BR0207832A (pt) * 2001-02-27 2004-06-22 Ortho Mcneil Pharm Inc Compostos de carbamato para uso na prevenção ou tratamento de distúrbio bipolar
US6566550B2 (en) * 2001-06-21 2003-05-20 Pfizer Inc Substituted aromatic ethers as inhibitors of glycine transport
HU227543B1 (en) * 2001-09-28 2011-08-29 Richter Gedeon Nyrt N-[4-(2-piperazin- and 2-piperidin-1-yl-ethyl)-cyclohexyl]-sulfon- and sulfamides, process for their preparation, their use and pharmaceutical compositions containing them
US6919342B2 (en) * 2003-06-05 2005-07-19 Abbott Gmbh & Co. Kg Triazole compounds suitable for treating disorders that respond to modulation of the dopamine D3 receptor
DE102004047517A1 (de) * 2004-09-28 2006-03-30 Merck Patent Gmbh Neuartige Kristallform von (3-Cyan-1H-indol-7-yl)-[4-(4-fluorphenethyl)-piperazin-1-yl]-methanon, Hydrochlorid
PL2155200T3 (pl) * 2007-05-11 2017-06-30 Richter Gedeon Nyrt. Postać krystaliczna pochodnej karbamoilo-cykloheksanu
HU230748B1 (hu) * 2007-05-11 2018-02-28 Richter Gedeon Nyrt Új piperazin só és előállítási eljárása
HUP0700353A2 (en) * 2007-05-18 2008-12-29 Richter Gedeon Nyrt Metabolites of (thio)carbamoyl-cyclohexane derivatives
HUP0700370A2 (en) * 2007-05-24 2009-04-28 Richter Gedeon Nyrt Use of (thio)-carbamoyl-cyclohexane derivatives in the manufacture of a medicament for the treatment of acute mania
HUP0700369A2 (en) * 2007-05-24 2009-04-28 Richter Gedeon Nyrt Use of (thio)-carbamoyl-cyclohexane derivatives in the manufacture of a medicament for the treatment in the manufacture of a medicament for the treatment of schizophrenia
MX2010001171A (es) * 2007-08-01 2010-03-01 Lundbeck & Co As H Uso de abridores de canales de potasio kcnq para reducir los sintomas o tratar desordenes o afecciones en las cuales se encuentra anulado el sistema dopaminergico.
US7875610B2 (en) * 2007-12-03 2011-01-25 Richter Gedeon Nyrt. Pyrimidinyl-piperazines useful as D3/D2 receptor ligands
EA023972B1 (ru) * 2008-02-21 2016-08-31 Рихтер Гедеон Нирт. Стабильный твёрдый препарат карипразина для перорального введения и способ его получения
HRP20150196T1 (hr) * 2008-07-16 2015-06-05 Richter Gedeon Nyrt. Farmaceutske formulacije s ligandima receptora dopamina
HU230067B1 (hu) * 2008-12-17 2015-06-29 Richter Gedeon Nyrt Új piperazin só és eljárás előállítására
HUP0800765A2 (en) * 2008-12-18 2010-11-29 Richter Gedeon Nyrt A new process for the preparation of piperazine derivatives and their hydrochloric salts
HUP0800766A2 (en) * 2008-12-18 2010-11-29 Richter Gedeon Vegyeszet Process for the preparation of piperazine derivatives

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1829703A (zh) * 2003-08-04 2006-09-06 匈牙利吉瑞大药厂 作为d3/d2受体拮抗剂的(硫代)氨基甲酰基－环己烷衍生物

Also Published As

Publication number Publication date
CA2715760C (en) 2017-06-13
KR20100117676A (ko) 2010-11-03
WO2009104739A1 (ja) 2009-08-27
US20110059980A1 (en) 2011-03-10
ATE552002T1 (de) 2012-04-15
EP2251011A4 (en) 2011-03-02
JPWO2009104739A1 (ja) 2011-06-23
CA2715760A1 (en) 2009-08-27
KR20130115393A (ko) 2013-10-21
EA201001334A1 (ru) 2011-06-30
JP2010132654A (ja) 2010-06-17
EP2251011A1 (en) 2010-11-17
EP2251011B1 (en) 2012-04-04
KR101563383B1 (ko) 2015-10-26
JP4409630B2 (ja) 2010-02-03
CN102014909A (zh) 2011-04-13
EA023972B1 (ru) 2016-08-31

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SE01 Entry into force of request for substantive examination
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Effective date of registration: 20180130

Address after: Budapest

Patentee after: Richter Gedeon Nyrt

Address before: Osaka Japan

Patentee before: Mitsubishi Tanabe Pharma Corporation

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