KR102168263B1 - 주사 제제 - Google Patents

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Publication number
KR102168263B1
KR102168263B1 KR1020147032097A KR20147032097A KR102168263B1 KR 102168263 B1 KR102168263 B1 KR 102168263B1 KR 1020147032097 A KR1020147032097 A KR 1020147032097A KR 20147032097 A KR20147032097 A KR 20147032097A KR 102168263 B1 KR102168263 B1 KR 102168263B1
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South Korea
Prior art keywords
injection formulation
compound
salt
injection
dihydrate
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Korean (ko)
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KR20150003336A (ko
Inventor
데츠야 사토
다쿠야 미노와
유스케 호시카
히데카즈 도요후쿠
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오쓰까 세이야꾸 가부시키가이샤
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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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61P25/24—Antidepressants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020147032097A 2012-04-23 2013-04-23 주사 제제 Active KR102168263B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261636932P 2012-04-23 2012-04-23
US61/636,932 2012-04-23
US201361791896P 2013-03-15 2013-03-15
US61/791,896 2013-03-15
PCT/JP2013/061950 WO2013161830A1 (ja) 2012-04-23 2013-04-23 注射製剤

Publications (2)

Publication Number Publication Date
KR20150003336A KR20150003336A (ko) 2015-01-08
KR102168263B1 true KR102168263B1 (ko) 2020-10-21

Family

ID=49483139

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020147032097A Active KR102168263B1 (ko) 2012-04-23 2013-04-23 주사 제제

Country Status (31)

Country Link
US (6) US20150086632A1 (enExample)
EP (1) EP2868318B2 (enExample)
JP (1) JP6249944B2 (enExample)
KR (1) KR102168263B1 (enExample)
CN (4) CN107536802A (enExample)
AR (1) AR090775A1 (enExample)
AU (1) AU2013253518B2 (enExample)
BR (1) BR112014026398B1 (enExample)
CA (1) CA2871398C (enExample)
CO (1) CO7151499A2 (enExample)
CY (1) CY1123195T1 (enExample)
DK (1) DK2868318T4 (enExample)
EA (1) EA026124B1 (enExample)
ES (1) ES2727454T5 (enExample)
HR (1) HRP20190841T4 (enExample)
HU (1) HUE043686T2 (enExample)
IL (1) IL235211A0 (enExample)
IN (1) IN2014DN08870A (enExample)
JO (1) JO3524B1 (enExample)
LT (1) LT2868318T (enExample)
MX (1) MX361722B (enExample)
MY (1) MY169099A (enExample)
NZ (1) NZ630255A (enExample)
PH (1) PH12014502366A1 (enExample)
PL (1) PL2868318T5 (enExample)
PT (1) PT2868318T (enExample)
SG (2) SG11201406775UA (enExample)
SI (1) SI2868318T2 (enExample)
TW (1) TWI641395B (enExample)
UA (1) UA118084C2 (enExample)
WO (1) WO2013161830A1 (enExample)

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JOP20200109A1 (ar) 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
TWI562991B (en) * 2012-04-23 2016-12-21 Otsuka Pharma Co Ltd Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same
JOP20210047A1 (ar) * 2012-10-25 2017-06-16 Otsuka Pharma Co Ltd عامل وقائي و/أو علاجي للأعراض السلوكية والنفسية المصحوبة بمرض تنكسي عصبي أو الأعراض الإندفاعية المصحوبة بمرض ذهني، يحتوي على بريكسبيرازول أو ملحه
WO2017106641A1 (en) * 2015-12-17 2017-06-22 Assia Chemical Industries Ltd. Solid state forms of brexpiprazole
US10501450B2 (en) 2016-02-01 2019-12-10 Hexal Ag Anhydrate-free polymorphically pure micronized crystalline brexpiprazole di-hydrate for use in intramuscular injectable sustained release formulations
WO2017208251A1 (en) * 2016-05-31 2017-12-07 Cipla Limited A new stable polymorph of brexpiprazole and process for preparation thereof
WO2018033484A1 (en) 2016-08-16 2018-02-22 Hexal Aktiengesellschaft Pharmaceutical compositions of a benzothiophene compound
WO2018141886A1 (en) 2017-02-02 2018-08-09 Hexal Aktiengesellschaft Crystalline brexpiprazole
WO2020196814A1 (en) * 2019-03-28 2020-10-01 Otsuka Pharmaceutical Co., Ltd. Benzoazepine compound-containing freeze-dried composition
WO2021029020A1 (ja) * 2019-08-13 2021-02-18 大塚製薬株式会社 経口医薬組成物
US20240315967A1 (en) 2021-09-07 2024-09-26 Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. Long-acting brexpiprazole preparation for injection and preparation method therefor
CN117214053A (zh) * 2023-10-17 2023-12-12 海南卫康制药(潜山)有限公司 一种注射用头孢呋辛钠肌注混悬液的粒度测定方法

Citations (2)

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WO2005016262A2 (en) * 2003-08-06 2005-02-24 Alkermes Controlled Therapeutics Ii, Inc. Methods for administering aripiprazole
WO2012026562A1 (en) * 2010-08-24 2012-03-01 Otsuka Pharmaceutical Co., Ltd. Suspension and cake composition containing carbostyryl derivative and silicone oil and/or silicone oil derivative

Family Cites Families (20)

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ES2284202T3 (es) 1997-05-14 2007-11-01 Senju Pharmaceutical Co., Ltd. Preparaciones acuosas en suspension con excelente redispersabilidad.
JP3402195B2 (ja) * 1997-05-14 2003-04-28 千寿製薬株式会社 再分散性の良い水性懸濁液剤
US6656505B2 (en) * 2000-07-21 2003-12-02 Alpharma Uspd Inc. Method for forming an aqueous flocculated suspension
JP5000835B2 (ja) * 2000-08-25 2012-08-15 千寿製薬株式会社 水性懸濁液剤
AR033485A1 (es) * 2001-09-25 2003-12-26 Otsuka Pharma Co Ltd Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma
CA2543242C (en) * 2003-10-23 2015-04-14 Otsuka Pharmaceutical Co., Ltd. Controlled release sterile freeze-dried aripiprazole formulation and injectable formulation thereof
TWI320783B (en) * 2005-04-14 2010-02-21 Otsuka Pharma Co Ltd Heterocyclic compound
JP4315393B2 (ja) 2005-04-14 2009-08-19 大塚製薬株式会社 複素環化合物
US20070148100A1 (en) 2005-09-15 2007-06-28 Elan Pharma International, Limited Nanoparticulate aripiprazole formulations
TW200808375A (en) * 2006-05-12 2008-02-16 Otsuka Pharma Co Ltd Hydrogel suspension and manufacturing process thereof
TWI415629B (zh) * 2006-10-26 2013-11-21 Otsuka Pharma Co Ltd 含有瑞巴匹特之水性醫藥懸浮物及其製造方法
MX2010001311A (es) * 2007-07-31 2010-04-21 Otsuka Pharma Co Ltd Metodo para producir una suspensi?n de aripiprazol y formulacion liofilizada.
CA2717605C (en) * 2008-03-11 2012-05-15 Alcon Research Ltd. Low viscosity, highly flocculated triamcinolone acetonide suspensions for intravitreal injection
MX2011005217A (es) * 2008-11-19 2011-06-01 Merial Ltd Formulaciones que comprenden ceftiofur y cetoprofeno o ceftiofur y alcohol bencilico.
EP2629775A4 (en) * 2010-10-18 2014-06-11 Dainippon Sumitomo Pharma Co INJECTABLE FORMULATION WITH DELAYED RELEASE
PL2685979T3 (pl) * 2011-03-18 2017-02-28 Alkermes Pharma Ireland Limited Kompozycje farmaceutyczne do wstrzykiwania zawierające środek nierozpuszczalny w wodzie, środek przeciwpsychotyczny, laurynian sorbitanu i polisorbat 20
JP2012232958A (ja) 2011-05-09 2012-11-29 Otsuka Pharmaceut Co Ltd 注射製剤
CA2867137C (en) * 2012-03-19 2020-12-08 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising aripiprazole prodrugs and benzyl alcohol
TWI562991B (en) * 2012-04-23 2016-12-21 Otsuka Pharma Co Ltd Dihydrate of benzothiophene compound or of a salt thereof, and process for producing the same
JOP20200109A1 (ar) * 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005016262A2 (en) * 2003-08-06 2005-02-24 Alkermes Controlled Therapeutics Ii, Inc. Methods for administering aripiprazole
WO2012026562A1 (en) * 2010-08-24 2012-03-01 Otsuka Pharmaceutical Co., Ltd. Suspension and cake composition containing carbostyryl derivative and silicone oil and/or silicone oil derivative

Also Published As

Publication number Publication date
MX2014012734A (es) 2015-04-10
JPWO2013161830A1 (ja) 2015-12-24
US20240277702A1 (en) 2024-08-22
TWI641395B (zh) 2018-11-21
SI2868318T2 (sl) 2022-04-29
AU2013253518A1 (en) 2014-11-06
HK1205678A1 (en) 2015-12-24
HRP20190841T1 (hr) 2019-07-26
HRP20190841T4 (hr) 2022-03-04
CN104363912A (zh) 2015-02-18
AR090775A1 (es) 2014-12-03
WO2013161830A1 (ja) 2013-10-31
TW201406401A (zh) 2014-02-16
MY169099A (en) 2019-02-18
ES2727454T3 (es) 2019-10-16
EP2868318A1 (en) 2015-05-06
EA201491937A1 (ru) 2015-03-31
PH12014502366B1 (en) 2015-01-12
LT2868318T (lt) 2019-07-25
BR112014026398B1 (pt) 2022-11-29
IL235211A0 (en) 2014-12-31
CO7151499A2 (es) 2014-12-29
EA026124B1 (ru) 2017-03-31
CN110638752A (zh) 2020-01-03
DK2868318T4 (da) 2022-03-28
PL2868318T3 (pl) 2019-09-30
NZ630255A (en) 2016-05-27
EP2868318B1 (en) 2019-03-06
IN2014DN08870A (enExample) 2015-05-22
US20250241909A1 (en) 2025-07-31
US20150086632A1 (en) 2015-03-26
ES2727454T5 (es) 2022-05-13
PH12014502366A1 (en) 2015-01-12
EP2868318B2 (en) 2022-01-26
CN107536802A (zh) 2018-01-05
US20220305007A1 (en) 2022-09-29
JO3524B1 (ar) 2020-07-05
US20180092910A1 (en) 2018-04-05
DK2868318T3 (da) 2019-06-03
HUE043686T2 (hu) 2019-09-30
CA2871398C (en) 2021-04-27
SI2868318T1 (sl) 2019-06-28
US10624889B2 (en) 2020-04-21
KR20150003336A (ko) 2015-01-08
SG11201406775UA (en) 2014-12-30
US20200163960A1 (en) 2020-05-28
EP2868318A4 (en) 2015-12-09
SG10201608684QA (en) 2016-12-29
BR112014026398A2 (pt) 2017-06-27
PL2868318T5 (pl) 2022-06-20
AU2013253518B2 (en) 2017-10-05
PT2868318T (pt) 2019-06-07
UA118084C2 (uk) 2018-11-26
CY1123195T1 (el) 2021-10-29
CN111888329A (zh) 2020-11-06
MX361722B (es) 2018-12-14
CA2871398A1 (en) 2013-10-31
JP6249944B2 (ja) 2017-12-20

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