CN104363912A - 注射剂 - Google Patents

注射剂 Download PDF

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Publication number
CN104363912A
CN104363912A CN201380021612.2A CN201380021612A CN104363912A CN 104363912 A CN104363912 A CN 104363912A CN 201380021612 A CN201380021612 A CN 201380021612A CN 104363912 A CN104363912 A CN 104363912A
Authority
CN
China
Prior art keywords
injection
compound
salt
base
benzo
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201380021612.2A
Other languages
English (en)
Chinese (zh)
Inventor
佐藤哲也
箕轮卓也
星加裕亮
丰福秀一
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.)
Otsuka Pharmaceutical Co Ltd
Original Assignee
Otsuka Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49483139&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN104363912(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Priority to CN201710701596.1A priority Critical patent/CN107536802A/zh
Priority to CN201911077087.1A priority patent/CN110638752A/zh
Priority to CN202010921162.4A priority patent/CN111888329A/zh
Publication of CN104363912A publication Critical patent/CN104363912A/zh
Pending legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (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)
CN201380021612.2A 2012-04-23 2013-04-23 注射剂 Pending CN104363912A (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CN201710701596.1A CN107536802A (zh) 2012-04-23 2013-04-23 注射剂
CN201911077087.1A CN110638752A (zh) 2012-04-23 2013-04-23 注射剂
CN202010921162.4A CN111888329A (zh) 2012-04-23 2013-04-23 注射剂

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

Related Child Applications (3)

Application Number Title Priority Date Filing Date
CN202010921162.4A Division CN111888329A (zh) 2012-04-23 2013-04-23 注射剂
CN201710701596.1A Division CN107536802A (zh) 2012-04-23 2013-04-23 注射剂
CN201911077087.1A Division CN110638752A (zh) 2012-04-23 2013-04-23 注射剂

Publications (1)

Publication Number Publication Date
CN104363912A true CN104363912A (zh) 2015-02-18

Family

ID=49483139

Family Applications (4)

Application Number Title Priority Date Filing Date
CN201380021612.2A Pending CN104363912A (zh) 2012-04-23 2013-04-23 注射剂
CN202010921162.4A Pending CN111888329A (zh) 2012-04-23 2013-04-23 注射剂
CN201911077087.1A Pending CN110638752A (zh) 2012-04-23 2013-04-23 注射剂
CN201710701596.1A Pending CN107536802A (zh) 2012-04-23 2013-04-23 注射剂

Family Applications After (3)

Application Number Title Priority Date Filing Date
CN202010921162.4A Pending CN111888329A (zh) 2012-04-23 2013-04-23 注射剂
CN201911077087.1A Pending CN110638752A (zh) 2012-04-23 2013-04-23 注射剂
CN201710701596.1A Pending CN107536802A (zh) 2012-04-23 2013-04-23 注射剂

Country Status (31)

Country Link
US (6) US20150086632A1 (https=)
EP (1) EP2868318B2 (https=)
JP (1) JP6249944B2 (https=)
KR (1) KR102168263B1 (https=)
CN (4) CN104363912A (https=)
AR (1) AR090775A1 (https=)
AU (1) AU2013253518B2 (https=)
BR (1) BR112014026398B1 (https=)
CA (1) CA2871398C (https=)
CO (1) CO7151499A2 (https=)
CY (1) CY1123195T1 (https=)
DK (1) DK2868318T4 (https=)
EA (1) EA026124B1 (https=)
ES (1) ES2727454T5 (https=)
HR (1) HRP20190841T4 (https=)
HU (1) HUE043686T2 (https=)
IL (1) IL235211A0 (https=)
IN (1) IN2014DN08870A (https=)
JO (1) JO3524B1 (https=)
LT (1) LT2868318T (https=)
MX (1) MX361722B (https=)
MY (1) MY169099A (https=)
NZ (1) NZ630255A (https=)
PH (1) PH12014502366A1 (https=)
PL (1) PL2868318T5 (https=)
PT (1) PT2868318T (https=)
SG (2) SG10201608684QA (https=)
SI (1) SI2868318T2 (https=)
TW (1) TWI641395B (https=)
UA (1) UA118084C2 (https=)
WO (1) WO2013161830A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN112402421A (zh) * 2012-10-25 2021-02-26 大塚制药株式会社 含有依匹唑派或其盐的预防和/或治疗剂
WO2017106641A1 (en) * 2015-12-17 2017-06-22 Assia Chemical Industries Ltd. Solid state forms of brexpiprazole
EP3411370A1 (en) * 2016-02-01 2018-12-12 Hexal AG Anhydrate-free polymorphically pure micronized crystalline brexpiprazole dihydrate 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
US20200093821A1 (en) * 2016-08-16 2020-03-26 Hexal Ag Pharmaceutical Compositions of a Benzothiophene Compound
WO2018141886A1 (en) * 2017-02-02 2018-08-09 Hexal Aktiengesellschaft Crystalline brexpiprazole
CN113645954B (zh) * 2019-03-28 2024-03-29 大塚制药株式会社 含有苯并氮杂卓化合物的冻干组合物
JPWO2021029020A1 (https=) * 2019-08-13 2021-02-18
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

Citations (3)

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Publication number Priority date Publication date Assignee Title
EP1312356A1 (en) * 2000-08-25 2003-05-21 Senju Pharmaceutical Co., Ltd. Aqueous suspension preparations
CN101528229A (zh) * 2006-10-26 2009-09-09 大塚制药株式会社 含有瑞巴派特的药物水悬浮液及其制备方法
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

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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
WO1998051281A1 (en) 1997-05-14 1998-11-19 Senju Pharmaceutical Co., Ltd. Aqueous suspension preparations with excellent redispersibility
US6656505B2 (en) * 2000-07-21 2003-12-02 Alpharma Uspd Inc. Method for forming an aqueous flocculated suspension
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
US20050032811A1 (en) * 2003-08-06 2005-02-10 Josiah Brown Methods for administering aripiprazole
UA82561C2 (uk) * 2003-10-23 2008-04-25 Оцука Фармасьютикалз Ко., Лтд. Стерильна ін'єкційна композиція арипіпразолу з контрольованим вивільненням, спосіб її виготовлення та спосіб лікування шизофренії
JP4315393B2 (ja) 2005-04-14 2009-08-19 大塚製薬株式会社 複素環化合物
TWI320783B (en) * 2005-04-14 2010-02-21 Otsuka Pharma Co Ltd Heterocyclic compound
CA2622758A1 (en) * 2005-09-15 2007-03-29 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
SI2170279T1 (en) * 2007-07-31 2018-04-30 Otsuka Pharmaceutical Co., Ltd. Methods for producing aripiprazole suspension and freeze-dried formulation
JP5581227B2 (ja) * 2008-03-11 2014-08-27 アルコン リサーチ， リミテッド 硝子体内注射のための低粘度、高凝集トリアムシノロンアセトニド懸濁剤
JP5685193B2 (ja) * 2008-11-19 2015-03-18 メリアル リミテッド セフチオフルおよびケトプロフェンとまたはセフチオフルとベンジルアルコールとを含む製剤
EP2629775A4 (en) * 2010-10-18 2014-06-11 Dainippon Sumitomo Pharma Co INJECTABLE FORMULATION WITH DELAYED RELEASE
HUE065359T2 (hu) * 2011-03-18 2024-05-28 Alkermes Pharma Ireland Ltd Szorbitán-észtereket tartalmazó gyógyászati készítmények
JP2012232958A (ja) 2011-05-09 2012-11-29 Otsuka Pharmaceut Co Ltd 注射製剤
ES2950418T3 (es) * 2012-03-19 2023-10-09 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden alcohol bencílico
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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1312356A1 (en) * 2000-08-25 2003-05-21 Senju Pharmaceutical Co., Ltd. Aqueous suspension preparations
CN101528229A (zh) * 2006-10-26 2009-09-09 大塚制药株式会社 含有瑞巴派特的药物水悬浮液及其制备方法
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Also Published As

Publication number Publication date
US20240277702A1 (en) 2024-08-22
SI2868318T1 (sl) 2019-06-28
SG10201608684QA (en) 2016-12-29
CA2871398A1 (en) 2013-10-31
MY169099A (en) 2019-02-18
CA2871398C (en) 2021-04-27
JO3524B1 (ar) 2020-07-05
SG11201406775UA (en) 2014-12-30
EP2868318A4 (en) 2015-12-09
CN107536802A (zh) 2018-01-05
NZ630255A (en) 2016-05-27
KR102168263B1 (ko) 2020-10-21
EP2868318A1 (en) 2015-05-06
LT2868318T (lt) 2019-07-25
US20200163960A1 (en) 2020-05-28
PH12014502366B1 (en) 2015-01-12
BR112014026398B1 (pt) 2022-11-29
PL2868318T5 (pl) 2022-06-20
EP2868318B1 (en) 2019-03-06
US10624889B2 (en) 2020-04-21
ES2727454T3 (es) 2019-10-16
US20250241909A1 (en) 2025-07-31
CN110638752A (zh) 2020-01-03
PH12014502366A1 (en) 2015-01-12
AR090775A1 (es) 2014-12-03
CN111888329A (zh) 2020-11-06
HK1205678A1 (en) 2015-12-24
CO7151499A2 (es) 2014-12-29
TWI641395B (zh) 2018-11-21
DK2868318T4 (da) 2022-03-28
ES2727454T5 (es) 2022-05-13
KR20150003336A (ko) 2015-01-08
AU2013253518B2 (en) 2017-10-05
BR112014026398A2 (pt) 2017-06-27
US20150086632A1 (en) 2015-03-26
HRP20190841T1 (hr) 2019-07-26
PT2868318T (pt) 2019-06-07
US20220305007A1 (en) 2022-09-29
IL235211A0 (en) 2014-12-31
HRP20190841T4 (hr) 2022-03-04
MX2014012734A (es) 2015-04-10
UA118084C2 (uk) 2018-11-26
CY1123195T1 (el) 2021-10-29
SI2868318T2 (sl) 2022-04-29
EA026124B1 (ru) 2017-03-31
TW201406401A (zh) 2014-02-16
PL2868318T3 (pl) 2019-09-30
DK2868318T3 (da) 2019-06-03
EA201491937A1 (ru) 2015-03-31
HUE043686T2 (hu) 2019-09-30
IN2014DN08870A (https=) 2015-05-22
EP2868318B2 (en) 2022-01-26
WO2013161830A1 (ja) 2013-10-31
MX361722B (es) 2018-12-14
JPWO2013161830A1 (ja) 2015-12-24
JP6249944B2 (ja) 2017-12-20
US20180092910A1 (en) 2018-04-05
AU2013253518A1 (en) 2014-11-06

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