EA201301065A1 - Смешанный кристаллический агомелатин (форма viii), его способ получения и применение и фармацевтическая композиция, содержащая то же самое - Google Patents

Смешанный кристаллический агомелатин (форма viii), его способ получения и применение и фармацевтическая композиция, содержащая то же самое

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Publication number
EA201301065A1
EA201301065A1 EA201301065A EA201301065A EA201301065A1 EA 201301065 A1 EA201301065 A1 EA 201301065A1 EA 201301065 A EA201301065 A EA 201301065A EA 201301065 A EA201301065 A EA 201301065A EA 201301065 A1 EA201301065 A1 EA 201301065A1
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EA
Eurasian Patent Office
Prior art keywords
pharmaceutical composition
crystalline form
agomelatin
obtaining
application
Prior art date
Application number
EA201301065A
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English (en)
Other versions
EA023278B1 (ru
Inventor
Ю Хуан
Цин Лон
Сюйянь Чжу
Ханьбинь Шань
Чжедун Юань
Сюй Ю
Original Assignee
Шанхай Инститьют Оф Фармасьютикл Индастри
Ле Лаборатуар Сервье
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Application filed by Шанхай Инститьют Оф Фармасьютикл Индастри, Ле Лаборатуар Сервье filed Critical Шанхай Инститьют Оф Фармасьютикл Индастри
Publication of EA201301065A1 publication Critical patent/EA201301065A1/ru
Publication of EA023278B1 publication Critical patent/EA023278B1/ru

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C233/00—Carboxylic acid amides
    • C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
    • C07C233/02—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having nitrogen atoms of carboxamide groups bound to hydrogen atoms or to carbon atoms of unsubstituted hydrocarbon radicals
    • C07C233/08—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having nitrogen atoms of carboxamide groups bound to hydrogen atoms or to carbon atoms of unsubstituted hydrocarbon radicals with carbon atoms of carboxamide groups bound to acyclic carbon atoms of a saturated carbon skeleton containing rings
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive 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
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C233/00—Carboxylic acid amides
    • C07C233/01—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
    • C07C233/16—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms
    • C07C233/17—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom
    • C07C233/18—Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a hydrocarbon radical substituted by singly-bound oxygen atoms with the substituted hydrocarbon radical bound to the nitrogen atom of the carboxamide group by an acyclic carbon atom having the carbon atom of the carboxamide group bound to a hydrogen atom or to a carbon atom of an acyclic saturated carbon skeleton
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

Настоящее изобретение обеспечивает смешанную кристаллическую форму VIII агомелатина, его способ получения, применение и фармацевтическую композицию. Указанный смешанный кристалл включает главным образом кристаллическую форму VI агомелатина. Указанная смешанная кристаллическая форма является стабильной и имеет хорошую воспроизводимость. Посредством тестов стабильности было найдено превосходство по сравнению с кристаллической формой VI с точки зрения стабильности. Вследствие этого, кристаллическая форма VIII настоящего изобретения обладает преимуществами в фармацевтическом получении.
EA201301065A 2011-03-23 2012-03-22 Кристаллический агомелатин (форма-viii), способ его получения, применение и содержащая его фармацевтическая композиция EA023278B1 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2011100706340A CN102690209A (zh) 2011-03-23 2011-03-23 阿戈美拉汀的混晶(形式-ⅷ)、其制备方法、应用和包含其的药物组合物
PCT/CN2012/072818 WO2012126386A1 (zh) 2011-03-23 2012-03-22 阿戈美拉汀的混晶(形式-ⅷ)、其制备方法、应用和包含其的药物组合物

Publications (2)

Publication Number Publication Date
EA201301065A1 true EA201301065A1 (ru) 2014-02-28
EA023278B1 EA023278B1 (ru) 2016-05-31

Family

ID=46855965

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201301065A EA023278B1 (ru) 2011-03-23 2012-03-22 Кристаллический агомелатин (форма-viii), способ его получения, применение и содержащая его фармацевтическая композиция

Country Status (30)

Country Link
US (1) US20140088197A1 (ru)
EP (1) EP2690088B1 (ru)
JP (1) JP6203171B2 (ru)
KR (1) KR20130136546A (ru)
CN (2) CN102690209A (ru)
AR (1) AR085915A1 (ru)
AU (1) AU2012231548B2 (ru)
BR (1) BR112013024022A2 (ru)
CA (1) CA2829690C (ru)
CY (1) CY1118751T1 (ru)
DK (1) DK2690088T3 (ru)
EA (1) EA023278B1 (ru)
ES (1) ES2626030T3 (ru)
GE (1) GEP201606567B (ru)
HK (1) HK1193086A1 (ru)
HR (1) HRP20170575T1 (ru)
HU (1) HUE034329T2 (ru)
LT (1) LT2690088T (ru)
MA (1) MA34959B1 (ru)
MD (1) MD4484C1 (ru)
ME (1) ME02731B (ru)
MX (1) MX355551B (ru)
MY (1) MY166444A (ru)
PL (1) PL2690088T3 (ru)
PT (1) PT2690088T (ru)
RS (1) RS55918B1 (ru)
SG (1) SG193305A1 (ru)
SI (1) SI2690088T1 (ru)
WO (1) WO2012126386A1 (ru)
ZA (1) ZA201306761B (ru)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PH12012000132A1 (en) * 2011-06-09 2014-10-20 Servier Lab New co-crystals of agomelatine, a process for their preparation and pharmaceutical compositions containing them
PT3027588T (pt) * 2013-07-29 2020-06-02 Shanghai Inst Pharmaceutical Ind Complexos de agomelatina e ácidos sulfónicos, processos para a sua preparação e composições farmacêuticas que os contêm.
CN104529804A (zh) * 2014-12-11 2015-04-22 连云港金康医药科技有限公司 阿戈美拉汀的新晶型
ES2959460T3 (es) 2015-03-31 2024-02-26 Fis Fabbrica Italiana Sintetici Spa Forma sólida de agomelatina
EP3466923A1 (en) 2017-10-09 2019-04-10 KRKA, d.d., Novo mesto Process for the preparation of agomelatine in crystalline form

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2658818B1 (fr) * 1990-02-27 1993-12-31 Adir Cie Nouveaux derives a structure naphtalenique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent.
FR2866335B1 (fr) * 2004-02-13 2006-05-26 Servier Lab Nouveau procede de synthese de l'agomelatine
US7498466B2 (en) * 2004-02-13 2009-03-03 Les Laboratoires Servier Process for the synthesis and crystalline form of agomelatine
FR2889522B1 (fr) * 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline iv de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
FR2889521B1 (fr) * 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline iii de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
FR2889523B1 (fr) * 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline v de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
FR2923482B1 (fr) * 2007-11-09 2010-01-29 Servier Lab Nouvelle forme cristalline vi de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
CN101585779B (zh) * 2009-03-10 2014-04-02 上海医药工业研究院 阿戈美拉汀的晶型vi及其制备方法和应用
WO2011006387A1 (zh) * 2009-07-11 2011-01-20 浙江华海药业股份有限公司 阿戈美拉汀的制备方法、阿戈美拉汀晶形及其制备方法
CN101723844A (zh) * 2009-11-21 2010-06-09 浙江华海药业股份有限公司 一种阿戈美拉汀晶形b、它的制备方法和包含它的药物组合物
CN101955440B (zh) * 2009-07-17 2014-04-09 江苏万特制药有限公司 一种阿戈美拉汀新晶型及其制备方法
EP2319827A1 (en) * 2009-11-09 2011-05-11 Ratiopharm GmbH Process for the production of polymorph form I of agomelatine
CN101781226B (zh) * 2009-12-23 2012-03-28 天津泰普药品科技发展有限公司 阿戈美拉汀及其药物组合物
CN101792400B (zh) * 2010-03-16 2013-01-30 华东师范大学 一种阿戈美拉汀的合成方法
EP2580183B1 (en) * 2010-06-10 2014-07-23 Gador S.A. New process for the preparation of n-[2-(7-methoxy-1-naphthyl)-ethyl]acetamide
WO2012046253A2 (en) * 2010-10-08 2012-04-12 Msn Laboratories Limited Process for the preparation of n-[2- (7-methoxy-l-naphthyl) ethyl] acetamide and its novel crystalline forms
CN102452952A (zh) * 2010-11-03 2012-05-16 天津药物研究院 一种高纯度的i型阿戈美拉汀晶体制备方法

Also Published As

Publication number Publication date
CN103476743B (zh) 2015-02-25
CY1118751T1 (el) 2017-07-12
EA023278B1 (ru) 2016-05-31
CA2829690C (en) 2016-08-09
EP2690088B1 (en) 2017-02-22
HRP20170575T1 (hr) 2017-06-30
MD20130074A2 (ru) 2014-03-31
HUE034329T2 (en) 2018-02-28
AR085915A1 (es) 2013-11-06
BR112013024022A2 (pt) 2016-12-06
EP2690088A1 (en) 2014-01-29
MA34959B1 (fr) 2014-03-01
MX2013010634A (es) 2013-10-07
PL2690088T3 (pl) 2017-09-29
MY166444A (en) 2018-06-27
JP6203171B2 (ja) 2017-09-27
MD4484B1 (ru) 2017-05-31
DK2690088T3 (en) 2017-06-06
RS55918B1 (sr) 2017-09-29
MD4484C1 (ru) 2017-12-31
ES2626030T3 (es) 2017-07-21
CN102690209A (zh) 2012-09-26
GEP201606567B (en) 2016-11-10
HK1193086A1 (en) 2014-09-12
NZ615714A (en) 2016-03-31
EP2690088A4 (en) 2014-09-17
PT2690088T (pt) 2017-03-20
KR20130136546A (ko) 2013-12-12
CA2829690A1 (en) 2012-09-27
JP2014516921A (ja) 2014-07-17
US20140088197A1 (en) 2014-03-27
SI2690088T1 (sl) 2017-06-30
MX355551B (es) 2018-04-23
SG193305A1 (en) 2013-10-30
ZA201306761B (en) 2014-05-25
WO2012126386A1 (zh) 2012-09-27
ME02731B (me) 2017-10-20
LT2690088T (lt) 2017-04-10
AU2012231548B2 (en) 2015-11-19
AU2012231548A1 (en) 2013-10-03
CN103476743A (zh) 2013-12-25

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