MD4484B1 - Forma cristalină VIII a agomelatinei, procedeu de preparare, utilizarea acesteia şi compoziţie farmaceutică care o conţine - Google Patents

Forma cristalină VIII a agomelatinei, procedeu de preparare, utilizarea acesteia şi compoziţie farmaceutică care o conţine

Info

Publication number
MD4484B1
MD4484B1 MDA20130074A MD20130074A MD4484B1 MD 4484 B1 MD4484 B1 MD 4484B1 MD A20130074 A MDA20130074 A MD A20130074A MD 20130074 A MD20130074 A MD 20130074A MD 4484 B1 MD4484 B1 MD 4484B1
Authority
MD
Moldova
Prior art keywords
preparation
agomelatine
crystalline form
pharmaceutical composition
composition containing
Prior art date
Application number
MDA20130074A
Other languages
English (en)
Russian (ru)
Other versions
MD20130074A2 (ro
MD4484C1 (ro
Inventor
Хуан
Лун
Сюейянь ЧЖУ
Ханьбинь Шань
Чжедун Юань
С Юй
Original Assignee
Hanghai Institute Of Pharmaceutical Industry
Les Laboratoires Servier
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
Application filed by Hanghai Institute Of Pharmaceutical Industry, Les Laboratoires Servier filed Critical Hanghai Institute Of Pharmaceutical Industry
Publication of MD20130074A2 publication Critical patent/MD20130074A2/ro
Publication of MD4484B1 publication Critical patent/MD4484B1/ro
Publication of MD4484C1 publication Critical patent/MD4484C1/ro

Links

Classifications

    • 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

Landscapes

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

Abstract

Invenţia se referă la forma cristalină mixtă VIII a agomelatinei, procedeul de preparare, utilizarea acesteia şi la o compoziţie farmaceutică care o conţine.Această formă cristalină VIII a agomelatinei este stabilă şi posedă o reproductibilitate bună. În urma testelor de stabilitate s-a dovedit că forma dată este superioară formei cristaline VI. Ca urmare a acestui fapt, forma cristalină VIII din prezenta invenţie posedă avantaje în producere. Procedeul de preparare, conform invenţiei, include dizolvarea compusului agomelatinei în acid acetic, la care se adaugă acetat de sodiu, după care la acest amestec al reacţiei se adaugă apă prin picurare şi se agită la o temperatură cuprinsă între 7…13°C pentru a provoca cristalizarea, cristalele fiind apoi separate din soluţie.
MDA20130074A 2011-03-23 2012-03-22 Forma cristalină VIII a agomelatinei, procedeu de preparare, utilizarea acesteia şi compoziţie farmaceutică care o conţine MD4484C1 (ro)

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 (3)

Publication Number Publication Date
MD20130074A2 MD20130074A2 (ro) 2014-03-31
MD4484B1 true MD4484B1 (ro) 2017-05-31
MD4484C1 MD4484C1 (ro) 2017-12-31

Family

ID=46855965

Family Applications (1)

Application Number Title Priority Date Filing Date
MDA20130074A MD4484C1 (ro) 2011-03-23 2012-03-22 Forma cristalină VIII a agomelatinei, procedeu de preparare, utilizarea acesteia şi compoziţie farmaceutică care o conţine

Country Status (30)

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

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
ME03741B (me) * 2013-07-29 2021-04-20 Shanghai Inst Pharmaceutical Ind Konpleksi agomelatina i sulfonskih kisjelina, postupak njihove proizvodnje i proizvodnje farmaceutskih pripravaka koji ih sadržavaju
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
EP3075724B1 (en) 2015-03-31 2023-07-12 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Solid form of agomelatine
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.
US7498466B2 (en) * 2004-02-13 2009-03-03 Les Laboratoires Servier Process for the synthesis and crystalline form of agomelatine
FR2866335B1 (fr) * 2004-02-13 2006-05-26 Servier Lab Nouveau procede de synthese de l'agomelatine
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
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
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
WO2011154140A2 (en) * 2010-06-10 2011-12-15 Gador S.A. New process for the preparation of n-[2-(7-methoxy-1-naphthyl)-ethyl]acetamide and new crystalline form
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
AU2012231548A1 (en) 2013-10-03
CN103476743A (zh) 2013-12-25
HRP20170575T1 (hr) 2017-06-30
DK2690088T3 (en) 2017-06-06
ZA201306761B (en) 2014-05-25
EA201301065A1 (ru) 2014-02-28
EP2690088A4 (en) 2014-09-17
RS55918B1 (sr) 2017-09-29
HUE034329T2 (en) 2018-02-28
SI2690088T1 (sl) 2017-06-30
NZ615714A (en) 2016-03-31
MX2013010634A (es) 2013-10-07
JP6203171B2 (ja) 2017-09-27
EP2690088B1 (en) 2017-02-22
HK1193086A1 (en) 2014-09-12
WO2012126386A1 (zh) 2012-09-27
PT2690088T (pt) 2017-03-20
SG193305A1 (en) 2013-10-30
MD20130074A2 (ro) 2014-03-31
CN102690209A (zh) 2012-09-26
LT2690088T (lt) 2017-04-10
MY166444A (en) 2018-06-27
BR112013024022A2 (pt) 2016-12-06
CA2829690A1 (en) 2012-09-27
JP2014516921A (ja) 2014-07-17
PL2690088T3 (pl) 2017-09-29
EA023278B1 (ru) 2016-05-31
AU2012231548B2 (en) 2015-11-19
ME02731B (me) 2017-10-20
GEP201606567B (en) 2016-11-10
CN103476743B (zh) 2015-02-25
CA2829690C (en) 2016-08-09
MX355551B (es) 2018-04-23
KR20130136546A (ko) 2013-12-12
ES2626030T3 (es) 2017-07-21
CY1118751T1 (el) 2017-07-12
US20140088197A1 (en) 2014-03-27
AR085915A1 (es) 2013-11-06
MD4484C1 (ro) 2017-12-31
EP2690088A1 (en) 2014-01-29
MA34959B1 (fr) 2014-03-01

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Legal Events

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FG4A Patent for invention issued
KA4A Patent for invention lapsed due to non-payment of fees (with right of restoration)
MM4A Patent for invention definitely lapsed due to non-payment of fees