MD4391C1 - Formă cristalină nouă VII a agomelatinei, procedeu de preparare şi utilizarea acesteia, şi compoziţie farmaceutică care o conţine - Google Patents

Formă cristalină nouă VII a agomelatinei, procedeu de preparare şi utilizarea acesteia, şi compoziţie farmaceutică care o conţine

Info

Publication number
MD4391C1
MD4391C1 MDA20130073A MD20130073A MD4391C1 MD 4391 C1 MD4391 C1 MD 4391C1 MD A20130073 A MDA20130073 A MD A20130073A MD 20130073 A MD20130073 A MD 20130073A MD 4391 C1 MD4391 C1 MD 4391C1
Authority
MD
Moldova
Prior art keywords
crystal form
preparation
agomelatine
pharmaceutical composition
composition containing
Prior art date
Application number
MDA20130073A
Other languages
English (en)
Russian (ru)
Other versions
MD4391B1 (ro
MD20130073A2 (ro
Inventor
Хуан
Тун
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46855966&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MD4391(C1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hanghai Institute Of Pharmaceutical Industry, Les Laboratoires Servier filed Critical Hanghai Institute Of Pharmaceutical Industry
Publication of MD20130073A2 publication Critical patent/MD20130073A2/ro
Publication of MD4391B1 publication Critical patent/MD4391B1/ro
Publication of MD4391C1 publication Critical patent/MD4391C1/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
    • C07C233/16—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
    • C07C233/22—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 an acyclic carbon atom of a carbon skeleton containing six-membered aromatic rings
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • 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
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00—Preparation of carboxylic acid amides
    • C07C231/22—Separation; Purification; Stabilisation; Use of additives
    • C07C231/24—Separation; Purification

Abstract

Invenţia se referă la o formă cristalină nouă VII a agomelatinei, la un procedeu de preparare şi aplicarea acesteia, şi la o compoziţie farmaceutică care o conţine.Această formă cristalină nouă asigură o puritate înaltă, o structură cristalină stabilă şi o reproductibilitate bună. În ce priveşte stabilitatea şi puritatea, ea este superioară numeroaselor forme cristaline cunoscute până în prezent. Ca urmare a acestui fapt, forma cristalină VII din prezenta invenţie posedă avantaje în producere. Procedeul de preparare, conform invenţiei, include dizolvarea compuşilor agomelatinei în acid acetic, la care se adaugă acetat, ulterior la acest amestec al reacţiei se adaugă apă prin picurare şi se agită la o temperatură cuprinsă între 17…23°C pentru a provoca cristalizarea, cristalele fiind apoi separate din soluţie.
MDA20130073A 2011-03-23 2012-03-22 Formă cristalină nouă VII a agomelatinei, procedeu de preparare şi utilizarea acesteia, şi compoziţie farmaceutică care o conţine MD4391C1 (ro)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2011100708280A CN102690210A (zh) 2011-03-23 2011-03-23 阿戈美拉汀的新晶型ⅶ、其制备方法、应用和包含其的药物组合物
PCT/CN2012/072816 WO2012126385A1 (zh) 2011-03-23 2012-03-22 阿戈美拉汀的新晶型ⅶ、其制备方法、应用和包含其的药物组合物

Publications (3)

Publication Number Publication Date
MD20130073A2 MD20130073A2 (ro) 2014-03-31
MD4391B1 MD4391B1 (ro) 2016-01-31
MD4391C1 true MD4391C1 (ro) 2016-08-31

Family

ID=46855966

Family Applications (1)

Application Number Title Priority Date Filing Date
MDA20130073A MD4391C1 (ro) 2011-03-23 2012-03-22 Formă cristalină nouă VII a agomelatinei, procedeu de preparare şi utilizarea acesteia, şi compoziţie farmaceutică care o conţine

Country Status (32)

Country Link
US (1) US9527803B2 (ro)
EP (1) EP2690087B1 (ro)
JP (1) JP6203170B2 (ro)
KR (1) KR20130136544A (ro)
CN (2) CN102690210A (ro)
AR (1) AR085543A1 (ro)
AU (1) AU2012231547B2 (ro)
BR (1) BR112013024219A2 (ro)
CA (1) CA2829687C (ro)
CY (1) CY1119625T1 (ro)
DK (1) DK2690087T3 (ro)
EA (1) EA023297B1 (ro)
ES (1) ES2650604T3 (ro)
GE (1) GEP20156386B (ro)
HK (1) HK1193087A1 (ro)
HR (1) HRP20171831T1 (ro)
HU (1) HUE037264T2 (ro)
LT (1) LT2690087T (ro)
MA (1) MA34958B1 (ro)
MD (1) MD4391C1 (ro)
ME (1) ME02921B (ro)
MX (1) MX355552B (ro)
MY (1) MY185235A (ro)
NO (1) NO2690087T3 (ro)
PL (1) PL2690087T3 (ro)
PT (1) PT2690087T (ro)
RS (1) RS56444B1 (ro)
SG (1) SG193300A1 (ro)
SI (1) SI2690087T1 (ro)
UA (1) UA113058C2 (ro)
WO (1) WO2012126385A1 (ro)
ZA (1) ZA201306760B (ro)

Families Citing this family (6)

* 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
JP6595990B2 (ja) * 2013-07-29 2019-10-23 レ ラボラトワール セルヴィエ アゴメラチンとスルホン酸との新規な複合体、これらの製造方法及びこれらを含有する医薬組成物
KR101470794B1 (ko) 2014-06-30 2014-12-08 순천향대학교 산학협력단 아고멜라틴 공결정의 제조 방법 및 이를 포함하는 조성물
EP3075724B1 (en) 2015-03-31 2023-07-12 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Solid form of agomelatine
EP3466413A1 (en) 2017-10-09 2019-04-10 KRKA, d.d., Novo mesto Pharmaceutical composition containing agomelatine and process for the preparation thereof
EP3466923A1 (en) 2017-10-09 2019-04-10 KRKA, d.d., Novo mesto Process for the preparation of agomelatine in crystalline form

Citations (8)

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EP0447285A1 (fr) * 1990-02-27 1991-09-18 Adir Et Compagnie Nouveaux dérivés à structure naphtalénique, leur procédé de préparation et les compositions pharmaceutiques qui les contiennent
CN1680284A (zh) * 2004-02-13 2005-10-12 瑟维尔实验室 阿戈美拉汀的新合成方法、新晶型及其药物组合物
CN1907959A (zh) * 2005-08-03 2007-02-07 瑟维尔实验室 阿戈美拉汀的新晶形ⅲ、它的制备方法和包含它的药物组合物
CN1907957A (zh) * 2005-08-03 2007-02-07 瑟维尔实验室 阿戈美拉汀的新晶形ⅳ、它的制备方法和包含它的药物组合物
CN1907958A (zh) * 2005-08-03 2007-02-07 瑟维尔实验室 阿戈美拉汀的新晶形ⅴ、它的制备方法和包含它的药物组合物
CN101585779A (zh) * 2009-03-10 2009-11-25 上海医药工业研究院 阿戈美拉汀的新晶型ⅵ及其制备方法和应用
CN101781226A (zh) * 2009-12-23 2010-07-21 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
CN101792400A (zh) * 2010-03-16 2010-08-04 华东师范大学 一种阿戈美拉汀的合成方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7498466B2 (en) * 2004-02-13 2009-03-03 Les Laboratoires Servier Process for the synthesis and crystalline form of agomelatine
US7358395B2 (en) * 2005-08-03 2008-04-15 Les Laboratories Servier Crystalline form V of agomelatine, a process for its preparation and pharmaceutical compositions containing it
CN101781225A (zh) * 2009-11-21 2010-07-21 浙江华海药业股份有限公司 一种阿戈美拉汀晶形a制备方法
EP2319827A1 (en) * 2009-11-09 2011-05-11 Ratiopharm GmbH Process for the production of polymorph form I of agomelatine
CN101704763B (zh) 2009-11-25 2012-03-28 天津泰普药品科技发展有限公司 阿戈美拉汀i型晶体的制备方法
CN101921205B (zh) 2010-08-30 2013-11-20 江苏恩华药业股份有限公司 阿戈美拉汀ⅰ晶型的制备方法
CN102452951B (zh) * 2010-10-25 2014-02-19 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

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EP0447285A1 (fr) * 1990-02-27 1991-09-18 Adir Et Compagnie Nouveaux dérivés à structure naphtalénique, leur procédé de préparation et les compositions pharmaceutiques qui les contiennent
CN1680284A (zh) * 2004-02-13 2005-10-12 瑟维尔实验室 阿戈美拉汀的新合成方法、新晶型及其药物组合物
CN1907959A (zh) * 2005-08-03 2007-02-07 瑟维尔实验室 阿戈美拉汀的新晶形ⅲ、它的制备方法和包含它的药物组合物
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CN1907958A (zh) * 2005-08-03 2007-02-07 瑟维尔实验室 阿戈美拉汀的新晶形ⅴ、它的制备方法和包含它的药物组合物
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CN101781226A (zh) * 2009-12-23 2010-07-21 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
CN101792400A (zh) * 2010-03-16 2010-08-04 华东师范大学 一种阿戈美拉汀的合成方法

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Also Published As

Publication number Publication date
CN102690210A (zh) 2012-09-26
RS56444B1 (sr) 2018-01-31
CA2829687C (en) 2016-08-09
WO2012126385A1 (zh) 2012-09-27
ME02921B (me) 2018-10-20
EP2690087A1 (en) 2014-01-29
EP2690087B1 (en) 2017-08-30
AR085543A1 (es) 2013-10-09
UA113058C2 (xx) 2016-12-12
PT2690087T (pt) 2017-10-04
HK1193087A1 (en) 2014-09-12
ZA201306760B (en) 2014-05-28
HRP20171831T1 (hr) 2017-12-29
SI2690087T1 (sl) 2017-12-29
EP2690087A4 (en) 2014-09-17
ES2650604T3 (es) 2018-01-19
MA34958B1 (fr) 2014-03-01
GEP20156386B (en) 2015-10-26
JP6203170B2 (ja) 2017-09-27
JP2014516341A (ja) 2014-07-10
MX2013010702A (es) 2013-10-01
MD4391B1 (ro) 2016-01-31
KR20130136544A (ko) 2013-12-12
CY1119625T1 (el) 2018-04-04
HUE037264T2 (hu) 2018-08-28
NZ615707A (en) 2016-02-26
MY185235A (en) 2021-04-30
MX355552B (es) 2018-04-23
NO2690087T3 (ro) 2018-01-27
AU2012231547B2 (en) 2015-11-19
US20140011883A1 (en) 2014-01-09
CA2829687A1 (en) 2012-09-27
AU2012231547A1 (en) 2013-10-03
US9527803B2 (en) 2016-12-27
EA201301066A1 (ru) 2014-02-28
SG193300A1 (en) 2013-10-30
DK2690087T3 (en) 2017-12-04
EA023297B1 (ru) 2016-05-31
BR112013024219A2 (pt) 2016-12-20
AU2012231547A8 (en) 2013-10-24
CN103476742B (zh) 2015-04-29
PL2690087T3 (pl) 2018-01-31
CN103476742A (zh) 2013-12-25
LT2690087T (lt) 2017-10-25
MD20130073A2 (ro) 2014-03-31

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