ES2650604T3 - Nueva forma cristalina VII de agomelatina, método de preparación y utilización de la misma, así como composición farmacéutica que la contiene - Google Patents

Nueva forma cristalina VII de agomelatina, método de preparación y utilización de la misma, así como composición farmacéutica que la contiene Download PDF

Info

Publication number
ES2650604T3
ES2650604T3 ES12760538.4T ES12760538T ES2650604T3 ES 2650604 T3 ES2650604 T3 ES 2650604T3 ES 12760538 T ES12760538 T ES 12760538T ES 2650604 T3 ES2650604 T3 ES 2650604T3
Authority
ES
Spain
Prior art keywords
agomelatine
crystalline form
preparation
well
pharmaceutical composition
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.)
Active
Application number
ES12760538.4T
Other languages
English (en)
Inventor
Yu Huang
Ling Tong
Xueyan Zhu
Hanbin Shan
Zhedong Yuan
Xiong Yu
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.)
Shanghai Institute of Pharmaceutical Industry
Laboratoires Servier SAS
Original Assignee
Shanghai Institute of Pharmaceutical Industry
Laboratoires Servier SAS
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=ES2650604(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Shanghai Institute of Pharmaceutical Industry, Laboratoires Servier SAS filed Critical Shanghai Institute of Pharmaceutical Industry
Application granted granted Critical
Publication of ES2650604T3 publication Critical patent/ES2650604T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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

Forma cristalina de agomelatina, teniendo su diagrama de difracción de rayos X los siguientes valores de distancia interplanar cristalina d, ángulo de Bragg 2θ e intensidad relativa: 2θº d (Å) Intensidad relativa (I%) 10,557 8,3725 32,35 13,301 6,6509 11,45 16,145 5,4855 10,60 17,286 5,1258 6,19 17,841 4,9675 100,00 19,359 4,5813 10,83 20,089 4,4164 11,77 23,366 3,8040 29,82 24,944 3,5667 21,60 26,128 3,4078 12,47 incluyendo cristales cuyos ángulos pico de difracción oscilan en 2θ±0,2º de lo arriba indicado.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
imagen8
imagen9
imagen10
imagen11
imagen12
imagen13

Claims (1)

  1. imagen1
    imagen2
    imagen3
ES12760538.4T 2011-03-23 2012-03-22 Nueva forma cristalina VII de agomelatina, método de preparación y utilización de la misma, así como composición farmacéutica que la contiene Active ES2650604T3 (es)

Applications Claiming Priority (3)

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
CN201110070828 2011-03-23
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 (1)

Publication Number Publication Date
ES2650604T3 true ES2650604T3 (es) 2018-01-19

Family

ID=46855966

Family Applications (1)

Application Number Title Priority Date Filing Date
ES12760538.4T Active ES2650604T3 (es) 2011-03-23 2012-03-22 Nueva forma cristalina VII de agomelatina, método de preparación y utilización de la misma, así como composición farmacéutica que la contiene

Country Status (32)

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

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

Family Cites Families (15)

* 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
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
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
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
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
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
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

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
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 (es) 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
MD4391C1 (ro) 2016-08-31
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 (en) 2014-03-31

Similar Documents

Publication Publication Date Title
ES2650604T3 (es) Nueva forma cristalina VII de agomelatina, método de preparación y utilización de la misma, así como composición farmacéutica que la contiene
FI3351539T3 (fi) Kiteinen monohydraattikompleksi 1-syaani-2-(4-syklopropyylibentsyyli)-4-(ß-D-glukopyranos-1-yyli)bentseenistä ja L-proliinista kidevedessä (1:1:1), menetelmät sen valmistamiseksi ja sen käyttö SGLT-estäjänä
AR112227A2 (es) Sal de hemifumarato del ácido 1-(4-{1-[(e)-4-ciclohexil-3-trifluorometil-benciloxi-imino]-etil}-2-etil-bencil)-azetidin-3-carboxílico, y otras formas cristalinas de la misma
AR082804A1 (es) Formas cristalinas de un inhibidor del factor xa
AR088755A1 (es) Formas solidas de un inhibidor de disociacion transtiretina
AR057714A1 (es) Nueva forma cristalina iv de la agomelatina, un procedimiento para su preparacion, y las composiciones farmaceuticas que la contienen
ECSP12012221A (es) Anticuerpos anti-cd40
EA201391313A1 (ru) C4-монометилтритерпеноидные производные и способы их применения
ECSP088859A (es) Nueva forma cristalina vi de la agomelatina, su procedimiento de preparación y las composiciones farmacéuticas que la contienen
CO6450612A2 (es) Compuestos 1-cianoetilheterociclilcarboxamida sustituidos 750
AR077203A1 (es) Forma polimorfica d del acetato de bazedoxifeno, composiciones farmaceuticas que la contienen metodo para prepararla y uso del mismo para tratar enfermedades mediadas por moduladores selectivos de receptores estrogenicos (serms)
UY35492A (es) Compuestos novedosos
AR057713A1 (es) Forma cristalina iii de la agomelatina, un procedimiento para su preparacion, y las composiciones farmaceuticas que la contienen
PE20120989A1 (es) Sales de disacarina, acido difumarico, acido d-1-hidroxi-2-naftoico y monobenzoico del 2-(4-((2-amino-4-metil-6-(pentilamino) pirimidin-5-il) metil) fenil) acetato de 4-(dimetilamino) butilo
CL2009001686A1 (es) Procedimiento de preparacion de agomelatina; y los compuestos intermediarios considerados.
JP2013507508A5 (es)
NI201500096A (es) Compuesto químicos
ECSP12012338A (es) Triazolopiridinas sustituidas
PE20130212A1 (es) Formas polimorficas de st-246 y metodos de preparacion
CR20150456A (es) Sal abexinostate novedosos asociados en forma cristalina, procedimiento de preparación y composiciones farmacéuticas que los contienen
UY32704A (es) Compuestos de 2,3-dihidro-1h-indeno
AR080249A1 (es) Compuestos en calidad de antagonistas de bradiquinina-b1
CY1118746T1 (el) Μεθοδοι συνθεσης και καθαρισμου για ενωσεις φωσφαπλατινης και χρησεις αυτων
EA201600394A1 (ru) Трициклические соединения пиперидина
AR082435A1 (es) Valsartan altamente cristalino