GEP20094576B - New cyrstalline form iii of agomelatine, a process for its preparation and pharmaceutical compositions containing it - Google Patents

New cyrstalline form iii of agomelatine, a process for its preparation and pharmaceutical compositions containing it

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Publication number
GEP20094576B
GEP20094576B GEAP20069558A GEAP2006009558A GEP20094576B GE P20094576 B GEP20094576 B GE P20094576B GE AP20069558 A GEAP20069558 A GE AP20069558A GE AP2006009558 A GEAP2006009558 A GE AP2006009558A GE P20094576 B GEP20094576 B GE P20094576B
Authority
GE
Georgia
Prior art keywords
pharmaceutical compositions
compositions containing
agomelatine
form iii
preparation
Prior art date
Application number
GEAP20069558A
Inventor
Jean-Claude Souvie
Julie Linol
Gerard Coquerel
Original Assignee
Servier Lab
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 Servier Lab filed Critical Servier Lab
Publication of GEP20094576B publication Critical patent/GEP20094576B/en

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    • 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
    • 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2602/00—Systems containing two condensed rings
    • C07C2602/02—Systems containing two condensed rings the rings having only two atoms in common
    • C07C2602/04—One of the condensed rings being a six-membered aromatic ring
    • C07C2602/10—One of the condensed rings being a six-membered aromatic ring the other ring being six-membered, e.g. tetraline

Abstract

Crystalline form III of the compound of the formula: which is characterized with powder X-ray diffraction diagram, method for its production and pharmaceutical compositions containing them.
GEAP20069558A 2005-08-03 2006-08-02 New cyrstalline form iii of agomelatine, a process for its preparation and pharmaceutical compositions containing it GEP20094576B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR0508276A FR2889521B1 (en) 2005-08-03 2005-08-03 NOVEL CRYSTALLINE FORM III OF AGOMELATIN, PROCESS FOR PREPARING THE SAME AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME

Publications (1)

Publication Number Publication Date
GEP20094576B true GEP20094576B (en) 2009-01-12

Family

ID=36587257

Family Applications (1)

Application Number Title Priority Date Filing Date
GEAP20069558A GEP20094576B (en) 2005-08-03 2006-08-02 New cyrstalline form iii of agomelatine, a process for its preparation and pharmaceutical compositions containing it

Country Status (36)

Country Link
EP (3) EP2210872B1 (en)
JP (1) JP4580370B2 (en)
CN (1) CN100450995C (en)
AR (1) AR057713A1 (en)
AU (1) AU2006203336B2 (en)
BR (1) BRPI0603074A (en)
CA (1) CA2555117A1 (en)
CY (1) CY1118637T1 (en)
DK (1) DK2210872T3 (en)
EA (1) EA011031B1 (en)
ES (1) ES2614934T3 (en)
FR (1) FR2889521B1 (en)
GE (1) GEP20094576B (en)
GT (1) GT200600347A (en)
HK (1) HK1098130A1 (en)
HR (1) HRP20170095T1 (en)
HU (1) HUE030506T2 (en)
JO (1) JO3360B1 (en)
LT (1) LT2210872T (en)
MA (1) MA28449B1 (en)
ME (1) ME02689B (en)
MX (1) MXPA06008790A (en)
MY (1) MY142856A (en)
NO (1) NO337010B1 (en)
NZ (1) NZ548862A (en)
PE (1) PE20070213A1 (en)
PL (1) PL2210872T3 (en)
PT (1) PT2210872T (en)
RS (1) RS55499B1 (en)
SA (1) SA06270253B1 (en)
SG (1) SG130112A1 (en)
SI (1) SI2210872T1 (en)
TW (1) TWI389873B (en)
UA (1) UA83719C2 (en)
WO (1) WO2007015003A2 (en)
ZA (1) ZA200606454B (en)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2934856B1 (en) * 2008-08-05 2010-08-13 Servier Lab NEW PROCESS FOR OBTAINING THE V-CRYSTALLINE FORM OF AGOMELATIN
CN101585779B (en) * 2009-03-10 2014-04-02 上海医药工业研究院 New crystal form of Agomelatine, preparation method and use thereof
WO2011006387A1 (en) * 2009-07-11 2011-01-20 浙江华海药业股份有限公司 Process for preparing agomelatine, crystals of agomelatine and preparing process thereof
CN102001959B (en) * 2009-09-01 2014-07-02 北京本草天源药物研究院 Medicinal crystal as well as preparation method and application thereof
CN102050755B (en) * 2009-10-29 2014-11-05 重庆医药工业研究院有限责任公司 Novel agomelatine crystal forms and preparation methods of agomelatine crystal forms
CN101709036B (en) * 2009-12-17 2012-07-04 天津药物研究院 Preparation of agomelatine midbody, 2-(7-anisyl-1-naphthyl) ethylamine
CN101781226B (en) 2009-12-23 2012-03-28 天津泰普药品科技发展有限公司 Agomelatine and medicine composition thereof
CN101774937B (en) * 2010-02-05 2014-01-08 天津市汉康医药生物技术有限公司 N-[2-(7-methoxyl-1-naphthyl)ethyl]acetamide and compound thereof
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
CZ303787B6 (en) * 2011-01-21 2013-05-02 Zentiva, K.S. Agomelatine metastable crystal forms and pharmaceutical composition thereof
CN102690209A (en) * 2011-03-23 2012-09-26 上海医药工业研究院 Mixed crystal of agomelatine (form-VIII), preparation method and application thereof and pharmaceutical composition containing the same
CN102690210A (en) * 2011-03-23 2012-09-26 上海医药工业研究院 Novel crystal form VII of agomelatine, preparation method and application thereof and pharmaceutical composition containing the same
FR2978916B1 (en) 2011-08-10 2013-07-26 Servier Lab SOLID PHARMACEUTICAL COMPOSITION FOR BUCCAL ADMINISTRATION OF AGOMELATIN
ES2634243T3 (en) 2011-11-30 2017-09-27 Ratiopharm Gmbh Agomelatine-urea complex and crystalline forms thereof
CZ2012108A3 (en) 2012-02-15 2013-02-27 Zentiva Ks A method for the manufacture of a polymorphously stable pharmaceutical composition containing agomelatine
WO2014096373A1 (en) 2012-12-21 2014-06-26 Laboratorios Lesvi, S. L. Process for prepararing n-(2-(7-methoxy-1-naphthalenyl)ethyl) acetamide and solid forms thereof
FR3001894A1 (en) 2013-02-08 2014-08-15 Servier Lab SOLID PHARMACEUTICAL COMPOSITION FOR BUCCAL ADMINISTRATION OF AGOMELATIN
PT2810656T (en) 2013-06-06 2017-11-13 Zentiva As Agomelatine formulations comprising agomelatine in the form of co-crystals
EP2810647A1 (en) 2013-06-06 2014-12-10 Zentiva, a.s. Pharmaceutical formulations comprising agomelatine in the form of agomelatine co-crystal with an organic acid
CZ2013621A3 (en) 2013-08-13 2015-02-25 Zentiva, K.S. Agomelatine thermodynamically stable congealed solution for use in pharmaceutical formulation
WO2015124496A1 (en) 2014-02-19 2015-08-27 Synthon B.V. Pharmaceutical composition comprising amorphous agomelatine
PL3075724T3 (en) 2015-03-31 2023-12-27 F.I.S.- Fabbrica Italiana Sintetici S.P.A. Solid form of agomelatine

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2658818B1 (en) * 1990-02-27 1993-12-31 Adir Cie NOVEL DERIVATIVES WITH NAPHTHALENIC STRUCTURE, PROCESS FOR THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.
FR2866336B1 (en) * 2004-02-13 2006-03-24 Servier Lab NOVEL PROCESS FOR THE SYNTHESIS OF (7-METHOXY-3,4-DIHYDRO-1-NAPHTHALENYL) ACETONITRILE AND APPLICATION TO THE SYNTHESIS OF AGOMELATIN
FR2866335B1 (en) * 2004-02-13 2006-05-26 Servier Lab NEW PROCESS FOR THE SYNTHESIS OF AGOMELATIN

Also Published As

Publication number Publication date
EP2210872B1 (en) 2016-11-16
JO3360B1 (en) 2019-03-13
TWI389873B (en) 2013-03-21
CA2555117A1 (en) 2007-02-03
CN100450995C (en) 2009-01-14
UA83719C2 (en) 2008-08-11
EP1752445A1 (en) 2007-02-14
AR057713A1 (en) 2007-12-12
EP2210872A1 (en) 2010-07-28
ZA200606454B (en) 2007-12-27
DK2210872T3 (en) 2017-02-20
JP2007051140A (en) 2007-03-01
MXPA06008790A (en) 2008-02-04
SA06270253B1 (en) 2011-05-14
SI2210872T1 (en) 2017-03-31
HRP20170095T1 (en) 2017-03-24
SG130112A1 (en) 2007-03-20
ME02689B (en) 2017-10-20
CY1118637T1 (en) 2017-07-12
AU2006203336B2 (en) 2012-07-12
AU2006203336A1 (en) 2007-02-22
EA011031B1 (en) 2008-12-30
NO337010B1 (en) 2015-12-21
PT2210872T (en) 2016-12-01
MA28449B1 (en) 2007-03-01
EP2008993A1 (en) 2008-12-31
LT2210872T (en) 2017-01-10
WO2007015003A3 (en) 2007-04-05
FR2889521B1 (en) 2007-12-28
ES2614934T3 (en) 2017-06-02
NZ548862A (en) 2008-03-28
PE20070213A1 (en) 2007-05-06
RS55499B1 (en) 2017-05-31
FR2889521A1 (en) 2007-02-09
TW200736197A (en) 2007-10-01
WO2007015003A2 (en) 2007-02-08
HK1098130A1 (en) 2007-07-13
MY142856A (en) 2011-01-14
CN1907959A (en) 2007-02-07
EA200601274A1 (en) 2007-02-27
JP4580370B2 (en) 2010-11-10
NO20063516L (en) 2007-02-05
BRPI0603074A (en) 2007-08-14
PL2210872T3 (en) 2017-07-31
HUE030506T2 (en) 2017-05-29
GT200600347A (en) 2007-02-28

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