ZA200606454B - Crystalline form III of agomelatine, a process for its preparation and pharmaceutical compositions containing it - Google Patents

Crystalline form III of agomelatine, a process for its preparation and pharmaceutical compositions containing it

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Publication number
ZA200606454B
ZA200606454B ZA200606454A ZA200606454A ZA200606454B ZA 200606454 B ZA200606454 B ZA 200606454B ZA 200606454 A ZA200606454 A ZA 200606454A ZA 200606454 A ZA200606454 A ZA 200606454A ZA 200606454 B ZA200606454 B ZA 200606454B
Authority
ZA
South Africa
Prior art keywords
agomelatine
preparation
pharmaceutical compositions
crystalline form
compositions containing
Prior art date
Application number
ZA200606454A
Inventor
Coquerel Gurard
Linol Julie
Souvie Jean-Claude
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 ZA200606454B publication Critical patent/ZA200606454B/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00Preparation of carboxylic acid amides
    • C07C231/22Separation; Purification; Stabilisation; Use of additives
    • C07C231/24Separation; Purification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/06Antimigraine agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C233/00Carboxylic acid amides
    • C07C233/01Carboxylic acid amides having carbon atoms of carboxamide groups bound to hydrogen atoms or to acyclic carbon atoms
    • C07C233/16Carboxylic 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
    • C07C233/17Carboxylic 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
    • C07C233/18Carboxylic 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2602/00Systems containing two condensed rings
    • C07C2602/02Systems containing two condensed rings the rings having only two atoms in common
    • C07C2602/04One of the condensed rings being a six-membered aromatic ring
    • C07C2602/10One of the condensed rings being a six-membered aromatic ring the other ring being six-membered, e.g. tetraline

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  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Immunology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Steroid Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ZA200606454A 2005-08-03 2006-08-03 Crystalline form III of agomelatine, a process for its preparation and pharmaceutical compositions containing it ZA200606454B (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
ZA200606454B true ZA200606454B (en) 2007-12-27

Family

ID=36587257

Family Applications (1)

Application Number Title Priority Date Filing Date
ZA200606454A ZA200606454B (en) 2005-08-03 2006-08-03 Crystalline 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
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
CZ303787B6 (en) * 2011-01-21 2013-05-02 Zentiva, K.S. Agomelatine metastable crystal forms and pharmaceutical composition thereof
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
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
FR2978916B1 (en) 2011-08-10 2013-07-26 Servier Lab SOLID PHARMACEUTICAL COMPOSITION FOR BUCCAL ADMINISTRATION OF AGOMELATIN
EP2771312B1 (en) 2011-11-30 2017-05-31 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
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
PT2810656T (en) 2013-06-06 2017-11-13 Zentiva As Agomelatine formulations comprising agomelatine in the form of co-crystals
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
EP3075724B1 (en) 2015-03-31 2023-07-12 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.
FR2866335B1 (en) * 2004-02-13 2006-05-26 Servier Lab NEW PROCESS FOR THE SYNTHESIS OF AGOMELATIN
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

Also Published As

Publication number Publication date
WO2007015003A2 (en) 2007-02-08
SG130112A1 (en) 2007-03-20
PL2210872T3 (en) 2017-07-31
FR2889521A1 (en) 2007-02-09
MXPA06008790A (en) 2008-02-04
TW200736197A (en) 2007-10-01
LT2210872T (en) 2017-01-10
JP4580370B2 (en) 2010-11-10
NZ548862A (en) 2008-03-28
PE20070213A1 (en) 2007-05-06
EP1752445A1 (en) 2007-02-14
EA200601274A1 (en) 2007-02-27
GT200600347A (en) 2007-02-28
MY142856A (en) 2011-01-14
AU2006203336B2 (en) 2012-07-12
HK1098130A1 (en) 2007-07-13
ME02689B (en) 2017-10-20
EP2210872A1 (en) 2010-07-28
AR057713A1 (en) 2007-12-12
JP2007051140A (en) 2007-03-01
PT2210872T (en) 2016-12-01
CN1907959A (en) 2007-02-07
NO337010B1 (en) 2015-12-21
EP2210872B1 (en) 2016-11-16
MA28449B1 (en) 2007-03-01
CA2555117A1 (en) 2007-02-03
JO3360B1 (en) 2019-03-13
HUE030506T2 (en) 2017-05-29
EP2008993A1 (en) 2008-12-31
UA83719C2 (en) 2008-08-11
WO2007015003A3 (en) 2007-04-05
RS55499B1 (en) 2017-05-31
CN100450995C (en) 2009-01-14
HRP20170095T1 (en) 2017-03-24
SI2210872T1 (en) 2017-03-31
DK2210872T3 (en) 2017-02-20
ES2614934T3 (en) 2017-06-02
GEP20094576B (en) 2009-01-12
FR2889521B1 (en) 2007-12-28
EA011031B1 (en) 2008-12-30
SA06270253B1 (en) 2011-05-14
TWI389873B (en) 2013-03-21
NO20063516L (en) 2007-02-05
BRPI0603074A (en) 2007-08-14
AU2006203336A1 (en) 2007-02-22
CY1118637T1 (en) 2017-07-12

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