DK3036218T3 - Co-krystaller af agomelatin og p-toluensulfonsyre, fremgangsmåde til deres fremstilling og lægemiddelsammen-sætninger indeholdende disse - Google Patents

Co-krystaller af agomelatin og p-toluensulfonsyre, fremgangsmåde til deres fremstilling og lægemiddelsammen-sætninger indeholdende disse Download PDF

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Publication number
DK3036218T3
DK3036218T3 DK14749937.0T DK14749937T DK3036218T3 DK 3036218 T3 DK3036218 T3 DK 3036218T3 DK 14749937 T DK14749937 T DK 14749937T DK 3036218 T3 DK3036218 T3 DK 3036218T3
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Prior art keywords
agomelatin
crystals
procedure
manufacturing
toluensulphonic acid
Prior art date
Application number
DK14749937.0T
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English (en)
Inventor
Ying Luo
Philippe Letellier
Michael Lynch
Hanbin Shan
Yuhui Shen
Original Assignee
Servier Lab
Shanghai Inst Pharmaceutical Ind
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Filing date
Publication date
Priority claimed from PCT/CN2013/080472 external-priority patent/WO2015013903A1/en
Priority claimed from FR1360121A external-priority patent/FR3012141B1/fr
Application filed by Servier Lab, Shanghai Inst Pharmaceutical Ind filed Critical Servier Lab
Application granted granted Critical
Publication of DK3036218T3 publication Critical patent/DK3036218T3/da

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    • 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
    • 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
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    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • 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
    • 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
    • A61P37/02Immunomodulators
    • 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
    • A61P9/00Drugs for disorders of the cardiovascular system
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00Preparation of carboxylic acid amides
    • C07C231/22Separation; Purification; Stabilisation; Use of additives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C303/00Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides
    • C07C303/32Preparation of esters or amides of sulfuric acids; Preparation of sulfonic acids or of their esters, halides, anhydrides or amides of salts of sulfonic acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C309/00Sulfonic acids; Halides, esters, or anhydrides thereof
    • C07C309/01Sulfonic acids
    • C07C309/28Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton
    • C07C309/29Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings
    • C07C309/30Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings of six-membered aromatic rings substituted by alkyl groups
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Immunology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Reproductive Health (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK14749937.0T 2013-07-31 2014-07-30 Co-krystaller af agomelatin og p-toluensulfonsyre, fremgangsmåde til deres fremstilling og lægemiddelsammen-sætninger indeholdende disse DK3036218T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/CN2013/080472 WO2015013903A1 (en) 2013-07-31 2013-07-31 NEW AGOMELATINE p-TOLUENESULFONIC ACID CO-CRYSTAL FORMS AND PREPARATION THEREOF
FR1360121A FR3012141B1 (fr) 2013-10-17 2013-10-17 Nouvelles formes de co-cristaux d'agomelatine et d'acide p-toluenesulfonique, leur procede de preparation et les compositions pharmaceutiques qui les contiennent
PCT/FR2014/051972 WO2015015118A2 (fr) 2013-07-31 2014-07-30 NOUVELLES FORMES DE CO-CRISTAUX D'AGOMELATINE ET D'ACIDE p-TOLUENESULFONIQUE, LEUR PROCEDE DE PREPARATION ET LES COMPOSITIONS PHARMACEUTIQUES QUI LES CONTIENNENT

Publications (1)

Publication Number Publication Date
DK3036218T3 true DK3036218T3 (da) 2019-07-15

Family

ID=51300781

Family Applications (1)

Application Number Title Priority Date Filing Date
DK14749937.0T DK3036218T3 (da) 2013-07-31 2014-07-30 Co-krystaller af agomelatin og p-toluensulfonsyre, fremgangsmåde til deres fremstilling og lægemiddelsammen-sætninger indeholdende disse

Country Status (24)

Country Link
US (1) US9663451B2 (da)
EP (1) EP3036218B1 (da)
JP (1) JP6525996B2 (da)
AU (1) AU2014298230C1 (da)
CA (1) CA2918228C (da)
CY (1) CY1122959T1 (da)
DK (1) DK3036218T3 (da)
EA (1) EA031053B1 (da)
ES (1) ES2734562T3 (da)
HK (2) HK1222167A1 (da)
HR (1) HRP20191119T1 (da)
HU (1) HUE044798T2 (da)
LT (1) LT3036218T (da)
ME (1) ME03388B (da)
MX (1) MX369301B (da)
NZ (1) NZ716153A (da)
PL (1) PL3036218T3 (da)
PT (1) PT3036218T (da)
RS (1) RS58778B1 (da)
RU (1) RU2695609C2 (da)
SG (1) SG11201600005VA (da)
SI (1) SI3036218T1 (da)
UA (1) UA117023C2 (da)
WO (1) WO2015015118A2 (da)

Family Cites Families (5)

* 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
CN101481321B (zh) * 2009-02-27 2012-04-18 上海医药工业研究院 阿戈美拉汀卤化氢复合物及其制备方法
EP2517700B1 (en) * 2011-04-28 2013-07-17 Zentiva, k.s. Pharmaceutically acceptable cocrystals of N-[2-(7-methoxy-1-naphthyl]acetamide and methods of their preparation
EP2851363B1 (en) 2012-05-14 2018-01-03 Shanghai Righthand Pharmtech. Co., Ltd. Agomelatine acid radical composite, and preparation method and application thereof
CN102702041B (zh) * 2012-05-14 2013-08-14 上海右手医药科技开发有限公司 阿戈美拉汀苯磺酸类复合物及其制备方法

Also Published As

Publication number Publication date
AU2014298230C1 (en) 2018-11-08
PL3036218T3 (pl) 2019-09-30
RS58778B1 (sr) 2019-06-28
HRP20191119T1 (hr) 2019-10-18
ME03388B (me) 2020-01-20
JP2016525567A (ja) 2016-08-25
HK1223348A1 (zh) 2017-07-28
SG11201600005VA (en) 2016-02-26
RU2695609C2 (ru) 2019-07-24
AU2014298230A1 (en) 2016-02-04
UA117023C2 (uk) 2018-06-11
CA2918228C (fr) 2019-05-07
US20160168077A1 (en) 2016-06-16
MX2016001218A (es) 2016-05-26
PT3036218T (pt) 2019-06-11
WO2015015118A3 (fr) 2015-04-02
HUE044798T2 (hu) 2019-11-28
EA031053B1 (ru) 2018-11-30
CA2918228A1 (fr) 2015-02-05
NZ716153A (en) 2020-08-28
SI3036218T1 (sl) 2019-06-28
LT3036218T (lt) 2019-05-27
EA201600143A1 (ru) 2016-11-30
AU2014298230B2 (en) 2018-07-26
JP6525996B2 (ja) 2019-06-05
CY1122959T1 (el) 2021-10-29
EP3036218B1 (fr) 2019-04-10
EP3036218A2 (fr) 2016-06-29
WO2015015118A2 (fr) 2015-02-05
MX369301B (es) 2019-11-05
ES2734562T3 (es) 2019-12-10
RU2016106954A3 (da) 2018-06-01
RU2016106954A (ru) 2017-09-04
HK1222167A1 (zh) 2017-06-23
US9663451B2 (en) 2017-05-30

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