DK2547649T3 - Agomelatinhydrochloridhydrat og fremstilling heraf - Google Patents
Agomelatinhydrochloridhydrat og fremstilling heraf Download PDFInfo
- Publication number
- DK2547649T3 DK2547649T3 DK11755679.5T DK11755679T DK2547649T3 DK 2547649 T3 DK2547649 T3 DK 2547649T3 DK 11755679 T DK11755679 T DK 11755679T DK 2547649 T3 DK2547649 T3 DK 2547649T3
- Authority
- DK
- Denmark
- Prior art keywords
- agomelatine
- hydrochloride hydrate
- preparing
- organic solvent
- disorders
- Prior art date
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
- C07C233/18—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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- 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
- 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
- A61P9/12—Antihypertensives
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C231/00—Preparation of carboxylic acid amides
- C07C231/12—Preparation of carboxylic acid amides by reactions not involving the formation of carboxamide groups
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Epidemiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Psychiatry (AREA)
- Diabetes (AREA)
- Anesthesiology (AREA)
- Obesity (AREA)
- Pain & Pain Management (AREA)
- Hematology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Claims (12)
1. Agomelatinhydrogenchloridhydrat med formel I:
hvor X er Cl.
2. Agomelatinhydrogenchloridhydrat med formel I ifølge krav 1 i form af en krystallinsk form, kendetegnet ved, at følgende Bragg-vinkel 2Θ, interplansaf-stand d og relativ intensitet:
og som også indbefatter krystaller, hvis topdiffraktionsvinkler passer inden for en fejl på ± 0,2°.
3. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 1 eller 2, hvor agomelatin omsættes med HCI i et vandigt organisk opløsningsmiddel for at fremstille agomelatinhydrogenchloridhydratet.
4. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 1 eller 2, hvor agomelatin opløses i et organisk opløsningsmiddel før vandig FICI-opløsning sættes til for at udfælde produktkrystallerne.
5. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 4, hvor nævnte vandige FICI-opløsning tilsættes dråbevis.
6. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 3, hvor agomelatin sættes til et vandigt organisk opløsningsmiddel indeholdende HCI for at udfælde produktkrystallerne.
7. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 4 eller 6, som yderligere indbefatter at rense og tørre det faste stof efter krystallisation.
8. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 4 eller 6, hvor reaktionstemperaturen er 0-20°C.
9. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 4 eller 6, hvor nævnte organiske opløsningsmiddel er ethylacetat, methylacetat, n-butylacetat, acetone eller acetonitril.
10. Fremgangsmåde til fremstilling af agomelatinhydrogenchloridhydratet ifølge krav 9, hvor nævnte organiske opløsningsmiddel er ethylacetat.
11. Farmaceutisk tablet omfattende et agomelatinhydrogenchloridhydrat ifølge krav 1 eller 2 sammen med farmaceutisk acceptable adjuvanser eller excipien-ser.
12. Anvendelse af et agomelatinhydrogenchloridhydrat ifølge krav 1 eller 2 til behandling af melatoninerge systemforstyrrelser, søvnforstyrrelser, stress, ængstelse, sæsonaffektive forstyrrelser, større depression, cardiovaskulære sygdomme, fordøjelsessystemssygdomme, søvnløshed og træthed forårsaget af jetlag, skizofreni, fobier eller depressionsforstyrrelser.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010126254XA CN102190594A (zh) | 2010-03-17 | 2010-03-17 | 阿戈美拉汀氯化氢水合物及其制备方法 |
| PCT/CN2011/071910 WO2011113362A1 (en) | 2010-03-17 | 2011-03-17 | Agomelatine hydrochloride hydrate and preparation thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2547649T3 true DK2547649T3 (da) | 2015-03-02 |
Family
ID=44599556
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11755679.5T DK2547649T3 (da) | 2010-03-17 | 2011-03-17 | Agomelatinhydrochloridhydrat og fremstilling heraf |
Country Status (36)
| Country | Link |
|---|---|
| US (1) | US8729131B2 (da) |
| EP (1) | EP2547649B1 (da) |
| JP (1) | JP5634532B2 (da) |
| KR (1) | KR101406727B1 (da) |
| CN (2) | CN102190594A (da) |
| AP (1) | AP2012006492A0 (da) |
| AU (1) | AU2011229618B2 (da) |
| BR (1) | BR112012023317B1 (da) |
| CA (1) | CA2792417C (da) |
| CL (1) | CL2012002540A1 (da) |
| CR (1) | CR20120462A (da) |
| CU (1) | CU20120137A7 (da) |
| CY (1) | CY1116086T1 (da) |
| DK (1) | DK2547649T3 (da) |
| EA (1) | EA022067B1 (da) |
| EC (1) | ECSP12012155A (da) |
| ES (1) | ES2530772T3 (da) |
| GE (1) | GEP20156231B (da) |
| GT (1) | GT201200259A (da) |
| HK (1) | HK1177451A1 (da) |
| HR (1) | HRP20150071T1 (da) |
| IL (1) | IL221782A (da) |
| MA (1) | MA34055B1 (da) |
| ME (1) | ME02054B (da) |
| MX (1) | MX2012010541A (da) |
| NI (1) | NI201200140A (da) |
| NZ (1) | NZ602450A (da) |
| PE (1) | PE20130013A1 (da) |
| PL (1) | PL2547649T3 (da) |
| PT (1) | PT2547649E (da) |
| RS (1) | RS53815B1 (da) |
| SG (1) | SG183868A1 (da) |
| SI (1) | SI2547649T1 (da) |
| TN (1) | TN2012000435A1 (da) |
| UA (1) | UA105425C2 (da) |
| WO (1) | WO2011113362A1 (da) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2551257A1 (en) * | 2011-07-28 | 2013-01-30 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of agomelatine with co-crystal-formers |
| FR2978916B1 (fr) | 2011-08-10 | 2013-07-26 | Servier Lab | Composition pharmaceutique solide pour administration buccale d'agomelatine |
| 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 |
| US9409857B2 (en) * | 2012-05-14 | 2016-08-09 | Shanghai Righthand Pharmtech, Co., Ltd. | Agomelatine sulfuric acid complex, and preparation method and application thereof |
| CN102718675B (zh) * | 2012-06-07 | 2015-03-25 | 上海右手医药科技开发有限公司 | 阿戈美拉汀甲磺酸复合物及其制备方法 |
| CN102718676B (zh) * | 2012-06-26 | 2014-04-09 | 福建广生堂药业股份有限公司 | 阿戈美拉汀硫酸盐及其制备方法 |
| 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 (fr) | 2013-02-08 | 2014-08-15 | Servier Lab | Composition pharmaceutique solide pour administration buccale d'agomelatine |
| WO2015013865A1 (en) * | 2013-07-29 | 2015-02-05 | Les Laboratoires Servier | Agomelatine sulfonic acids complexes and preparation thereof |
| KR101470794B1 (ko) * | 2014-06-30 | 2014-12-08 | 순천향대학교 산학협력단 | 아고멜라틴 공결정의 제조 방법 및 이를 포함하는 조성물 |
| MY193514A (en) | 2015-07-02 | 2022-10-17 | Acerta Pharma Bv | Solid forms and formulations of (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1, 5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide |
| US10484302B2 (en) * | 2016-08-27 | 2019-11-19 | Nicira, Inc. | Managed forwarding element executing in public cloud data compute node with different internal and external network addresses |
Family Cites Families (7)
| 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. |
| MXPA03003761A (es) * | 2000-10-30 | 2003-07-28 | Teva Pharma | Formas de cristales y solvatos de clorhidrato de ondansetron y procesos para su preparacion. |
| FR2890562B1 (fr) * | 2005-09-09 | 2012-10-12 | Servier Lab | Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement des troubles du sommeil chez le patient deprime |
| FR2899472B1 (fr) * | 2006-04-07 | 2008-09-12 | Servier Lab | Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement du trouble anxiete generalisee |
| FR2934859B1 (fr) | 2008-08-05 | 2010-08-13 | Servier Lab | Nouveau procede de synthese de l'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 |
| WO2012046253A2 (en) * | 2010-10-08 | 2012-04-12 | Msn Laboratories Limited | Process for the preparation of n-[2- (7-methoxy-l-naphthyl) ethyl] acetamide and its novel crystalline forms |
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2010
- 2010-03-17 CN CN201010126254XA patent/CN102190594A/zh active Pending
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2011
- 2011-03-17 NZ NZ602450A patent/NZ602450A/en not_active IP Right Cessation
- 2011-03-17 ME MEP-2015-23A patent/ME02054B/me unknown
- 2011-03-17 PT PT117556795T patent/PT2547649E/pt unknown
- 2011-03-17 EP EP11755679.5A patent/EP2547649B1/en active Active
- 2011-03-17 SI SI201130403T patent/SI2547649T1/sl unknown
- 2011-03-17 CN CN201180024357.8A patent/CN102958911B/zh not_active Expired - Fee Related
- 2011-03-17 US US13/635,063 patent/US8729131B2/en active Active
- 2011-03-17 KR KR1020127026895A patent/KR101406727B1/ko active IP Right Grant
- 2011-03-17 SG SG2012065009A patent/SG183868A1/en unknown
- 2011-03-17 PE PE2012001448A patent/PE20130013A1/es active IP Right Grant
- 2011-03-17 BR BR112012023317-3A patent/BR112012023317B1/pt not_active IP Right Cessation
- 2011-03-17 AU AU2011229618A patent/AU2011229618B2/en not_active Ceased
- 2011-03-17 MX MX2012010541A patent/MX2012010541A/es active IP Right Grant
- 2011-03-17 EA EA201201294A patent/EA022067B1/ru unknown
- 2011-03-17 GE GEAP201112869A patent/GEP20156231B/en unknown
- 2011-03-17 CA CA2792417A patent/CA2792417C/en active Active
- 2011-03-17 ES ES11755679T patent/ES2530772T3/es active Active
- 2011-03-17 DK DK11755679.5T patent/DK2547649T3/da active
- 2011-03-17 JP JP2012557392A patent/JP5634532B2/ja active Active
- 2011-03-17 MA MA35192A patent/MA34055B1/fr unknown
- 2011-03-17 RS RS20150041A patent/RS53815B1/en unknown
- 2011-03-17 PL PL11755679T patent/PL2547649T3/pl unknown
- 2011-03-17 UA UAA201211720A patent/UA105425C2/ru unknown
- 2011-03-17 WO PCT/CN2011/071910 patent/WO2011113362A1/en active Application Filing
- 2011-03-17 AP AP2012006492A patent/AP2012006492A0/xx unknown
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2012
- 2012-08-31 TN TNP2012000435A patent/TN2012000435A1/en unknown
- 2012-09-04 IL IL221782A patent/IL221782A/en not_active IP Right Cessation
- 2012-09-11 CR CR20120462A patent/CR20120462A/es unknown
- 2012-09-12 NI NI201200140A patent/NI201200140A/es unknown
- 2012-09-13 CL CL2012002540A patent/CL2012002540A1/es unknown
- 2012-09-14 EC ECSP12012155 patent/ECSP12012155A/es unknown
- 2012-09-17 GT GT201200259A patent/GT201200259A/es unknown
- 2012-09-17 CU CU2012000137A patent/CU20120137A7/es unknown
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2013
- 2013-04-16 HK HK13104588.5A patent/HK1177451A1/zh not_active IP Right Cessation
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2015
- 2015-01-20 HR HRP20150071AT patent/HRP20150071T1/hr unknown
- 2015-01-22 CY CY20151100071T patent/CY1116086T1/el unknown
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