FR2995896B1 - Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent. - Google Patents

Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent.

Info

Publication number
FR2995896B1
FR2995896B1 FR1259064A FR1259064A FR2995896B1 FR 2995896 B1 FR2995896 B1 FR 2995896B1 FR 1259064 A FR1259064 A FR 1259064A FR 1259064 A FR1259064 A FR 1259064A FR 2995896 B1 FR2995896 B1 FR 2995896B1
Authority
FR
France
Prior art keywords
agomelatin
preparation
pharmaceutical compositions
same
compositions containing
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.)
Expired - Fee Related
Application number
FR1259064A
Other languages
English (en)
Other versions
FR2995896A1 (fr
Inventor
David Lafargue
Michael Lynch
Cecile Poirier
Philippe Letellier
Jean-Manuel Pean
Ying Luo
Hanbin Shan
Yuhui Shen
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
Application filed by Shanghai Institute of Pharmaceutical Industry, Laboratoires Servier SAS filed Critical Shanghai Institute of Pharmaceutical Industry
Priority to FR1259064A priority Critical patent/FR2995896B1/fr
Priority to JOP/2013/0247A priority patent/JO3339B1/ar
Priority to UY0001035004A priority patent/UY35004A/es
Priority to TW102131714A priority patent/TWI581811B/zh
Priority to ARP130103199A priority patent/AR092485A1/es
Priority to CN201380046980.2A priority patent/CN104619346A/zh
Priority to ES13762107.4T priority patent/ES2659196T3/es
Priority to EA201500313A priority patent/EA030645B1/ru
Priority to PCT/EP2013/068792 priority patent/WO2014041015A1/fr
Priority to MEP-2018-2A priority patent/ME02988B/fr
Priority to JP2015530452A priority patent/JP6559065B2/ja
Priority to BR112015005303A priority patent/BR112015005303A2/pt
Priority to AU2013314396A priority patent/AU2013314396B2/en
Priority to DK13762107.4T priority patent/DK2895195T3/en
Priority to EP13762107.4A priority patent/EP2895195B1/fr
Priority to NO13762107A priority patent/NO2895195T3/no
Priority to HUE13762107A priority patent/HUE036043T2/hu
Priority to LTEP13762107.4T priority patent/LT2895195T/lt
Priority to PL13762107T priority patent/PL2895195T3/pl
Priority to MYPI2015700555A priority patent/MY181682A/en
Priority to US14/426,853 priority patent/US20150238614A1/en
Priority to SI201330888T priority patent/SI2895195T1/en
Priority to UAA201503239A priority patent/UA116994C2/uk
Priority to NZ705802A priority patent/NZ705802A/en
Priority to CN201910934869.6A priority patent/CN110639021A/zh
Priority to MX2015003015A priority patent/MX358995B/es
Priority to GEAP201313784A priority patent/GEP20186881B/en
Priority to SG11201501333TA priority patent/SG11201501333TA/en
Priority to CA2882927A priority patent/CA2882927C/fr
Priority to KR1020157009313A priority patent/KR102081071B1/ko
Priority to PT137621074T priority patent/PT2895195T/pt
Priority to RU2015113306A priority patent/RU2676476C9/ru
Priority to RS20171339A priority patent/RS56699B1/sr
Publication of FR2995896A1 publication Critical patent/FR2995896A1/fr
Application granted granted Critical
Publication of FR2995896B1 publication Critical patent/FR2995896B1/fr
Priority to ZA2015/01493A priority patent/ZA201501493B/en
Priority to HK15107697.4A priority patent/HK1206994A1/xx
Priority to HK15112795.5A priority patent/HK1211854A1/xx
Priority to HRP20180019TT priority patent/HRP20180019T1/hr
Priority to CY20181100099T priority patent/CY1119984T1/el
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61P25/06—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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
FR1259064A 2012-09-11 2012-09-26 Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent. Expired - Fee Related FR2995896B1 (fr)

Priority Applications (38)

Application Number Priority Date Filing Date Title
FR1259064A FR2995896B1 (fr) 2012-09-26 2012-09-26 Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent.
JOP/2013/0247A JO3339B1 (ar) 2012-09-11 2013-08-20 شكل مستقر غير متبلور من الأغوميلاتين وعملية تحضيره والتركيبات الدوائية التي تحتوي عليه
UY0001035004A UY35004A (es) 2012-09-11 2013-08-30 Forma amorfa estabilizada de la agomelatina, su procedimiento de preparación y las composiciones farmacéuticas que la contienen
TW102131714A TWI581811B (zh) 2012-09-11 2013-09-03 包含非晶質形式之阿戈美拉汀（ａｇｏｍｅｌａｔｉｎｅ）之安定調配物及含有其之醫藥組合物
ARP130103199A AR092485A1 (es) 2012-09-11 2013-09-09 Forma amorfa estabilizada de la agomelatina, su procedimiento de preparacion y las composiciones farmaceuticas que la contienen
CN201910934869.6A CN110639021A (zh) 2012-09-11 2013-09-11 阿戈美拉汀的稳定的无定形形式、其制备方法和含有其的药物组合物
EA201500313A EA030645B1 (ru) 2012-09-11 2013-09-11 Стабилизированная аморфная форма агомелатина, способ ее изготовления и фармацевтические композиции, ее содержащие
PCT/EP2013/068792 WO2014041015A1 (fr) 2012-09-11 2013-09-11 Forme amorphe stabilisée d'agomélatine, procédé pour sa préparation et compositions pharmaceutiques la contenant
MEP-2018-2A ME02988B (fr) 2012-09-11 2013-09-11 Forme amorphe stabilisée d'agomélatine, procédé pour sa préparation et compositions pharmaceutiques la contenant
JP2015530452A JP6559065B2 (ja) 2012-09-11 2013-09-11 アゴメラチンの安定化非晶形、その調製方法及びこれを含有する医薬組成物
BR112015005303A BR112015005303A2 (pt) 2012-09-11 2013-09-11 forma amorfa estabilizada de agomelatina, processo para sua preparação e composições farmacêuticas contendo a mesma
AU2013314396A AU2013314396B2 (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it.
DK13762107.4T DK2895195T3 (en) 2012-09-11 2013-09-11 STABILIZED AMORPHOUS FORM OF AGOMELATIN, A PROCEDURE FOR ITS PREPARATION AND PHARMACEUTICAL COMPOSITION CONTAINING IT
EP13762107.4A EP2895195B1 (fr) 2012-09-11 2013-09-11 Forme amorphe stabilisée d'agomélatine, procédé pour sa préparation et compositions pharmaceutiques la contenant
NO13762107A NO2895195T3 (fr) 2012-09-11 2013-09-11
HUE13762107A HUE036043T2 (hu) 2012-09-11 2013-09-11 Agomelatin stabilizált amorf formája, eljárás elõállítására és az azt tartalmazó gyógyszerészeti készítmények
LTEP13762107.4T LT2895195T (lt) 2012-09-11 2013-09-11 Agomelatino stabilizuota amorfinė forma, jos gamybos būdas ir ją turinčios farmacinės kompozicijos
PL13762107T PL2895195T3 (pl) 2012-09-11 2013-09-11 Stabilizowana amorficzna postać agomelatyny, sposób jej wytwarzania i zawierająca ją kompozycja farmaceutyczna
MYPI2015700555A MY181682A (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it
US14/426,853 US20150238614A1 (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it
CN201380046980.2A CN104619346A (zh) 2012-09-11 2013-09-11 阿戈美拉汀的稳定的无定形形式、其制备方法和含有其的药物组合物
UAA201503239A UA116994C2 (uk) 2012-09-11 2013-09-11 Стабілізована аморфна форма агомелатину, спосіб її одержання і фармацевтичні композиції, які її містять
NZ705802A NZ705802A (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it.
ES13762107.4T ES2659196T3 (es) 2012-09-11 2013-09-11 Forma amorfa de agomelatina estabilizada, proceso para su preparación y composiciones farmacéuticas que la contienen
MX2015003015A MX358995B (es) 2012-09-11 2013-09-11 Forma amorfa estabilizada de agomelatina, un proceso para su preparación y composiciones farmacéuticas que la contienen.
GEAP201313784A GEP20186881B (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it
SG11201501333TA SG11201501333TA (en) 2012-09-11 2013-09-11 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it.
CA2882927A CA2882927C (fr) 2012-09-11 2013-09-11 Forme amorphe stabilisee d'agomelatine, procede pour sa preparation et compositions pharmaceutiques la contenant
KR1020157009313A KR102081071B1 (ko) 2012-09-11 2013-09-11 안정화된 무정형의 아고멜라틴, 이의 제조 방법 및 이를 함유하는 약제 조성물
PT137621074T PT2895195T (pt) 2012-09-11 2013-09-11 Forma amorfa estabilizada de agomelatina, um processo para a sua preparação e composições farmacêuticas que a contêm
RU2015113306A RU2676476C9 (ru) 2012-09-11 2013-09-11 Стабилизированная аморфная форма агомелатина, способ ее изготовления и фармацевтические композиции, ее содержащие
RS20171339A RS56699B1 (sr) 2012-09-11 2013-09-11 Stabilizovani amorfni oblik agomelatina, postupak za njegovu izradu i farmaceutske kompozicije koje ga sadrže
SI201330888T SI2895195T1 (en) 2012-09-11 2013-09-11 Stabilized amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions comprising
ZA2015/01493A ZA201501493B (en) 2012-09-11 2015-03-04 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it.
HK15107697.4A HK1206994A1 (en) 2012-09-11 2015-08-10 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it
HK15112795.5A HK1211854A1 (en) 2012-09-11 2015-12-29 Stabilised amorphous form of agomelatine, a process for its preparation and pharmaceutical compositions containing it
HRP20180019TT HRP20180019T1 (hr) 2012-09-11 2018-01-05 Stabilizirani amorfni oblik agomelatina, postupak za njegovu pripremu i farmaceutski pripravci koji ga sadržavaju
CY20181100099T CY1119984T1 (el) 2012-09-11 2018-01-24 Σταθεροποιημενη αμορφη μορφη αγομελατινης, μια μεθοδος για την παρασκευη της και φαρμακευτικες συνθεσεις που την περιεχουν

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR1259064A FR2995896B1 (fr) 2012-09-26 2012-09-26 Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent.

Publications (2)

Publication Number Publication Date
FR2995896A1 FR2995896A1 (fr) 2014-03-28
FR2995896B1 true FR2995896B1 (fr) 2014-11-21

Family

ID=47257952

Family Applications (1)

Application Number Title Priority Date Filing Date
FR1259064A Expired - Fee Related FR2995896B1 (fr) 2012-09-11 2012-09-26 Forme amorphe stabilisee de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent.

Country Status (2)

Country Link
CN (2) CN104619346A (fr)
FR (1) FR2995896B1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107556209A (zh) * 2016-06-30 2018-01-09 陕西合成药业股份有限公司 一种新型褪黑激素类化合物及其制备方法和在医学上的应用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2150525A1 (fr) * 2007-05-01 2010-02-10 Concert Pharmaceuticals Inc. Naphtyl(éthyl)acétamides
CN101836966A (zh) * 2010-05-27 2010-09-22 北京万全阳光医药科技有限公司 一种含有阿戈美拉汀的口腔崩解片
EP2705023A4 (fr) * 2011-01-04 2014-11-19 Symed Labs Ltd Procédés pour la préparation de n-[2-(7-méthoxy-1-naphtyléthyl]acétamide
CN102716493B (zh) * 2011-03-31 2014-05-28 天津药物研究院 含无定型态阿戈美拉汀的共聚物、其制备方法、其药物组合物及用途

Also Published As

Publication number Publication date
CN104619346A (zh) 2015-05-13
FR2995896A1 (fr) 2014-03-28
CN110639021A (zh) 2020-01-03

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