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MX2015016679A - Formulaciones de agomelatina que comprenden agomelatina en forma de cocristales. - Google Patents

Formulaciones de agomelatina que comprenden agomelatina en forma de cocristales.

Info

Publication number
MX2015016679A
MX2015016679A MX2015016679A MX2015016679A MX2015016679A MX 2015016679 A MX2015016679 A MX 2015016679A MX 2015016679 A MX2015016679 A MX 2015016679A MX 2015016679 A MX2015016679 A MX 2015016679A MX 2015016679 A MX2015016679 A MX 2015016679A
Authority
MX
Mexico
Prior art keywords
agomelatine
crystals
formulations
glidant
blend
Prior art date
Application number
MX2015016679A
Other languages
English (en)
Other versions
MX362717B (es
Inventor
Ondrej Dammer
Jaroslav Rezac
Daniel Pribyl
Anna Hanovska
Original Assignee
Zentiva Ks
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 Zentiva Ks filed Critical Zentiva Ks
Publication of MX2015016679A publication Critical patent/MX2015016679A/es
Publication of MX362717B publication Critical patent/MX362717B/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61P25/24—Antidepressants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Anesthesiology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una formulación farmacéutica de la agomelatina para uso oral, que comprende - agomelatina en forma de co-cristales de agomelatina con ácidos orgánicos y - excipientes farmacéuticamente aceptables, en la que - los co-cristales de agomelatina se utilizan en forma de premezcla de los cocristales de agomelatina con un deslizante, - la relación de los co-cristales de agomelatina con el deslizante en la premezcla es menor de o igual a 30: 1 , y - el contenido de agua libre en los excipientes farmacéuticamente aceptables utilizados es menor de o igual al 7 % p/p.
MX2015016679A 2013-06-06 2014-05-24 Formulaciones de agomelatina que comprenden agomelatina en forma de cocristales. MX362717B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13002930.9A EP2810656B1 (en) 2013-06-06 2013-06-06 Agomelatine formulations comprising agomelatine in the form of co-crystals
PCT/EP2014/001410 WO2014194992A1 (en) 2013-06-06 2014-05-24 Agomelatine formulations comprising agomelatine in the form of co-crystals

Publications (2)

Publication Number Publication Date
MX2015016679A true MX2015016679A (es) 2016-07-15
MX362717B MX362717B (es) 2019-01-25

Family

ID=48576707

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015016679A MX362717B (es) 2013-06-06 2014-05-24 Formulaciones de agomelatina que comprenden agomelatina en forma de cocristales.

Country Status (13)

Country Link
EP (1) EP2810656B1 (es)
JP (1) JP6453858B2 (es)
KR (1) KR20160014619A (es)
CN (1) CN105579065B (es)
BR (1) BR112015030373A2 (es)
EA (1) EA028732B1 (es)
ES (1) ES2645223T3 (es)
HU (1) HUE036989T2 (es)
IL (1) IL242711B (es)
MX (1) MX362717B (es)
PL (1) PL2810656T3 (es)
PT (1) PT2810656T (es)
WO (1) WO2014194992A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3034070A1 (en) * 2014-12-18 2016-06-22 Omya International AG Method for the production of a pharmaceutical delivery system
TWI781921B (zh) 2016-02-12 2022-11-01 日商特一華製藥股份有限公司 乾式造粒物及含有該乾式造粒物之固形製劑以及其製造方法
EP3466413A1 (en) 2017-10-09 2019-04-10 KRKA, d.d., Novo mesto Pharmaceutical composition containing agomelatine and process for the preparation thereof

Family Cites Families (25)

* Cited by examiner, † Cited by third party
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.
FR2795326B1 (fr) 1999-06-28 2001-08-31 Adir Composition pharmaceutique solide thermoformable a liberation controlee
FR2834890B1 (fr) 2002-01-23 2004-02-27 Servier Lab Composition pharmaceutique orodispersible d'agomelatine
FR2866335B1 (fr) 2004-02-13 2006-05-26 Servier Lab Nouveau procede de synthese de l'agomelatine
GB0423964D0 (en) * 2004-10-28 2004-12-01 Jagotec Ag Dosage form
FR2889521B1 (fr) 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline iii de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
FR2889522B1 (fr) 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline iv de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
FR2889523B1 (fr) 2005-08-03 2007-12-28 Servier Lab Nouvelle forme cristalline v de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
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
FR2894475B1 (fr) * 2005-12-14 2008-05-16 Servier Lab Composition pharmaceutique orodispersible pour administra- -tion oromucosale ou sublinguale d'agomelatine
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
FR2908995B1 (fr) 2006-11-24 2009-02-06 Servier Lab Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement du syndrome de smith magenis
FR2908994B1 (fr) 2006-11-24 2009-04-03 Servier Lab Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement de la leucomalacie periventriculaire
FR2923482B1 (fr) 2007-11-09 2010-01-29 Servier Lab Nouvelle forme cristalline vi de l'agomelatine, son procede de preparation et les compositions pharmaceutiques qui la contiennent
CN102106807B (zh) 2009-12-29 2013-03-27 上海中西制药有限公司 一种固体制剂的制备方法及所得固体制剂
CN101766573B (zh) * 2010-02-05 2013-02-13 上海安必生制药技术有限公司 硫酸氢氯吡格雷固体制剂的制备工艺
FR2956031B1 (fr) * 2010-02-11 2012-03-02 Servier Lab Utilisation de l'agomelatine pour l'obtention de medicaments destines au traitement du trouble obsessionnel compulsif (toc)
CN102342924A (zh) * 2010-08-05 2012-02-08 北京本草天源药物研究院 一种含有阿戈美拉汀的药物组合物
CN101991559B (zh) 2010-11-25 2012-04-18 天津市汉康医药生物技术有限公司 一种稳定的阿戈美拉汀胶囊药物组合物
CN102552188B (zh) * 2010-12-17 2013-12-25 北大方正集团有限公司 一种阿戈美拉汀片剂及制备方法、其包衣片剂及制备方法
RS52982B (sr) 2011-04-28 2014-02-28 Zentiva, K.S. Farmaceutski prihvatljivi kokristali n-[2-(7-metoksi-1-naftil]acetamida i postupci njihove izrade
EP2522823B1 (fr) * 2011-05-13 2014-04-23 Aaqius & Aaqius S.A. Dispositif de mesure d'une quantité d'un agent réducteur, de préférence de NH3, contenu dans un réservoir
FR2976284B1 (fr) * 2011-06-09 2013-05-24 Servier Lab Nouveaux co-cristaux d'agomelatine, leur procede de preparation et les compositions pharmaceutiques qui les contiennent.
PH12012000132A1 (en) 2011-06-09 2014-10-20 Servier Lab New co-crystals of agomelatine, a process for their preparation and pharmaceutical compositions containing them
CN102247376B (zh) * 2011-08-15 2012-11-28 华润赛科药业有限责任公司 复方缬沙坦氢氯噻嗪固体制剂及其制备方法

Also Published As

Publication number Publication date
EA201592297A1 (ru) 2016-05-31
JP2016520629A (ja) 2016-07-14
KR20160014619A (ko) 2016-02-11
CN105579065A (zh) 2016-05-11
MX362717B (es) 2019-01-25
EP2810656B1 (en) 2017-08-02
HUE036989T2 (hu) 2018-08-28
WO2014194992A1 (en) 2014-12-11
CN105579065B (zh) 2018-11-16
IL242711B (en) 2019-05-30
EA028732B1 (ru) 2017-12-29
PT2810656T (pt) 2017-11-13
JP6453858B2 (ja) 2019-01-16
PL2810656T3 (pl) 2018-01-31
ES2645223T3 (es) 2017-12-04
BR112015030373A2 (pt) 2017-07-25
EP2810656A1 (en) 2014-12-10

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