BR112015030373A2 - formulação farmacêutica de agomelatina para uso oral, processo de fabricação de uma formulação farmacêutica para uso oral, e, formulação farmacêutica - Google Patents

formulação farmacêutica de agomelatina para uso oral, processo de fabricação de uma formulação farmacêutica para uso oral, e, formulação farmacêutica

Info

Publication number
BR112015030373A2
BR112015030373A2 BR112015030373A BR112015030373A BR112015030373A2 BR 112015030373 A2 BR112015030373 A2 BR 112015030373A2 BR 112015030373 A BR112015030373 A BR 112015030373A BR 112015030373 A BR112015030373 A BR 112015030373A BR 112015030373 A2 BR112015030373 A2 BR 112015030373A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
oral
agomelatine
crystals
manufacturing process
Prior art date
Application number
BR112015030373A
Other languages
English (en)
Inventor
Hanovska Anna
Pribyl Daniel
Rezac Jaroslav
Dammer Ondrej
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 BR112015030373A2 publication Critical patent/BR112015030373A2/pt

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

Abstract

resumo formulação farmacêutica de agomelatina para uso oral, processo de fabricação de uma formulação farmacêutica para uso oral, e, formulação farmacêutica uma formulação farmacêutica de agomelatina para uso oral compreendendo agomelatina na forma de co-cristais de agomelatina com ácidos orgânicos e excipientes farmaceuticamente aceitáveis, em que os co-cristais de agomelatina são usados na forma de pré-misturas dos co- cristais de agomelatina com um agente lubrificante, a razão dos co-cristais de agomelatina em relação ao agente lubrificante na pré-mistura é menor que ou igual a 30 : 1, e o teor de água livre nos excipientes farmaceuticamente aceitáveis usados é menor que ou igual a 7 % p/p. 1/1
BR112015030373A 2013-06-06 2014-05-24 formulação farmacêutica de agomelatina para uso oral, processo de fabricação de uma formulação farmacêutica para uso oral, e, formulação farmacêutica BR112015030373A2 (pt)

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 (1)

Publication Number Publication Date
BR112015030373A2 true BR112015030373A2 (pt) 2017-07-25

Family

ID=48576707

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112015030373A BR112015030373A2 (pt) 2013-06-06 2014-05-24 formulação farmacêutica de agomelatina para uso oral, processo de fabricação de uma formulação farmacêutica para uso oral, e, formulação farmacêutica

Country Status (13)

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

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
JP6931884B2 (ja) * 2016-02-12 2021-09-08 テイカ製薬株式会社 乾式造粒物及び該乾式造粒物を含有する固形製剤並びにそれらの製造方法
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
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
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
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
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
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
PH12012000132B1 (en) * 2011-06-09 2014-10-20 Servier Lab New co-crystals of agomelatine, a process for their preparation and pharmaceutical compositions containing them
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.
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
KR20160014619A (ko) 2016-02-11
EA028732B1 (ru) 2017-12-29
EA201592297A1 (ru) 2016-05-31
WO2014194992A1 (en) 2014-12-11
ES2645223T3 (es) 2017-12-04
MX2015016679A (es) 2016-07-15
EP2810656A1 (en) 2014-12-10
PL2810656T3 (pl) 2018-01-31
EP2810656B1 (en) 2017-08-02
JP6453858B2 (ja) 2019-01-16
CN105579065B (zh) 2018-11-16
JP2016520629A (ja) 2016-07-14
HUE036989T2 (hu) 2018-08-28
IL242711B (en) 2019-05-30
MX362717B (es) 2019-01-25
PT2810656T (pt) 2017-11-13
CN105579065A (zh) 2016-05-11

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements
B350 Update of information on the portal [chapter 15.35 patent gazette]