BR112019023781A2 - Composição farmacêutica em uma forma de unidade de dosagem e processo para preparação da composição farmacêutica - Google Patents

Composição farmacêutica em uma forma de unidade de dosagem e processo para preparação da composição farmacêutica Download PDF

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Publication number
BR112019023781A2
BR112019023781A2 BR112019023781-0A BR112019023781A BR112019023781A2 BR 112019023781 A2 BR112019023781 A2 BR 112019023781A2 BR 112019023781 A BR112019023781 A BR 112019023781A BR 112019023781 A2 BR112019023781 A2 BR 112019023781A2
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BR
Brazil
Prior art keywords
weight
formulation
acid
capsule
pellets
Prior art date
Application number
BR112019023781-0A
Other languages
English (en)
Portuguese (pt)
Inventor
Türkyilmaz Ali
Palantöken Arzu
Uraz Ezel
Gülkok Yildiz
Original Assignee
Sanovel Ilac Sanayi Ve Ticaret Anomim Sirketi
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64559741&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112019023781(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanovel Ilac Sanayi Ve Ticaret Anomim Sirketi filed Critical Sanovel Ilac Sanayi Ve Ticaret Anomim Sirketi
Priority claimed from PCT/TR2018/050221 external-priority patent/WO2019004980A2/fr
Publication of BR112019023781A2 publication Critical patent/BR112019023781A2/pt

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
BR112019023781-0A 2017-05-10 2018-05-10 Composição farmacêutica em uma forma de unidade de dosagem e processo para preparação da composição farmacêutica BR112019023781A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
TR2017/06848A TR201706848A2 (tr) 2017-05-10 2017-05-10 Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar
TR2017/06848 2017-05-10
TR2018/06309 2018-05-04
TR2018/06309A TR201806309A2 (tr) 2017-05-10 2018-05-04 Dabigatran eteksi̇lat i̇çeren kati oral farmasöti̇k kompozi̇syonlar
PCT/TR2018/050221 WO2019004980A2 (fr) 2017-05-10 2018-05-10 Compositions pharmaceutiques orales solides d'étéxilate de dabigatran

Publications (1)

Publication Number Publication Date
BR112019023781A2 true BR112019023781A2 (pt) 2020-06-02

Family

ID=64559741

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019023781-0A BR112019023781A2 (pt) 2017-05-10 2018-05-10 Composição farmacêutica em uma forma de unidade de dosagem e processo para preparação da composição farmacêutica

Country Status (8)

Country Link
EP (2) EP3621599A2 (fr)
AU (1) AU2018293361B2 (fr)
BR (1) BR112019023781A2 (fr)
CO (1) CO2019013649A2 (fr)
EA (1) EA201992644A1 (fr)
NZ (1) NZ759901A (fr)
TR (2) TR201706848A2 (fr)
WO (1) WO2019004979A2 (fr)

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE121699A1 (es) 1997-02-18 1999-12-08 Boehringer Ingelheim Pharma Heterociclos biciclicos disustituidos como inhibidores de la trombina
DE10337697A1 (de) 2003-08-16 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tablette enthaltend 3-[(2-{[4-(Hexyloxycarbonylamino-imino-methyl)-phenyl-amino]-methyl}-1-methyl-1H-benzimidazol-5-carbonyl)-pyridin-2-yl-amino]-propionsäure-ethylester oder dessen Salze
PT2588090T (pt) 2010-07-01 2017-06-26 Krka Tovarna Zdravil D D Novo Mesto Formas de dosagem oral farmacêuticas compreendendo dabigatrano etexilato e os seus sais farmaceuticamente aceitáveis
ES2895918T3 (es) * 2012-02-21 2022-02-23 Towa Pharmaceutical Europe S L Composiciones farmacéuticas orales de dabigatrán etexilato
EP2740471B1 (fr) 2012-12-07 2015-05-27 Hexal AG Composition pharmaceutique orale comprenant le dabigatran etexilate
CN104784147B (zh) * 2014-01-20 2018-01-23 成都苑东生物制药股份有限公司 一种甲磺酸达比加群酯胶囊药物组合物及其制备方法
IN2014MU01042A (fr) 2014-03-26 2015-10-02 Cadila Healthcare Ltd
EP2929884A1 (fr) * 2014-04-11 2015-10-14 Sanovel Ilac Sanayi ve Ticaret A.S. Combinaisons pharmaceutiques de dabigatran et antagonistes du récepteur de h2
CN104095830A (zh) * 2014-05-22 2014-10-15 万特制药(海南)有限公司 一种甲磺酸盐达比加群酯胶囊的制备方法
CN105560206A (zh) * 2014-10-13 2016-05-11 重庆圣华曦药业股份有限公司 一种达比加群酯胶囊的制备
WO2016142821A2 (fr) * 2015-03-09 2016-09-15 Alphamed Formulations Pvt. Ltd Compositions contenant un inhibiteur de la thrombine
IN2015CH01145A (fr) * 2015-03-09 2016-09-16

Also Published As

Publication number Publication date
EP3621599A2 (fr) 2020-03-18
WO2019004979A2 (fr) 2019-01-03
TR201706848A2 (tr) 2018-11-21
CO2019013649A2 (es) 2020-05-15
AU2018293361A1 (en) 2020-01-02
TR201806309A2 (tr) 2018-11-21
NZ759901A (en) 2021-12-24
EP3634388A2 (fr) 2020-04-15
WO2019004979A3 (fr) 2019-04-11
EA201992644A1 (ru) 2020-04-07
AU2018293361B2 (en) 2021-09-16

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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]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements