EA201990223A1 - Фармацевтическая композиция для перорального приема с контролируемой скоростью растворения, содержащая пеллеты с замедленным высвобождением, содержащие тамсулозина гидрохлорид - Google Patents
Фармацевтическая композиция для перорального приема с контролируемой скоростью растворения, содержащая пеллеты с замедленным высвобождением, содержащие тамсулозина гидрохлоридInfo
- Publication number
- EA201990223A1 EA201990223A1 EA201990223A EA201990223A EA201990223A1 EA 201990223 A1 EA201990223 A1 EA 201990223A1 EA 201990223 A EA201990223 A EA 201990223A EA 201990223 A EA201990223 A EA 201990223A EA 201990223 A1 EA201990223 A1 EA 201990223A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- release pellets
- oral administration
- pharmaceutical composition
- controlled dissolution
- dissolution speed
- Prior art date
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- 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
- A61K31/18—Sulfonamides
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/472—Non-condensed isoquinolines, e.g. papaverine
- A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K9/1682—Processes
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- 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
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- 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
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- 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
- A61K9/4866—Organic macromolecular compounds
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- 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
-
- 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
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- 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
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
В настоящем изобретении предложен фармацевтический препарат для перорального приема с контролируемой скоростью растворения, содержащий пеллеты с замедленным высвобождением, содержащие тамсулозина гидрохлорид, где указанные пеллеты с замедленным высвобождением содержат: 1) тамсулозина гидрохлорид, 2) гидроксипропилметилцеллюлозу (HPMC), 3) кислотоустойчивый акриловый полимер и 4) два или более чем два типа нерастворимых разбавителей; а также способ его изготовления. Согласно настоящему изобретению пеллеты с замедленным высвобождением, содержащие тамсулозина гидрохлорид, заданного размера могут быть получены с воспроизводимостью, тем самым обеспечивая контролирование скорости высвобождения и уменьшение размера пеллет, и следовательно улучшая соблюдение схемы приема лекарственного средства.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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KR20160103269 | 2016-08-12 | ||
PCT/KR2017/008800 WO2018030862A1 (ko) | 2016-08-12 | 2017-08-11 | 탐수로신 염산염 함유 서방성 펠렛을 포함하는 용출률이 제어된 경구투여용 약제학적 제제 |
Publications (1)
Publication Number | Publication Date |
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EA201990223A1 true EA201990223A1 (ru) | 2019-07-31 |
Family
ID=61163047
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EA201990223A EA201990223A1 (ru) | 2016-08-12 | 2017-08-11 | Фармацевтическая композиция для перорального приема с контролируемой скоростью растворения, содержащая пеллеты с замедленным высвобождением, содержащие тамсулозина гидрохлорид |
Country Status (12)
Country | Link |
---|---|
US (1) | US20190167612A1 (ru) |
EP (1) | EP3498264B1 (ru) |
JP (1) | JP7004224B2 (ru) |
KR (1) | KR102391496B1 (ru) |
CN (1) | CN109562072B (ru) |
AU (1) | AU2017308461A1 (ru) |
BR (1) | BR112019002635A2 (ru) |
EA (1) | EA201990223A1 (ru) |
ES (1) | ES2967085T3 (ru) |
MX (1) | MX2019001741A (ru) |
PH (1) | PH12019500276A1 (ru) |
WO (1) | WO2018030862A1 (ru) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102169926B1 (ko) * | 2018-01-12 | 2020-10-26 | 주식회사 종근당 | 탐스로신과 타다라필을 포함하는 약제학적 조성물 |
ES2967689T3 (es) | 2018-04-06 | 2024-05-03 | Capsugel Belgium Nv | Proceso de secado por aspersión para partículas de baja relación de aspecto que comprenden poli[(metacrilato de metilo)-co-(ácido metacrílico)] |
KR20200078121A (ko) | 2018-12-21 | 2020-07-01 | 한미약품 주식회사 | 탐수로신 및 솔리페나신을 포함하는 경구용 복합제제 및 그 제조방법 |
KR20200121183A (ko) | 2019-04-15 | 2020-10-23 | 한미약품 주식회사 | 탐스로신 및 솔리페나신을 포함하는 복합제제 및 그 제조방법 |
KR20210003323A (ko) * | 2019-07-01 | 2021-01-12 | 한미약품 주식회사 | 탐수로신 또는 이의 염산염 함유 제약 조성물 및 이의 제조방법 |
AU2021265311A1 (en) * | 2020-04-27 | 2022-12-08 | Zim Laboratories Limited | Novel multiparticulate pharmaceutical composition of tamsulosin and solifenacin |
CN113189239B (zh) * | 2021-05-06 | 2023-04-14 | 山东省药学科学院 | 一种用高效液相色谱法测定右兰索拉唑缓释胶囊中小丸i含量的方法 |
WO2023072872A1 (en) | 2021-10-25 | 2023-05-04 | Farmalíder, S.A. | Tadalafil oral suspension |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR930007245A (ko) | 1991-09-16 | 1993-04-22 | 강진구 | 영상신호 수신 장치 |
JP2007507491A (ja) * | 2003-09-29 | 2007-03-29 | シージェー コーポレーション | 徐放性製剤 |
KR100762846B1 (ko) * | 2003-09-29 | 2007-10-04 | 씨제이 주식회사 | 서방성 제제 |
KR100570419B1 (ko) * | 2004-01-14 | 2006-04-11 | 코오롱제약주식회사 | 염산 탐술로신의 경구 투여용 서방성 펠렛 조성물 및 그제조방법 |
KR100582350B1 (ko) | 2004-02-17 | 2006-05-22 | 한미약품 주식회사 | 탐수로신 염산염의 경구투여용 조성물 및 이의 서방성과립 제제 |
KR20060093931A (ko) * | 2005-02-23 | 2006-08-28 | 센츄론(주) | 펠렛타입의 방출제어형 탐술로신 제제 |
KR100912680B1 (ko) * | 2006-03-16 | 2009-08-19 | (주) 벡스코아 | 제어 방출 제형 |
AU2008365126A1 (en) * | 2008-12-09 | 2011-06-30 | Synthon B.V. | Tamsulosin pellets for fixed dose combination |
KR101686033B1 (ko) * | 2010-04-12 | 2016-12-13 | 주식회사 대웅제약 | 탐술로신 또는 이의 약제학적 허용 가능한 염을 유효성분으로 함유하는 장용성 서방형 펠렛부와 속방부로 이루어진 의약 조성물 |
CN103585112B (zh) * | 2012-08-14 | 2015-08-12 | 齐鲁制药有限公司 | 一种坦洛新肠溶缓释微丸及其制备方法 |
KR20160100570A (ko) * | 2015-02-16 | 2016-08-24 | 한미약품 주식회사 | 탐수로신 염산염 함유 서방성 과립을 포함하는 경구용 약제학적 제제 |
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2017
- 2017-08-11 WO PCT/KR2017/008800 patent/WO2018030862A1/ko unknown
- 2017-08-11 AU AU2017308461A patent/AU2017308461A1/en not_active Abandoned
- 2017-08-11 KR KR1020170102553A patent/KR102391496B1/ko active IP Right Grant
- 2017-08-11 US US16/324,648 patent/US20190167612A1/en not_active Abandoned
- 2017-08-11 CN CN201780049450.1A patent/CN109562072B/zh active Active
- 2017-08-11 EP EP17839879.8A patent/EP3498264B1/en active Active
- 2017-08-11 JP JP2019506094A patent/JP7004224B2/ja active Active
- 2017-08-11 MX MX2019001741A patent/MX2019001741A/es unknown
- 2017-08-11 ES ES17839879T patent/ES2967085T3/es active Active
- 2017-08-11 BR BR112019002635A patent/BR112019002635A2/pt active Search and Examination
- 2017-08-11 EA EA201990223A patent/EA201990223A1/ru unknown
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2019
- 2019-02-08 PH PH12019500276A patent/PH12019500276A1/en unknown
Also Published As
Publication number | Publication date |
---|---|
CN109562072A (zh) | 2019-04-02 |
PH12019500276A1 (en) | 2019-05-15 |
KR102391496B1 (ko) | 2022-04-28 |
US20190167612A1 (en) | 2019-06-06 |
JP7004224B2 (ja) | 2022-02-10 |
MX2019001741A (es) | 2019-12-09 |
WO2018030862A1 (ko) | 2018-02-15 |
JP2019527700A (ja) | 2019-10-03 |
EP3498264A1 (en) | 2019-06-19 |
ES2967085T3 (es) | 2024-04-26 |
KR20180018450A (ko) | 2018-02-21 |
BR112019002635A2 (pt) | 2019-05-28 |
CN109562072B (zh) | 2022-04-05 |
AU2017308461A1 (en) | 2019-02-28 |
EP3498264A4 (en) | 2020-03-11 |
EP3498264B1 (en) | 2023-11-08 |
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