KR102438425B1 - 풀베스트란트 제제 및 그의 사용 방법 - Google Patents

풀베스트란트 제제 및 그의 사용 방법 Download PDF

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KR102438425B1
KR102438425B1 KR1020187034942A KR20187034942A KR102438425B1 KR 102438425 B1 KR102438425 B1 KR 102438425B1 KR 1020187034942 A KR1020187034942 A KR 1020187034942A KR 20187034942 A KR20187034942 A KR 20187034942A KR 102438425 B1 KR102438425 B1 KR 102438425B1
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micrometers
fulvestrant
pharmaceutical composition
micrometer
suspension
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KR20190005183A (ko
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펑-징 천
스티븐 엘. 크릴
라마 아부 샤메이스
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이글 파마슈티컬즈 인코포레이티드
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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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/32—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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020187034942A 2016-05-06 2017-05-05 풀베스트란트 제제 및 그의 사용 방법 Active KR102438425B1 (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662332842P 2016-05-06 2016-05-06
US62/332,842 2016-05-06
US201662420555P 2016-11-10 2016-11-10
US62/420,555 2016-11-10
PCT/US2017/031376 WO2017193048A1 (en) 2016-05-06 2017-05-05 Fulvestrant formulations and methods of their use

Publications (2)

Publication Number Publication Date
KR20190005183A KR20190005183A (ko) 2019-01-15
KR102438425B1 true KR102438425B1 (ko) 2022-09-01

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Country Status (15)

Country Link
US (2) US20190134059A1 (enExample)
EP (1) EP3452011A1 (enExample)
JP (3) JP2019516789A (enExample)
KR (1) KR102438425B1 (enExample)
CN (1) CN109310621A (enExample)
AU (2) AU2017261321B2 (enExample)
CA (1) CA3022834A1 (enExample)
CO (1) CO2018013257A2 (enExample)
IL (2) IL285928B2 (enExample)
MA (1) MA44862A (enExample)
MX (2) MX2018013414A (enExample)
MY (1) MY205661A (enExample)
UA (1) UA125514C2 (enExample)
WO (1) WO2017193048A1 (enExample)
ZA (1) ZA201807031B (enExample)

Families Citing this family (8)

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US11590077B2 (en) 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use
BR112020009141A2 (pt) * 2017-11-08 2020-10-27 Eagle Pharmaceuticals, Inc. método para tratar câncer de mama num indivíduo
EP4074304A4 (en) * 2019-12-11 2024-01-10 Shanghai Bocimed Pharmaceutical Co., Ltd. PHARMACEUTICAL COMPOSITION OF FULVESTRANT, PREPARATION METHOD AND APPLICATION THEREOF
CN113694017B (zh) * 2020-05-11 2024-04-02 鲁南制药集团股份有限公司 一种氟维司群注射制剂及其制备方法
WO2022100750A1 (zh) * 2020-11-16 2022-05-19 北京厚燊维康科技有限责任公司 可用于光动力治疗或诊断的制剂
CN120284882A (zh) * 2020-12-10 2025-07-11 上海云晟研新生物科技有限公司 氟维司群药物组合物、其制备方法及应用
WO2023121232A1 (ko) * 2021-12-20 2023-06-29 주식회사 삼양홀딩스 용해도가 개선된 풀베스트란트의 약학 조성물 및 그 제조 방법
KR20240105964A (ko) * 2022-12-29 2024-07-08 주식회사 삼양홀딩스 약동학적 특성이 우수한 풀베스트란트의 약학 조성물 및 그 제조 방법

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Publication number Publication date
AU2017261321B2 (en) 2023-03-09
US20210346396A1 (en) 2021-11-11
CO2018013257A2 (es) 2018-12-28
MY205661A (en) 2024-11-04
RU2018142068A3 (enExample) 2020-09-17
US12370199B2 (en) 2025-07-29
BR112018072768A2 (pt) 2019-02-19
KR20190005183A (ko) 2019-01-15
JP2023109959A (ja) 2023-08-08
JP2019516789A (ja) 2019-06-20
RU2018142068A (ru) 2020-06-08
MX2018013414A (es) 2019-06-06
NZ747911A (en) 2025-03-28
ZA201807031B (en) 2023-10-25
AU2023203392A1 (en) 2023-06-29
US20190134059A1 (en) 2019-05-09
EP3452011A1 (en) 2019-03-13
MX2022013199A (es) 2022-12-13
CA3022834A1 (en) 2017-11-09
IL262465A (en) 2018-12-31
IL285928B1 (en) 2025-02-01
UA125514C2 (uk) 2022-04-13
IL285928B2 (en) 2025-06-01
CN109310621A (zh) 2019-02-05
MA44862A (fr) 2019-03-13
AU2017261321A1 (en) 2018-11-15
IL285928A (en) 2021-10-31
JP7312523B2 (ja) 2023-07-21
JP2021169510A (ja) 2021-10-28
WO2017193048A1 (en) 2017-11-09

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