CN109310621A - 氟维司群制剂和其使用方法 - Google Patents

氟维司群制剂和其使用方法 Download PDF

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Publication number
CN109310621A
CN109310621A CN201780027809.5A CN201780027809A CN109310621A CN 109310621 A CN109310621 A CN 109310621A CN 201780027809 A CN201780027809 A CN 201780027809A CN 109310621 A CN109310621 A CN 109310621A
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CN
China
Prior art keywords
fulvestrant
microns
suspension
pharmaceutical composition
aqueous
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201780027809.5A
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English (en)
Chinese (zh)
Inventor
峰-京·陈
史蒂芬·L·克里尔
拉马·阿布·什梅斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eagle Pharmaceuticals Inc
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Eagle Pharmaceuticals Inc
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Publication date
Application filed by Eagle Pharmaceuticals Inc filed Critical Eagle Pharmaceuticals Inc
Publication of CN109310621A publication Critical patent/CN109310621A/zh
Pending legal-status Critical Current

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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

Landscapes

  • 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)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (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)
CN201780027809.5A 2016-05-06 2017-05-05 氟维司群制剂和其使用方法 Pending CN109310621A (zh)

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 (1)

Publication Number Publication Date
CN109310621A true CN109310621A (zh) 2019-02-05

Family

ID=58709642

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201780027809.5A Pending CN109310621A (zh) 2016-05-06 2017-05-05 氟维司群制剂和其使用方法

Country Status (15)

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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021115389A1 (zh) * 2019-12-11 2021-06-17 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用
CN114617847A (zh) * 2020-12-10 2022-06-14 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用

Families Citing this family (6)

* Cited by examiner, † Cited by third party
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US11590077B2 (en) 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use
EP3706719A1 (en) 2017-11-08 2020-09-16 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use
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
CN114504551B (zh) * 2020-11-16 2024-01-02 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
JP2024545690A (ja) * 2021-12-20 2024-12-10 サムヤン、ホールディングス、コーポレーション 溶解度が改善されたフルベストラントの医薬組成物及びその製造方法
KR20240105964A (ko) * 2022-12-29 2024-07-08 주식회사 삼양홀딩스 약동학적 특성이 우수한 풀베스트란트의 약학 조성물 및 그 제조 방법

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CN1429101A (zh) * 2000-05-15 2003-07-09 法玛西雅意大利公司 用于肠胃外给药的稳定水性混悬液
CN101108168A (zh) * 2007-08-03 2008-01-23 西安力邦医药科技有限责任公司 一种氟维司群缓释微球的制备方法
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021115389A1 (zh) * 2019-12-11 2021-06-17 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用
CN113260353A (zh) * 2019-12-11 2021-08-13 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用
CN113260353B (zh) * 2019-12-11 2024-11-29 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
US12377049B2 (en) 2019-12-11 2025-08-05 Shanghai Bocimed Pharmaceutical Co., Ltd. Fulvestrant pharmaceutical composition, preparation method therefor, and application thereof
CN114617847A (zh) * 2020-12-10 2022-06-14 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用
WO2022121961A1 (zh) * 2020-12-10 2022-06-16 上海博志研新药物技术有限公司 氟维司群药物组合物、其制备方法及应用
TWI905338B (zh) * 2020-12-10 2025-11-21 大陸商上海雲晟研新生物科技有限公司 氟維司群藥物組合物、其製備方法及應用

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MY205661A (en) 2024-11-04
BR112018072768A2 (pt) 2019-02-19
UA125514C2 (uk) 2022-04-13
IL262465A (en) 2018-12-31
MX2018013414A (es) 2019-06-06
CA3022834A1 (en) 2017-11-09
JP2019516789A (ja) 2019-06-20
EP3452011A1 (en) 2019-03-13
AU2017261321B2 (en) 2023-03-09
JP2021169510A (ja) 2021-10-28
CO2018013257A2 (es) 2018-12-28
WO2017193048A1 (en) 2017-11-09
US20190134059A1 (en) 2019-05-09
MX2022013199A (es) 2022-12-13
MA44862A (fr) 2019-03-13
US12370199B2 (en) 2025-07-29
AU2017261321A1 (en) 2018-11-15
AU2023203392A1 (en) 2023-06-29
JP2023109959A (ja) 2023-08-08
KR20190005183A (ko) 2019-01-15
RU2018142068A3 (https=) 2020-09-17
KR102438425B1 (ko) 2022-09-01
IL285928A (en) 2021-10-31
ZA201807031B (en) 2023-10-25
IL285928B1 (en) 2025-02-01
JP7312523B2 (ja) 2023-07-21
US20210346396A1 (en) 2021-11-11
RU2018142068A (ru) 2020-06-08
IL285928B2 (en) 2025-06-01
NZ747911A (en) 2025-03-28

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