IL285928B2 - Fulvestrant formulations and methods of their use - Google Patents

Fulvestrant formulations and methods of their use

Info

Publication number
IL285928B2
IL285928B2 IL285928A IL28592821A IL285928B2 IL 285928 B2 IL285928 B2 IL 285928B2 IL 285928 A IL285928 A IL 285928A IL 28592821 A IL28592821 A IL 28592821A IL 285928 B2 IL285928 B2 IL 285928B2
Authority
IL
Israel
Prior art keywords
microns
fulvestrant
suspension
range
pharmaceutical composition
Prior art date
Application number
IL285928A
Other languages
English (en)
Hebrew (he)
Other versions
IL285928A (en
IL285928B1 (en
Original Assignee
Eagle Pharmaceuticals Inc
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 Eagle Pharmaceuticals Inc filed Critical Eagle Pharmaceuticals Inc
Publication of IL285928A publication Critical patent/IL285928A/en
Publication of IL285928B1 publication Critical patent/IL285928B1/en
Publication of IL285928B2 publication Critical patent/IL285928B2/en

Links

Classifications

    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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)
IL285928A 2016-05-06 2017-05-04 Fulvestrant formulations and methods of their use IL285928B2 (en)

Applications Claiming Priority (3)

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

Publications (3)

Publication Number Publication Date
IL285928A IL285928A (en) 2021-10-31
IL285928B1 IL285928B1 (en) 2025-02-01
IL285928B2 true IL285928B2 (en) 2025-06-01

Family

ID=58709642

Family Applications (2)

Application Number Title Priority Date Filing Date
IL285928A IL285928B2 (en) 2016-05-06 2017-05-04 Fulvestrant formulations and methods of their use
IL262465A IL262465A (en) 2016-05-06 2018-10-18 Fulvestrant formulations and methods of using them

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL262465A IL262465A (en) 2016-05-06 2018-10-18 Fulvestrant formulations and methods of using them

Country Status (15)

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

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11590077B2 (en) 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use
MY204442A (en) * 2017-11-08 2024-08-28 Eagle Pharmaceuticals Inc Fulvestrant formulations and methods of their use
US12377049B2 (en) * 2019-12-11 2025-08-05 Shanghai Bocimed Pharmaceutical Co., Ltd. Fulvestrant pharmaceutical composition, preparation method therefor, 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
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
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
KR20230094172A (ko) * 2021-12-20 2023-06-27 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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030114430A1 (en) * 2000-05-15 2003-06-19 Macleod Steven K. Stabilized injectable suspension of a steroidal drug
US6774122B2 (en) * 2000-01-10 2004-08-10 Astrazeneca Ab Formulation
WO2012035516A1 (en) * 2010-09-16 2012-03-22 Henk Swart Fulvestrant compositions and methods of use
EP2460539A1 (en) * 2009-07-31 2012-06-06 Xi'an Libang Medical Technology Co., Ltd. Nanosphere or microsphere drug carrier, preparation method, composition and use thereof

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8853260B2 (en) 1997-06-27 2014-10-07 Abraxis Bioscience, Llc Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
WO2001087262A2 (en) 2000-05-15 2001-11-22 Pharmacia Italia S.P.A. Stabilized steroidal suspension
GB0116619D0 (en) * 2001-07-07 2001-08-29 Astrazeneca Ab Formulation
RU2004102393A (ru) * 2001-07-07 2005-03-27 Астразенека Аб (Se) Фармацевтическая композиция для внутримышечного введения фульвестранта
JP2003298516A (ja) 2002-03-29 2003-10-17 Fujitsu Ltd 波長分散補償装置
PL1778187T3 (pl) 2004-08-04 2012-09-28 Camurus Ab Kompozycje tworzące nielamelarne dyspersje
US8226926B2 (en) 2005-05-09 2012-07-24 Biosphere Medical, S.A. Compositions and methods using microspheres and non-ionic contrast agents
CA2626016A1 (en) 2005-10-21 2007-06-21 Panacea Biotec Limited Pharmaceutical composition comprising at least one anticancer drug and at least one polymer
US8158152B2 (en) 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
CN101108168B (zh) * 2007-08-03 2010-12-08 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
EP2200588B1 (en) 2007-09-25 2019-03-20 Solubest Ltd. Compositions comprising lipophilic active compounds and method for their preparation
CA2716576A1 (en) 2008-03-07 2009-09-11 Nageswara R. Palepu Fulvestrant formulations
TW201016220A (en) * 2008-10-31 2010-05-01 Scinopharm Taiwan Ltd Micronization form of 7α-[9-(4,4,5,5,5-pentafluoropentylsufinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol and process for the preparation thereof
SG176929A1 (en) 2009-06-18 2012-01-30 Abbott Lab Stable nanoparticulate drug suspension
EP2417975A4 (en) * 2009-08-31 2012-11-14 Xi An Libang Medical Technology Co Ltd FULVESTRANT NANOPERLENES / MICROPERLES AND MANUFACTURING METHOD AND USE
WO2012021791A2 (en) 2010-08-13 2012-02-16 Scidose Llc Aqueous formulation with improved stability
EP2468258A1 (en) 2010-12-22 2012-06-27 LEK Pharmaceuticals d.d. Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient
WO2012094620A2 (en) 2011-01-09 2012-07-12 Anp Technologies, Inc. Hydrophobic molecule-induced branched polymer aggregates and their use
ES2708302T3 (es) * 2011-05-20 2019-04-09 Capital Business Y Gestion De Finanzas S L Composición farmacéutica
CN102915088A (zh) 2011-08-03 2013-02-06 鸿富锦精密工业（深圳）有限公司 资料存储器固定装置
US11179468B2 (en) * 2012-04-09 2021-11-23 Eagle Pharmaceuticals, Inc. Fulvestrant formulations
ES2983451T3 (es) 2012-04-09 2024-10-23 Eagle Pharmaceuticals Inc Formulaciones de Fulvestrant
EP2858666B1 (en) * 2012-06-08 2019-09-04 F.Hoffmann-La Roche Ag Mutant selectivity and combinations of a phosphoinositide 3 kinase inhibitor compound and chemotherapeutic agents for the treatment of cancer
CN104337761B (zh) * 2013-08-07 2019-03-26 江苏豪森药业集团有限公司 氟维司群药物组合物
JP2016529308A (ja) * 2013-09-06 2016-09-23 サラー ウッディン アハメド， フルベストラント組成物
JP2016536282A (ja) * 2013-10-03 2016-11-24 ミレニアム ファーマシューティカルズ， インコーポレイテッドＭｉｌｌｅｎｎｉｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． ＰＩ３Ｋα阻害剤を使用する強化された治療レジメン
HUP1300646A2 (en) 2013-11-12 2015-05-28 Druggability Technologies Ip Holdco Jersey Ltd Complexes of fulvestrant and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them
PT107433B (pt) 2014-01-28 2018-12-04 Hovione Farm S A Processo de redução e controlo do tamanho de partícula
US9271990B2 (en) 2014-02-14 2016-03-01 Fresenius Kabi Usa, Llc Fulvestrant formulations
EP3164111B1 (en) 2014-07-02 2019-04-03 The Research Foundation for the State University of New York Surfactant-stripped micelle compositions with high cargo to surfactant ratio
WO2015018380A2 (en) 2014-07-03 2015-02-12 Cspc Zhongqi Pharmaceutical Technology(Shijiazhuang)Co., Ltd. Therapeutic nanoparticles and the preparation methods thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6774122B2 (en) * 2000-01-10 2004-08-10 Astrazeneca Ab Formulation
US20030114430A1 (en) * 2000-05-15 2003-06-19 Macleod Steven K. Stabilized injectable suspension of a steroidal drug
EP2460539A1 (en) * 2009-07-31 2012-06-06 Xi'an Libang Medical Technology Co., Ltd. Nanosphere or microsphere drug carrier, preparation method, composition and use thereof
WO2012035516A1 (en) * 2010-09-16 2012-03-22 Henk Swart Fulvestrant compositions and methods of use

Also Published As

Publication number Publication date
KR20190005183A (ko) 2019-01-15
CO2018013257A2 (es) 2018-12-28
NZ747911A (en) 2025-03-28
ZA201807031B (en) 2023-10-25
AU2017261321A1 (en) 2018-11-15
AU2017261321B2 (en) 2023-03-09
JP7312523B2 (ja) 2023-07-21
CA3022834A1 (en) 2017-11-09
IL285928A (en) 2021-10-31
RU2018142068A (ru) 2020-06-08
EP3452011A1 (en) 2019-03-13
CN109310621A (zh) 2019-02-05
US12370199B2 (en) 2025-07-29
MX2018013414A (es) 2019-06-06
UA125514C2 (uk) 2022-04-13
JP2023109959A (ja) 2023-08-08
US20190134059A1 (en) 2019-05-09
KR102438425B1 (ko) 2022-09-01
AU2023203392A1 (en) 2023-06-29
IL262465A (en) 2018-12-31
RU2018142068A3 (OSRAM) 2020-09-17
JP2019516789A (ja) 2019-06-20
MX2022013199A (es) 2022-12-13
JP2021169510A (ja) 2021-10-28
US20210346396A1 (en) 2021-11-11
IL285928B1 (en) 2025-02-01
MY205661A (en) 2024-11-04
MA44862A (fr) 2019-03-13
WO2017193048A1 (en) 2017-11-09
BR112018072768A2 (pt) 2019-02-19

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