BR112018072768A2 - suspensão, composição farmacêutica, método para formar uma suspensão fulvestrant aquosa, suspensão fulvestrant aquosa e método para tratar um indivíduo tendo câncer de mama - Google Patents

suspensão, composição farmacêutica, método para formar uma suspensão fulvestrant aquosa, suspensão fulvestrant aquosa e método para tratar um indivíduo tendo câncer de mama

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Publication number
BR112018072768A2
BR112018072768A2 BR112018072768-7A BR112018072768A BR112018072768A2 BR 112018072768 A2 BR112018072768 A2 BR 112018072768A2 BR 112018072768 A BR112018072768 A BR 112018072768A BR 112018072768 A2 BR112018072768 A2 BR 112018072768A2
Authority
BR
Brazil
Prior art keywords
suspension
microns
aqueous fulvestrant
treating
individual
Prior art date
Application number
BR112018072768-7A
Other languages
English (en)
Inventor
Chen Feng-Jing
L. Krill Steven
Abu Shmeis Rama
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 BR112018072768A2 publication Critical patent/BR112018072768A2/pt

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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
    • A61K31/56—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
    • 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
    • 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

Abstract

a descrição é dirigida a formulações fulvestrant incluindo suspensões de partículas fulvestrant apropriadas para injeção. as formulações podem compreender partículas fulvestrant tendo um ld dv(10) menor que cerca de 3 micra, por exemplo, entre cerca de 1 mícron a cerca de 3 micra, um ld dv(50) menor que cerca de 35 micra, por exemplo, entre cerca de 2 micra e cerca de 35 micra, e um ld dv(90) menor que cerca de 120 micra, por exemplo, entre cerca de 4 micra e cerca de 120 micra. as formulações podem compreender partículas fulvestrant tendo um ce dv(90) menor que cerca de 200 micra, por exemplo, entre cerca de 10 micra e cerca de 200 micra, um ce dv(50) menor que cerca de 60 micra, por exemplo, entre cerca de 5 micra e cerca de 60 micra, e um ce dv(10) menor que cerca de 25 micra, por exemplo, entre cerca de 1 mícron e cerca de 25 micra.
BR112018072768-7A 2016-05-06 2017-05-05 suspensão, composição farmacêutica, método para formar uma suspensão fulvestrant aquosa, suspensão fulvestrant aquosa e método para tratar um indivíduo tendo câncer de mama BR112018072768A2 (pt)

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
BR112018072768A2 true BR112018072768A2 (pt) 2019-02-19

Family

ID=58709642

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018072768-7A BR112018072768A2 (pt) 2016-05-06 2017-05-05 suspensão, composição farmacêutica, método para formar uma suspensão fulvestrant aquosa, suspensão fulvestrant aquosa e método para tratar um indivíduo tendo câncer de mama

Country Status (15)

Country Link
US (2) US20190134059A1 (pt)
EP (1) EP3452011A1 (pt)
JP (3) JP2019516789A (pt)
KR (1) KR102438425B1 (pt)
CN (1) CN109310621A (pt)
AU (2) AU2017261321B2 (pt)
BR (1) BR112018072768A2 (pt)
CA (1) CA3022834A1 (pt)
CO (1) CO2018013257A2 (pt)
IL (2) IL262465A (pt)
MA (1) MA44862A (pt)
MX (2) MX2018013414A (pt)
UA (1) UA125514C2 (pt)
WO (1) WO2017193048A1 (pt)
ZA (1) ZA201807031B (pt)

Families Citing this family (6)

* 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
WO2019094650A1 (en) * 2017-11-08 2019-05-16 Eagle Pharmaceuticals, Inc Fulvestrant formulations and methods of their use
JP2023504867A (ja) * 2019-12-11 2023-02-07 上海博志研新薬物技術有限公司 フルベストラント医薬組成物、その調製方法及び応用
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
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

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Also Published As

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

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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]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]