CO2020006951A2 - Formulaciones de fulvestrant y métodos de su uso - Google Patents

Formulaciones de fulvestrant y métodos de su uso

Info

Publication number
CO2020006951A2
CO2020006951A2 CONC2020/0006951A CO2020006951A CO2020006951A2 CO 2020006951 A2 CO2020006951 A2 CO 2020006951A2 CO 2020006951 A CO2020006951 A CO 2020006951A CO 2020006951 A2 CO2020006951 A2 CO 2020006951A2
Authority
CO
Colombia
Prior art keywords
microns
fulvestrant
methods
soluble excipient
water
Prior art date
Application number
CONC2020/0006951A
Other languages
English (en)
Inventor
Feng-Jing Chen
Steven L Krill
Rama Abu Shmeis
Adrian Hepner
Charles Wescott
Tara Jaskowski
Michael Joyce
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 CO2020006951A2 publication Critical patent/CO2020006951A2/es

Links

Classifications

    • 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
    • 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
    • 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
    • A61K31/566—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 having an oxo group in position 17, e.g. estrone
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente descripción proporciona métodos de tratamiento del cáncer de mama que incluyen la administración de suspensiones acuosas que comprenden fulvestrant solubilizado, partículas de fulvestrant no solubilizadas que tienen uno o más de un LD Dv(10) entre aproximadamente 1.5 y aproximadamente 2.1 micrómetros, un LD Dv(50) entre aproximadamente 5.5 y aproximadamente 9.0 micrómetros y un LD (Dv) entre aproximadamente 15 y aproximadamente 35 micrómetros, con la suspensión acuosa incluyendo además un tensoactivo, una polivinilpirrolidona y un alcohol de azúcar y un excipiente soluble en agua. El excipiente soluble en agua puede ser un aril-alquil de C1-6-OH un alquil de C1-6-OH, una sal amortiguadora, un polisorbato, un polialquilenglicol, un alquilenglicol de C1-12, una fosfatidilcolina o una combinación de los mismos.
CONC2020/0006951A 2017-11-08 2020-06-05 Formulaciones de fulvestrant y métodos de su uso CO2020006951A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762583403P 2017-11-08 2017-11-08
PCT/US2018/059906 WO2019094650A1 (en) 2017-11-08 2018-11-08 Fulvestrant formulations and methods of their use

Publications (1)

Publication Number Publication Date
CO2020006951A2 true CO2020006951A2 (es) 2020-06-19

Family

ID=64650494

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2020/0006951A CO2020006951A2 (es) 2017-11-08 2020-06-05 Formulaciones de fulvestrant y métodos de su uso

Country Status (13)

Country Link
US (1) US20230404918A1 (es)
EP (1) EP3706719A1 (es)
JP (1) JP7220712B2 (es)
KR (1) KR102670293B1 (es)
CN (1) CN111479556B (es)
BR (1) BR112020009141A2 (es)
CA (1) CA3082193A1 (es)
CO (1) CO2020006951A2 (es)
IL (1) IL274433B1 (es)
MA (1) MA50570A (es)
MX (1) MX2020004792A (es)
WO (1) WO2019094650A1 (es)
ZA (1) ZA202002897B (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20220370359A1 (en) * 2019-12-11 2022-11-24 Shanghai Bocimed Pharmaceutical Co., Ltd. Fulvestrant pharmaceutical composition, preparation method therefor, and application thereof
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
WO2023121232A1 (ko) * 2021-12-20 2023-06-29 주식회사 삼양홀딩스 용해도가 개선된 풀베스트란트의 약학 조성물 및 그 제조 방법

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0000313D0 (en) * 2000-01-10 2000-03-01 Astrazeneca Uk Ltd Formulation
US6495534B2 (en) * 2000-05-15 2002-12-17 Pharmacia & Upjohn Spa Stabilized aqueous suspensions for parenteral use
PL367624A1 (en) * 2001-07-07 2005-03-07 Astrazeneca Ab Pharmaceutical formulation for the intramuscular administration of fulvestrant
JP2006089386A (ja) * 2004-09-21 2006-04-06 Nippon Tenganyaku Kenkyusho:Kk ステロイドまたはステロイド誘導体を含有する懸濁性医薬組成物
CN1857217A (zh) * 2006-03-28 2006-11-08 济南康泉医药科技有限公司 一种含雌激素受体拮抗剂的抗癌缓释注射剂
US9180088B2 (en) * 2008-03-07 2015-11-10 Scidose, Llc Fulvestrant formulations
JP5675803B2 (ja) * 2009-07-31 2015-02-25 シーアン リーバン メディカル テクノロジー シーオー．， エルティーディーＸｉ’Ａｎ Ｌｉｂａｎｇ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ Ｃｏ．， Ｌｔｄ ミクロスフェア薬物担体、調製方法、組成物及びその使用
US9724355B2 (en) * 2010-09-16 2017-08-08 Shimoda Biotech (Pty) Ltd Fulvestrant compositions and methods of use
EP2836199B1 (en) * 2012-04-09 2024-06-19 Eagle Pharmaceuticals, Inc. Fulvestrant formulations
NZ702244A (en) * 2012-06-08 2017-06-30 Hoffmann La Roche Mutant selectivity and combinations of a phosphoinositide 3 kinase inhibitor compound and chemotherapeutic agents for the treatment of cancer
CN104782169B (zh) * 2013-07-08 2019-06-28 华为技术有限公司 视频播放的控制方法、设备及系统
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
AU2017261321B2 (en) * 2016-05-06 2023-03-09 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use

Also Published As

Publication number Publication date
CN111479556A (zh) 2020-07-31
JP2021502362A (ja) 2021-01-28
AU2018366212A1 (en) 2020-05-14
KR20200085809A (ko) 2020-07-15
KR102670293B1 (ko) 2024-05-30
MX2020004792A (es) 2020-08-13
RU2020118559A (ru) 2021-12-08
EP3706719A1 (en) 2020-09-16
WO2019094650A1 (en) 2019-05-16
CN111479556B (zh) 2023-09-01
BR112020009141A2 (pt) 2020-10-27
IL274433A (en) 2020-06-30
MA50570A (fr) 2020-09-16
CA3082193A1 (en) 2019-05-16
ZA202002897B (en) 2023-10-25
IL274433B1 (en) 2024-03-01
US20230404918A1 (en) 2023-12-21
RU2020118559A3 (es) 2021-12-08
JP7220712B2 (ja) 2023-02-10

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