MX2020004792A - Formulaciones de fulvestrant y metodos de su uso. - Google Patents

Formulaciones de fulvestrant y metodos de su uso.

Info

Publication number
MX2020004792A
MX2020004792A MX2020004792A MX2020004792A MX2020004792A MX 2020004792 A MX2020004792 A MX 2020004792A MX 2020004792 A MX2020004792 A MX 2020004792A MX 2020004792 A MX2020004792 A MX 2020004792A MX 2020004792 A MX2020004792 A MX 2020004792A
Authority
MX
Mexico
Prior art keywords
microns
alkyl
methods
soluble excipient
water
Prior art date
Application number
MX2020004792A
Other languages
English (en)
Inventor
Rama Abu Shmeis
Michael Joyce
Feng- Jing Chen
Steven L Krill
Adrian Hepner
Charles Wescott
Tara Jaskowski
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=64650494&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2020004792(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eagle Pharmaceuticals Inc filed Critical Eagle Pharmaceuticals Inc
Publication of MX2020004792A publication Critical patent/MX2020004792A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds 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
    • A61K31/566Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures 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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (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 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.
MX2020004792A 2017-11-08 2018-11-08 Formulaciones de fulvestrant y metodos de su uso. MX2020004792A (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
MX2020004792A true MX2020004792A (es) 2020-08-13

Family

ID=64650494

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2020004792A MX2020004792A (es) 2017-11-08 2018-11-08 Formulaciones de fulvestrant y metodos de su uso.
MX2024010323A MX2024010323A (es) 2017-11-08 2020-07-13 Formulaciones de fulvestrant y metodos de su uso

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2024010323A MX2024010323A (es) 2017-11-08 2020-07-13 Formulaciones de fulvestrant y metodos de su uso

Country Status (16)

Country Link
US (1) US12186427B2 (es)
EP (1) EP3706719A1 (es)
JP (1) JP7220712B2 (es)
KR (1) KR102670293B1 (es)
CN (1) CN111479556B (es)
AU (1) AU2018366212B2 (es)
BR (1) BR112020009141A2 (es)
CA (1) CA3082193A1 (es)
CO (1) CO2020006951A2 (es)
IL (1) IL274433B2 (es)
MA (1) MA50570A (es)
MX (2) MX2020004792A (es)
MY (1) MY204442A (es)
UA (1) UA128158C2 (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
EP4074304A4 (en) * 2019-12-11 2024-01-10 Shanghai Bocimed Pharmaceutical Co., Ltd. PHARMACEUTICAL COMPOSITION OF FULVESTRANT, PREPARATION METHOD AND APPLICATION THEREOF
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
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

Family Cites Families (20)

* 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
EP1778187B1 (en) 2004-08-04 2012-05-23 Camurus Ab Compositions forming non-lamellar dispersions
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
CN101244029A (zh) * 2006-03-28 2008-08-20 济南康泉医药科技有限公司 含雌激素受体拮抗剂的抗癌缓释注射剂
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
CN101525364B (zh) 2008-03-07 2012-12-12 杭州九源基因工程有限公司 一种氟维司群的晶型及其制备方法
WO2011022861A1 (zh) 2009-08-31 2011-03-03 西安力邦医药科技有限责任公司 氟维司群纳米球/微球及其制备方法和用途
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
NZ609420A (en) 2010-09-16 2015-06-26 Shimoda Biotech Pty Ltd Fulvestrant compositions and methods of use
BR112013029758A2 (pt) 2011-05-20 2018-10-09 Capital, Business Y Gestion De Finanzas S.L. composição farmacêutica
CA2869377C (en) * 2012-04-09 2022-11-08 Scidose, Llc Fulvestrant formulations
KR101915942B1 (ko) 2012-06-08 2018-11-06 에프. 호프만-라 로슈 아게 암의 치료를 위한 포스포이노시타이드 3 키나제 억제제 화합물 및 화학치료제의 돌연변이체 선택성 및 조합물
EP2999260B1 (en) * 2013-07-08 2018-08-29 Huawei Technologies Co., Ltd. Control method, device and system for video playing
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
WO2015033302A2 (en) * 2013-09-06 2015-03-12 Salah Uddin Ahmed Fulvestrant compositions
IL285928B2 (en) 2016-05-06 2025-06-01 Eagle Pharmaceuticals Inc Fulvestrant formulations and methods of their use
US11590077B2 (en) * 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use

Also Published As

Publication number Publication date
IL274433A (en) 2020-06-30
IL274433B1 (en) 2024-03-01
MY204442A (en) 2024-08-28
BR112020009141A2 (pt) 2020-10-27
RU2020118559A (ru) 2021-12-08
UA128158C2 (uk) 2024-04-24
KR102670293B1 (ko) 2024-05-30
AU2018366212A1 (en) 2020-05-14
JP2021502362A (ja) 2021-01-28
CN111479556A (zh) 2020-07-31
AU2018366212B2 (en) 2024-06-20
CN111479556B (zh) 2023-09-01
MA50570A (fr) 2020-09-16
IL274433B2 (en) 2024-07-01
JP7220712B2 (ja) 2023-02-10
EP3706719A1 (en) 2020-09-16
CA3082193A1 (en) 2019-05-16
MX2024010323A (es) 2025-02-10
WO2019094650A1 (en) 2019-05-16
US12186427B2 (en) 2025-01-07
ZA202002897B (en) 2023-10-25
KR20200085809A (ko) 2020-07-15
RU2020118559A3 (es) 2021-12-08
CO2020006951A2 (es) 2020-06-19
US20230404918A1 (en) 2023-12-21

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