MX2022013199A - Formulaciones de fulvestrant y metodos para su uso. - Google Patents

Formulaciones de fulvestrant y metodos para su uso.

Info

Publication number
MX2022013199A
MX2022013199A MX2022013199A MX2022013199A MX2022013199A MX 2022013199 A MX2022013199 A MX 2022013199A MX 2022013199 A MX2022013199 A MX 2022013199A MX 2022013199 A MX2022013199 A MX 2022013199A MX 2022013199 A MX2022013199 A MX 2022013199A
Authority
MX
Mexico
Prior art keywords
microns
less
methods
formulations
fulvestrant
Prior art date
Application number
MX2022013199A
Other languages
English (en)
Inventor
Rama Abu Shmeis
Steven L Krill
Feng-Jing Chen
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 MX2022013199A publication Critical patent/MX2022013199A/es

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
    • A61K31/56—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
    • 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
    • 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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (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)

Abstract

La divulgación está dirigida a formulaciones de fulvestrant que incluyen suspensiones de partículas de fulvestrant adecuadas para inyección. Las formulaciones pueden comprender partículas de fulvestrant que tienen un LD Dv(10) de menos de alrededor de 3 micrones, por ejemplo, entre alrededor de 1 micrón y alrededor de 3 micrones, un LD Dv(50) de menos de alrededor de 35 micrones, por ejemplo, entre alrededor de 2 micrones y alrededor de 35 micrones, y un LD Dv(90) inferior a alrededor de 120 micrones, por ejemplo, entre alrededor de 4 micrones y alrededor de 120 micrones. Las formulaciones pueden comprender partículas de fulvestrant que tienen un CE Dv(90) inferior a alrededor de 200 micrones, por ejemplo, entre alrededor de 10 micrones y alrededor de 200 micrones, un CE Dv(50) inferior a alrededor de 60 micrones, por ejemplo, entre alrededor de 5 micrones y alrededor de 60 micrones, y un CE Dv(10) inferior a alrededor de 25 micrones, por ejemplo, entre alrededor de 1 micrón y alrededor de 25 micrones.
MX2022013199A 2016-05-06 2018-11-01 Formulaciones de fulvestrant y metodos para su uso. MX2022013199A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662332842P 2016-05-06 2016-05-06
US201662420555P 2016-11-10 2016-11-10

Publications (1)

Publication Number Publication Date
MX2022013199A true MX2022013199A (es) 2022-12-13

Family

ID=58709642

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2018013414A MX2018013414A (es) 2016-05-06 2017-05-05 Formulaciones de fulvestrant y metodos para su uso.
MX2022013199A MX2022013199A (es) 2016-05-06 2018-11-01 Formulaciones de fulvestrant y metodos para su uso.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2018013414A MX2018013414A (es) 2016-05-06 2017-05-05 Formulaciones de fulvestrant y metodos para su uso.

Country Status (15)

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

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
JP7220712B2 (ja) * 2017-11-08 2023-02-10 イーグル ファーマスーティカルズ、インク． フルベストラント製剤とその使用方法
US20220370359A1 (en) * 2019-12-11 2022-11-24 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
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

Family Cites Families (19)

* 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
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
GB0116619D0 (en) * 2001-07-07 2001-08-29 Astrazeneca Ab Formulation
PL367624A1 (en) * 2001-07-07 2005-03-07 Astrazeneca Ab Pharmaceutical formulation for the intramuscular administration of fulvestrant
WO2006013369A2 (en) * 2004-08-04 2006-02-09 Camurus Ab Compositions forming non-lamellar dispersions
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
WO2009111057A2 (en) * 2008-03-07 2009-09-11 Scidose Llc 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
JP2012530704A (ja) * 2009-06-18 2012-12-06 アボット・ラボラトリーズ 安定なナノ粒子状薬物懸濁液
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
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
WO2012035516A1 (en) 2010-09-16 2012-03-22 Henk Swart Fulvestrant compositions and methods of use
BR112013029758A2 (pt) * 2011-05-20 2018-10-09 Capital, Business Y Gestion De Finanzas S.L. composição farmacêutica
US11179468B2 (en) 2012-04-09 2021-11-23 Eagle Pharmaceuticals, Inc. Fulvestrant formulations
CA2871359A1 (en) 2012-06-08 2013-12-12 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
US20160213682A1 (en) * 2013-09-06 2016-07-28 Salah Uddin Ahmed Fulvestrant compositions
WO2015051193A1 (en) * 2013-10-03 2015-04-09 Millennium Pharmaceuticals, Inc. ENHANCED TREATMENT REGIMENS USING PI3Kα INHIBITORS

Also Published As

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

Similar Documents

Publication Publication Date Title
MX2022013199A (es) Formulaciones de fulvestrant y metodos para su uso.
MX2023008559A (es) Proteínas de fusión fc heterodiméricas il15/il15ra.
EP4335874A3 (en) Anti-hla-g antibodies and use thereof
MY191169A (en) Anti-fcrh5 antibodies
TWD208426S (zh) 鼻管組合及其配件
MY195442A (en) Anti-CD40 Antibodies and Their Uses
MX2020009461A (es) Anticuerpos anti-proteína que contiene dominio de inmunologlubina rfig elacionado con el receptor de poliovirus (pvrig) y métodos de uso.
PH12016501186A1 (en) Anti-cd3 antibodies and methods of use
MY186334A (en) Anti-her2 antibodies and immunoconjugates
WO2017132580A3 (en) Split inteins with exceptional splicing activity
SG10201804931QA (en) Anti-cll-1 antibodies and immunoconjugates
EP4292600A3 (en) Photoreceptors and photoreceptor progenitors produced from pluripotent stem cells
MX2020010951A (es) Anticuerpos anti-hla-g y utilizacion de los mismos.
WO2016061389A3 (en) Anti-alpha-synuclein antibodies and methods of use
WO2018081648A8 (en) ANTI-MIC ANTIBODIES AND METHODS OF USE
SG10201808259TA (en) Anti-jagged1 antibodies and methods of use
MX2017004617A (es) Variantes estabilizadas de alfa amilasa y su uso.
AU2014233478A8 (en) Anti-CD25 antibodies and their uses
MX2019005322A (es) Composiciones de recubrimiento y metodos de uso de las mismas.
AU2017317563A8 (en) Detergent compositions comprising xanthan lyase variants I
WO2017091748A8 (en) Implantable objects, guiding devices, and methods of use thereof
MY194603A (en) Anti-Complement Factor Bb Antibodies And Uses Thereof
TWD189563S (zh) 鼻管組件
MX2020013269A (es) Inhibidores de la vía de respuesta al estrés integrada.
MY182267A (en) Polishing composition and polishing method