CN113260353A - 氟维司群药物组合物、其制备方法及应用 - Google Patents

氟维司群药物组合物、其制备方法及应用 Download PDF

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Publication number
CN113260353A
CN113260353A CN202080007455.XA CN202080007455A CN113260353A CN 113260353 A CN113260353 A CN 113260353A CN 202080007455 A CN202080007455 A CN 202080007455A CN 113260353 A CN113260353 A CN 113260353A
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fulvestrant
microns
solid particles
injection
pharmaceutical composition
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CN202080007455.XA
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应述欢
李洪
陈志祥
王婷婷
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Shanghai Bocimed Pharmaceutical Co Ltd
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Shanghai Bocimed Pharmaceutical Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
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    • 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
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    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/547—Chelates, e.g. Gd-DOTA or Zinc-amino acid chelates; Chelate-forming compounds, e.g. DOTA or ethylenediamine being covalently linked or complexed to the pharmacologically- or therapeutically-active agent
    • 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
    • A61K9/10—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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Abstract

氟维司群药物组合物、其制备方法及应用。所述氟维司群药物组合物包括氟维司群固体粒子，其中所述的氟维司群固体粒子的粒径为Dv(10)选自0.400微米～6.000微米、Dv(50)选自0.700微米～6.000微米且Dv(90)选自1.000微米～6.000微米，条件是：Dv(10)不为0.400微米、Dv(50)不为0.700微米并且Dv(90)不为1.000微米。氟维司群药物组合物长效缓释，施用方便，给药体积减小，注射疼痛度大大降低，市场化前景良好。

Description

PCT国内申请，说明书已公开。

Claims (10)

  1. PCT国内申请，权利要求书已公开。
CN202080007455.XA 2019-12-11 2020-12-10 氟维司群药物组合物、其制备方法及应用 Pending CN113260353A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CN2019112625444 2019-12-11
CN201911262544 2019-12-11
CN202010590154 2020-06-24
CN2020105901546 2020-06-24
PCT/CN2020/135311 WO2021115389A1 (zh) 2019-12-11 2020-12-10 氟维司群药物组合物、其制备方法及应用

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CN113260353A true CN113260353A (zh) 2021-08-13

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US (1) US20220370359A1 (zh)
EP (1) EP4074304A4 (zh)
JP (1) JP2023504867A (zh)
CN (1) CN113260353A (zh)
WO (1) WO2021115389A1 (zh)

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KR20230094172A (ko) * 2021-12-20 2023-06-27 주식회사 삼양홀딩스 용해도가 개선된 풀베스트란트의 약학 조성물 및 그 제조 방법

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1553815A (zh) * 2001-07-07 2004-12-08 用于肌内给药的氟维司群药物制剂
CN109310621A (zh) * 2016-05-06 2019-02-05 伊格尔制药公司 氟维司群制剂和其使用方法
WO2019094650A1 (en) * 2017-11-08 2019-05-16 Eagle Pharmaceuticals, Inc Fulvestrant formulations and methods of their use

Family Cites Families (4)

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Publication number Priority date Publication date Assignee Title
GB0000313D0 (en) * 2000-01-10 2000-03-01 Astrazeneca Uk Ltd Formulation
EP2616078B1 (en) * 2010-09-16 2019-12-25 Shimoda Biotech (Pty) Ltd Fulvestrant compositions and methods of use
BR112014028376A2 (pt) * 2012-06-08 2018-04-24 Hoffmann La Roche métodos para o tratamento de um distúrbio hiperproliferativo, para a determinação dos compostos, para monitorar, para optimizar a eficácia terapêutica e de identificação de um biomarcador; formulação farmacêutica; utilização de uma combinação terapêutica e de gdc-0032, artigo de manufatura, produto e invenção
CN107789320B (zh) * 2016-08-31 2021-06-22 鲁南制药集团股份有限公司 一种氟维司群缓释注射液及其制备工艺

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1553815A (zh) * 2001-07-07 2004-12-08 用于肌内给药的氟维司群药物制剂
CN109310621A (zh) * 2016-05-06 2019-02-05 伊格尔制药公司 氟维司群制剂和其使用方法
WO2019094650A1 (en) * 2017-11-08 2019-05-16 Eagle Pharmaceuticals, Inc Fulvestrant formulations and methods of their use

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JP2023504867A (ja) 2023-02-07
EP4074304A4 (en) 2024-01-10
US20220370359A1 (en) 2022-11-24
WO2021115389A1 (zh) 2021-06-17

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