CN107205931A - 通过共沉淀制备亚微米级别的无定形固体分散体的方法 - Google Patents

通过共沉淀制备亚微米级别的无定形固体分散体的方法 Download PDF

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Publication number
CN107205931A
CN107205931A CN201580051675.1A CN201580051675A CN107205931A CN 107205931 A CN107205931 A CN 107205931A CN 201580051675 A CN201580051675 A CN 201580051675A CN 107205931 A CN107205931 A CN 107205931A
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solvent
pharmaceutically active
active compound
solution
fluid
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Chinese (zh)
Inventor
M·泰姆泰姆
R·佩雷拉
J·维森特
F·加斯珀
I·杜阿尔特
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Hovione International Ltd
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Hovione International Ltd
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    • 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
    • A61K9/146—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 macromolecular compounds
    • 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
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/16—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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J13/00—Colloid chemistry, e.g. the production of colloidal materials or their solutions, not otherwise provided for; Making microcapsules or microballoons
    • B01J13/0004—Preparation of sols
    • B01J13/0008—Sols of inorganic materials in water
    • B01J13/0013—Sols of inorganic materials in water from a precipitate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/0093—Microreactors, e.g. miniaturised or microfabricated reactors

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201580051675.1A 2014-08-01 2015-07-31 通过共沉淀制备亚微米级别的无定形固体分散体的方法 Pending CN107205931A (zh)

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PT107846 2014-08-01
PT10784614A PT107846B (pt) 2014-08-01 2014-08-01 Produção de nano- partículas de dispersões sólidas amorfas por co-precipitação controlada
PCT/GB2015/052233 WO2016016665A1 (en) 2014-08-01 2015-07-31 A method of preparing amorphous solid dispersion in submicron range by co-precipitation

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CN202310736034.6A Pending CN117159474A (zh) 2014-08-01 2015-07-31 通过共沉淀制备亚微米级别的无定形固体分散体的方法

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US (1) US20170209372A1 (https=)
EP (1) EP3174528A1 (https=)
JP (4) JP2017523205A (https=)
CN (2) CN107205931A (https=)
AU (1) AU2015295073B2 (https=)
CA (1) CA2956732C (https=)
IL (1) IL250372A0 (https=)
PT (1) PT107846B (https=)
WO (1) WO2016016665A1 (https=)

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CN110693839A (zh) * 2019-11-19 2020-01-17 乐普药业股份有限公司 一种甲磺酸仑伐替尼固体分散体及其制备方法和用途
WO2021072635A1 (zh) * 2019-10-15 2021-04-22 诸暨易联众创企业管理服务有限公司 一种棒状氯化亚铁纳米材料的制备方法
WO2021134647A1 (zh) * 2019-12-31 2021-07-08 广州帝奇医药技术有限公司 一种持续释放组合物及其制备方法
CN120919059A (zh) * 2025-10-15 2025-11-11 浙江奥翔药业股份有限公司 一种芦可替尼药物组合物

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CN105963257B (zh) * 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN105878190B (zh) * 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 缓释微粒的制备方法、制得的缓释微粒及其应用
CN105963258B (zh) * 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
CN105878191B (zh) * 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 缓释微粒的制备方法、制得的缓释微粒及其应用
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CN113573712A (zh) 2019-02-18 2021-10-29 斯莱班克制药有限责任公司 尼洛替尼的药物组合物
WO2021064123A1 (en) * 2019-10-03 2021-04-08 Synthon B.V. Pharmaceutical composition comprising enzalutamide
JP7378279B2 (ja) * 2019-11-18 2023-11-13 日本化薬株式会社 ニロチニブを有効成分とする医薬錠剤及びその製造方法
CN112933049B (zh) * 2019-11-26 2024-02-06 深圳微芯生物科技股份有限公司 含无定型态芳杂环化合物的组合物、其制备方法及用途
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CN112121014A (zh) * 2020-08-19 2020-12-25 汕尾市前瞻高等理工研究院 一种制备稳定无定型药物固体制剂的方法
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021072635A1 (zh) * 2019-10-15 2021-04-22 诸暨易联众创企业管理服务有限公司 一种棒状氯化亚铁纳米材料的制备方法
CN110693839A (zh) * 2019-11-19 2020-01-17 乐普药业股份有限公司 一种甲磺酸仑伐替尼固体分散体及其制备方法和用途
CN110693839B (zh) * 2019-11-19 2022-03-08 乐普药业股份有限公司 一种甲磺酸仑伐替尼固体分散体及其制备方法和用途
WO2021134647A1 (zh) * 2019-12-31 2021-07-08 广州帝奇医药技术有限公司 一种持续释放组合物及其制备方法
CN120919059A (zh) * 2025-10-15 2025-11-11 浙江奥翔药业股份有限公司 一种芦可替尼药物组合物

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WO2016016665A1 (en) 2016-02-04
JP2023012459A (ja) 2023-01-25
US20170209372A1 (en) 2017-07-27
AU2015295073B2 (en) 2019-12-19
JP2017523205A (ja) 2017-08-17
PT107846B (pt) 2019-03-22
CA2956732C (en) 2022-11-22
CA2956732A1 (en) 2016-02-04
EP3174528A1 (en) 2017-06-07
CN117159474A (zh) 2023-12-05
AU2015295073A1 (en) 2017-02-23
PT107846A (pt) 2016-02-01

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