CN111954520A - 连续制备喷雾溶液的喷雾干燥方法 - Google Patents

连续制备喷雾溶液的喷雾干燥方法 Download PDF

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Publication number
CN111954520A
CN111954520A CN201980025054.4A CN201980025054A CN111954520A CN 111954520 A CN111954520 A CN 111954520A CN 201980025054 A CN201980025054 A CN 201980025054A CN 111954520 A CN111954520 A CN 111954520A
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China
Prior art keywords
suspension
component
spray
buffer tank
particles
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Pending
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CN201980025054.4A
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English (en)
Chinese (zh)
Inventor
J·维森特
C·萨库托
R·费雷拉
M·特姆特姆
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Hovione Scientia Ltd
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Hovione Scientia Ltd
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Publication of CN111954520A publication Critical patent/CN111954520A/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/146Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J19/00Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/0093Microreactors, e.g. miniaturised or microfabricated reactors
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/005Drying solid materials or objects by processes not involving the application of heat by dipping them into or mixing them with a chemical liquid, e.g. organic; chemical, e.g. organic, dewatering aids

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medicinal Preparation (AREA)
  • Glanulating (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201980025054.4A 2018-02-22 2019-02-22 连续制备喷雾溶液的喷雾干燥方法 Pending CN111954520A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PT110585 2018-02-22
PT110585A PT110585B (pt) 2018-02-22 2018-02-22 Processo de produção contínua de partículas compreendendo secagem por atomização com preparação contínua da solução de atomização
PCT/GB2019/050495 WO2019162688A1 (en) 2018-02-22 2019-02-22 A spray drying process with continuous preparation of spray solution

Publications (1)

Publication Number Publication Date
CN111954520A true CN111954520A (zh) 2020-11-17

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CN201980025054.4A Pending CN111954520A (zh) 2018-02-22 2019-02-22 连续制备喷雾溶液的喷雾干燥方法

Country Status (10)

Country Link
US (1) US11752105B2 (https=)
EP (1) EP3755307B1 (https=)
JP (1) JP7481259B2 (https=)
KR (1) KR102784679B1 (https=)
CN (1) CN111954520A (https=)
AU (1) AU2019224665B2 (https=)
CA (1) CA3091546C (https=)
IL (1) IL276826B2 (https=)
PT (1) PT110585B (https=)
WO (1) WO2019162688A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT110585B (pt) 2018-02-22 2021-04-22 Hovione Farmaciencia Sa Processo de produção contínua de partículas compreendendo secagem por atomização com preparação contínua da solução de atomização
US12466883B1 (en) 2024-05-13 2025-11-11 Lumen Bioscience, Inc. Leptin compositions and methods of making and using the same to support weight loss and/or maintenance
WO2026013055A1 (en) 2024-07-09 2026-01-15 Hovione Farmaciência S.A., Methods and systems for preparing feed solutions for spray drying

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020071870A1 (en) * 1999-06-28 2002-06-13 Vinay K. Sharma Preparation of micron-size pharmaceutical particles by microfluidization
US20050031692A1 (en) * 2003-08-04 2005-02-10 Pfizer Inc Spray drying processes for forming solid amorphous dispersions of drugs and polymers
WO2016156841A1 (en) * 2015-03-31 2016-10-06 Hovione Scientia Limited Continuous production of particles
US20170209372A1 (en) * 2014-08-01 2017-07-27 Hovione International Ltd A Method of Preparing Amorphous Solid Dispersion in Submicron Range by Co-Precipitation
WO2017129988A1 (en) * 2016-01-28 2017-08-03 Hovione Scientia Limited Continuous complexation of active pharmaceutical ingredients

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US5222807A (en) 1991-03-12 1993-06-29 Gaco Manufacturing Division Of Gaddis Petroleum Corporation Low shear polymer dissolution apparatus
FI98892C (fi) 1994-11-15 1997-09-10 Turun Asennusteam Oy Polymeerien liuotusmenetelmä ja -laite
CA2299284C (en) 1997-08-05 2008-07-08 Mfic Corporation Multiple stream high pressure mixer/reactor
ZA200905094B (en) * 2006-12-22 2010-09-29 Yuhan Corp Revaprazan-containing solid dispersion and process for the preparation thereof
US8187554B2 (en) 2008-04-23 2012-05-29 Microfluidics International Corporation Apparatus and methods for nanoparticle generation and process intensification of transport and reaction systems
WO2010111132A2 (en) 2009-03-27 2010-09-30 Bend Research, Inc. Spray-drying process
CN105142767B (zh) 2013-03-14 2017-12-12 艺康美国股份有限公司 聚合物溶解系统
KR20160120739A (ko) * 2014-02-11 2016-10-18 램 테라퓨틱스, 인코포레이티드 림프관평활근종증의 치료를 위한 라파마이신
PL3166986T3 (pl) * 2014-07-10 2023-07-31 Huntsman Petrochemical Llc Kompozycja zmniejszająca ilość aldehydów emitowanych z pianek poliuretanowych
US9432572B2 (en) * 2014-12-01 2016-08-30 Here Global B.V. Method and apparatus for automatic prediction of dynamic exposure
PT110585B (pt) 2018-02-22 2021-04-22 Hovione Farmaciencia Sa Processo de produção contínua de partículas compreendendo secagem por atomização com preparação contínua da solução de atomização

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020071870A1 (en) * 1999-06-28 2002-06-13 Vinay K. Sharma Preparation of micron-size pharmaceutical particles by microfluidization
US20050031692A1 (en) * 2003-08-04 2005-02-10 Pfizer Inc Spray drying processes for forming solid amorphous dispersions of drugs and polymers
US20170209372A1 (en) * 2014-08-01 2017-07-27 Hovione International Ltd A Method of Preparing Amorphous Solid Dispersion in Submicron Range by Co-Precipitation
WO2016156841A1 (en) * 2015-03-31 2016-10-06 Hovione Scientia Limited Continuous production of particles
WO2017129988A1 (en) * 2016-01-28 2017-08-03 Hovione Scientia Limited Continuous complexation of active pharmaceutical ingredients

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Publication number Publication date
WO2019162688A1 (en) 2019-08-29
IL276826B1 (en) 2024-10-01
CA3091546A1 (en) 2019-08-29
EP3755307A1 (en) 2020-12-30
IL276826A (en) 2020-10-29
EP3755307C0 (en) 2023-08-23
PT110585B (pt) 2021-04-22
KR20200123452A (ko) 2020-10-29
PT110585A (pt) 2019-08-22
EP3755307B1 (en) 2023-08-23
US20210077405A1 (en) 2021-03-18
US11752105B2 (en) 2023-09-12
IL276826B2 (en) 2025-02-01
AU2019224665A1 (en) 2020-11-26
JP2021514954A (ja) 2021-06-17
CA3091546C (en) 2024-11-12
AU2019224665B2 (en) 2024-09-05
JP7481259B2 (ja) 2024-05-10
KR102784679B1 (ko) 2025-03-21

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