CA3091546C - SPRAY DRYING PROCESS WITH CONTINUOUS PREPARATION OF A SPRAY SOLUTION - Google Patents

SPRAY DRYING PROCESS WITH CONTINUOUS PREPARATION OF A SPRAY SOLUTION

Info

Publication number
CA3091546C
CA3091546C CA3091546A CA3091546A CA3091546C CA 3091546 C CA3091546 C CA 3091546C CA 3091546 A CA3091546 A CA 3091546A CA 3091546 A CA3091546 A CA 3091546A CA 3091546 C CA3091546 C CA 3091546C
Authority
CA
Canada
Prior art keywords
process according
suspension
spray
solution
buffer tank
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA3091546A
Other languages
English (en)
French (fr)
Other versions
CA3091546A1 (en
Inventor
Joao Vicente
Clara Sa Couto
Rui Ferreira
Marcio Temtem
Original Assignee
Hovione Scientia Ltd
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 Hovione Scientia Ltd filed Critical Hovione Scientia Ltd
Publication of CA3091546A1 publication Critical patent/CA3091546A1/en
Application granted granted Critical
Publication of CA3091546C publication Critical patent/CA3091546C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate 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

Landscapes

  • 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)
CA3091546A 2018-02-22 2019-02-22 SPRAY DRYING PROCESS WITH CONTINUOUS PREPARATION OF A SPRAY SOLUTION Active CA3091546C (en)

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 (2)

Publication Number Publication Date
CA3091546A1 CA3091546A1 (en) 2019-08-29
CA3091546C true CA3091546C (en) 2024-11-12

Family

ID=65729388

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3091546A Active CA3091546C (en) 2018-02-22 2019-02-22 SPRAY DRYING PROCESS WITH CONTINUOUS PREPARATION OF A SPRAY SOLUTION

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

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US6555139B2 (en) * 1999-06-28 2003-04-29 Wockhardt Europe Limited Preparation of micron-size pharmaceutical particles by microfluidization
CL2004001884A1 (es) * 2003-08-04 2005-06-03 Pfizer Prod Inc Procedimiento de secado por pulverizacion para la formacion de dispersiones solidas amorfas de un farmaco y polimeros.
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
PT107846B (pt) * 2014-08-01 2019-03-22 Hovione Farm S A Produção de nano- partículas de dispersões sólidas amorfas por co-precipitação controlada
US9432572B2 (en) * 2014-12-01 2016-08-30 Here Global B.V. Method and apparatus for automatic prediction of dynamic exposure
PT108368B (pt) * 2015-03-31 2018-11-05 Hovione Farm S A Produção contínua de partículas
PT109117B (pt) * 2016-01-28 2019-02-01 Hovione Farm Sa Complexação de ingredientes ativos farmacêuticos
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

Also Published As

Publication number Publication date
CN111954520A (zh) 2020-11-17
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
AU2019224665B2 (en) 2024-09-05
JP7481259B2 (ja) 2024-05-10
KR102784679B1 (ko) 2025-03-21

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