DK3723760T3 - Ettrinsformalingsfremgangsmåde til fremstilling af mikroniserede paliperidonestere - Google Patents

Ettrinsformalingsfremgangsmåde til fremstilling af mikroniserede paliperidonestere

Info

Publication number
DK3723760T3
DK3723760T3 DK18889552.8T DK18889552T DK3723760T3 DK 3723760 T3 DK3723760 T3 DK 3723760T3 DK 18889552 T DK18889552 T DK 18889552T DK 3723760 T3 DK3723760 T3 DK 3723760T3
Authority
DK
Denmark
Prior art keywords
preparation
milling process
step milling
paliperidone esters
micronized paliperidone
Prior art date
Application number
DK18889552.8T
Other languages
English (en)
Inventor
Williams Sanders
Demin Liu
Baohua Yue
Original Assignee
SpecGx LLC
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 SpecGx LLC filed Critical SpecGx LLC
Application granted granted Critical
Publication of DK3723760T3 publication Critical patent/DK3723760T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • A61K9/16Agglomerates; 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
    • A61K9/1611Inorganic 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
    • A61K9/1629Organic 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B02CRUSHING, PULVERISING, OR DISINTEGRATING; PREPARATORY TREATMENT OF GRAIN FOR MILLING
    • B02CCRUSHING, PULVERISING, OR DISINTEGRATING IN GENERAL; MILLING GRAIN
    • B02C17/00Disintegrating by tumbling mills, i.e. mills having a container charged with the material to be disintegrated with or without special disintegrating members such as pebbles or balls
    • B02C17/16Mills in which a fixed container houses stirring means tumbling the charge
    • B02C17/168Mills in which a fixed container houses stirring means tumbling the charge with a basket media milling device arranged in or on the container, involving therein a circulatory flow of the material to be milled

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
DK18889552.8T 2017-12-14 2018-12-13 Ettrinsformalingsfremgangsmåde til fremstilling af mikroniserede paliperidonestere DK3723760T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762598827P 2017-12-14 2017-12-14
PCT/US2018/065443 WO2019118722A1 (en) 2017-12-14 2018-12-13 One step milling process for preparing micronized paliperidone esters

Publications (1)

Publication Number Publication Date
DK3723760T3 true DK3723760T3 (da) 2025-08-25

Family

ID=66815477

Family Applications (1)

Application Number Title Priority Date Filing Date
DK18889552.8T DK3723760T3 (da) 2017-12-14 2018-12-13 Ettrinsformalingsfremgangsmåde til fremstilling af mikroniserede paliperidonestere

Country Status (12)

Country Link
US (1) US20190183896A1 (da)
EP (1) EP3723760B1 (da)
JP (1) JP2021506757A (da)
AU (1) AU2018383636B2 (da)
CA (1) CA3084002A1 (da)
DK (1) DK3723760T3 (da)
ES (1) ES3037855T3 (da)
HU (1) HUE073135T2 (da)
MX (1) MX2020005816A (da)
PL (1) PL3723760T3 (da)
PT (1) PT3723760T (da)
WO (1) WO2019118722A1 (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10987303B2 (en) 2018-05-02 2021-04-27 LifeMax Laboratories, Inc. Extended release suspension formulation of lurasidone
CN110279659A (zh) * 2019-07-08 2019-09-27 华裕(无锡)制药有限公司 棕榈酸帕利哌酮制剂及其制备方法
KR102794804B1 (ko) * 2020-11-30 2025-04-10 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법
ES2981035T3 (es) 2020-11-30 2024-10-07 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada
MX2023006370A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
WO2023030870A1 (en) * 2021-08-30 2023-03-09 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5994041A (en) * 1985-04-06 1999-11-30 Eastman Kodak Company Process for buffering concentrated aqueous slurries
US5902711A (en) * 1997-06-25 1999-05-11 Eastman Kodak Company Method to media mill particles using crosslinked polymer media and organic solvent
UA72189C2 (uk) * 1997-11-17 2005-02-15 Янссен Фармацевтика Н.В. Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот
KR100786927B1 (ko) * 2000-06-28 2007-12-17 스미스클라인비이참피이엘시이 습식 분쇄방법
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
CA3014788A1 (en) * 2016-02-17 2017-08-24 Alkermes Pharma Ireland Limited Compositions of multiple aripiprazole prodrugs
CN106137985B (zh) * 2016-08-04 2019-03-08 齐鲁制药有限公司 一种稳定的棕榈酸帕利哌酮长效制剂

Also Published As

Publication number Publication date
CA3084002A1 (en) 2019-06-20
EP3723760A4 (en) 2021-10-13
ES3037855T3 (en) 2025-10-08
PL3723760T3 (pl) 2025-10-20
JP2021506757A (ja) 2021-02-22
WO2019118722A1 (en) 2019-06-20
EP3723760A1 (en) 2020-10-21
PT3723760T (pt) 2025-08-05
HUE073135T2 (hu) 2026-01-28
AU2018383636B2 (en) 2024-01-18
US20190183896A1 (en) 2019-06-20
EP3723760B1 (en) 2025-06-11
AU2018383636A1 (en) 2020-06-18
BR112020011614A2 (pt) 2020-12-08
MX2020005816A (es) 2020-08-20

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