AU2019283550B2 - Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea - Google Patents

Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea Download PDF

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AU2019283550B2
AU2019283550B2 AU2019283550A AU2019283550A AU2019283550B2 AU 2019283550 B2 AU2019283550 B2 AU 2019283550B2 AU 2019283550 A AU2019283550 A AU 2019283550A AU 2019283550 A AU2019283550 A AU 2019283550A AU 2019283550 B2 AU2019283550 B2 AU 2019283550B2
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phenyl
cyclodextrin
triazin
dimorpholin
dimethylamino
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AU2019283550A1 (en
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Andrew Gilbert BRIGHT
James Joseph HUSSEY
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Pfizer Inc
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Pfizer Inc
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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
    • A61K9/08—Solutions
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • 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
    • A61K47/30—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
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2019283550A 2018-06-07 2019-06-04 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea Active AU2019283550B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022211854A AU2022211854B2 (en) 2018-06-07 2022-08-03 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201862681722P 2018-06-07 2018-06-07
US62/681,722 2018-06-07
US201862754651P 2018-11-02 2018-11-02
US62/754,651 2018-11-02
US201962796133P 2019-01-24 2019-01-24
US62/796,133 2019-01-24
US201962841882P 2019-05-02 2019-05-02
US62/841,882 2019-05-02
PCT/IB2019/054643 WO2019234632A1 (en) 2018-06-07 2019-06-04 Aqueous formulation comprising 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022211854A Division AU2022211854B2 (en) 2018-06-07 2022-08-03 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea

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AU2019283550A1 AU2019283550A1 (en) 2020-12-10
AU2019283550B2 true AU2019283550B2 (en) 2022-06-16

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AU2019283550A Active AU2019283550B2 (en) 2018-06-07 2019-06-04 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea
AU2022211854A Active AU2022211854B2 (en) 2018-06-07 2022-08-03 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea

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AU2022211854A Active AU2022211854B2 (en) 2018-06-07 2022-08-03 Aqueous formulation comprising 1-(4-{(4-(dimethylamino)piperidin-1-yl)carbonyl}phenyl)-3-(4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl)urea

Country Status (25)

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US (2) US12109308B2 (https=)
EP (3) EP4249069B1 (https=)
JP (2) JP7423200B2 (https=)
KR (2) KR20230142810A (https=)
CN (2) CN116270452A (https=)
AU (2) AU2019283550B2 (https=)
BR (1) BR112020023891A2 (https=)
CA (1) CA3102527A1 (https=)
DK (2) DK4249069T3 (https=)
ES (2) ES3057278T3 (https=)
FI (2) FI3810089T3 (https=)
HR (2) HRP20251602T1 (https=)
HU (1) HUE063493T2 (https=)
IL (1) IL279270A (https=)
LT (2) LT3810089T (https=)
MX (2) MX2020013238A (https=)
NZ (1) NZ805649A (https=)
PL (2) PL3810089T3 (https=)
PT (2) PT3810089T (https=)
RS (2) RS64692B1 (https=)
SG (1) SG11202011256RA (https=)
SI (2) SI4249069T1 (https=)
SM (2) SMT202300307T1 (https=)
TW (1) TWI696469B (https=)
WO (1) WO2019234632A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI3672571T1 (sl) 2017-08-25 2022-01-31 Pfizer Inc. Farmacevtska vodna raztopina, ki vsebuje 1-(4-((4-(dimetilamino) piperdin-1-il)karbonil)fenil)-3-(4-(4,6-dimorfolin-4-il-1,3, 5-triazin-2-il)fenil)sečnino
CA3227191A1 (en) 2021-07-26 2023-02-02 Celcuity Inc. 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer
WO2025128712A1 (en) 2023-12-12 2025-06-19 Celcuity Inc. Treatment of ocular diseases using 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl)phenyl)-3-[4-(4,6- dimorpholin-4- yl-1,3,5-triazin-2-yl)phenyl]urea
US20260053814A1 (en) 2024-08-21 2026-02-26 Celcuity Inc. Treatment regimens for gedatolisib in hormonally-driven disorders

Citations (1)

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WO2016097949A1 (en) * 2014-12-17 2016-06-23 Pfizer Inc. Formulations of a pi3k/mtor-inhibitor for intravenous administration

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US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
US5002935A (en) * 1987-12-30 1991-03-26 University Of Florida Improvements in redox systems for brain-targeted drug delivery
US5298410A (en) * 1993-02-25 1994-03-29 Sterling Winthrop Inc. Lyophilized formulation of polyethylene oxide modified proteins with increased shelf-life
WO2003015828A1 (en) * 2001-08-20 2003-02-27 Boehringer Ingelheim Pharmaceuticals, Inc. Parenteral formulations of 1-(5-tert-butyl-2-p-tolyl-2h-pryrazol-3-yl)-3-[4-(2-morpholin-4-yl-ethoxy)-naphthalen-1-yl]-urea and a cyclodextrin
US20070111965A1 (en) * 2005-11-15 2007-05-17 Kipp James E Compositions comprising lipoxygenase inhibitors and cyclodextrin
LT2294072T (lt) 2008-05-23 2017-06-12 Wyeth Llc Triazino junginiai, kaip p13 kinazės ir mtor inhibitoriai
US10022381B2 (en) 2008-05-23 2018-07-17 Pfizer Inc. Triazine compounds as PI3 kinase and mTOR inhibitors
WO2010096619A1 (en) 2009-02-23 2010-08-26 Wyeth Llc Process, purification and crystallization of 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea
AR081364A1 (es) * 2010-05-05 2012-08-29 Glaxo Wellcome Mfg Pte Ltd Composiciones farmaceuticas de pazopanib y metodos para su elaboracion
WO2014121235A2 (en) * 2013-02-01 2014-08-07 Zoneone Pharma, Inc. Transformation of drug cyclodextrin complex compositions into compositions of mixtures of lipid vesicle encapsulated drug and cyclodextrin drug complexes
PE20170312A1 (es) * 2014-03-14 2017-03-30 Pfizer Nanoparticulas terapeuticas que comprenden un agente terapeutico, y metodos para su elaboracion y uso
KR101829705B1 (ko) * 2016-09-21 2018-02-19 씨제이헬스케어 주식회사 안정성이 향상된 주사용 조성물
SI3672571T1 (sl) * 2017-08-25 2022-01-31 Pfizer Inc. Farmacevtska vodna raztopina, ki vsebuje 1-(4-((4-(dimetilamino) piperdin-1-il)karbonil)fenil)-3-(4-(4,6-dimorfolin-4-il-1,3, 5-triazin-2-il)fenil)sečnino

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CN112218618A (zh) 2021-01-12
AU2019283550A1 (en) 2020-12-10
WO2019234632A1 (en) 2019-12-12
FI3810089T3 (fi) 2023-09-22
US12109308B2 (en) 2024-10-08
LT3810089T (lt) 2023-11-10
SI3810089T1 (sl) 2023-11-30
US20210212944A1 (en) 2021-07-15
HRP20231337T1 (hr) 2024-02-16
MX2023012527A (es) 2023-10-31
EP3810089A1 (en) 2021-04-28
SI4249069T1 (sl) 2026-01-30
PL3810089T3 (pl) 2024-04-08
JP7423200B2 (ja) 2024-01-29
RS67535B1 (sr) 2026-01-30
CA3102527A1 (en) 2019-12-12
AU2022211854A1 (en) 2022-08-25
EP4249069B1 (en) 2025-11-19
CN112218618B (zh) 2025-04-04
IL279270A (en) 2021-01-31
SMT202300307T1 (it) 2023-11-13
SG11202011256RA (en) 2020-12-30
FI4249069T3 (fi) 2025-12-29
EP4649940A3 (en) 2026-01-21
RS64692B1 (sr) 2023-11-30
AU2022211854B2 (en) 2024-01-04
EP4249069A2 (en) 2023-09-27
PT4249069T (pt) 2025-12-04
MX2020013238A (es) 2021-02-22
KR20210018341A (ko) 2021-02-17
HUE063493T2 (hu) 2024-01-28
JP2019218338A (ja) 2019-12-26
EP4249069A3 (en) 2023-11-29
PL4249069T3 (pl) 2026-02-23
HRP20251602T1 (hr) 2026-01-30
NZ805649A (en) 2024-11-29
NZ770000A (en) 2024-08-30
DK3810089T3 (en) 2023-09-25
KR102583563B1 (ko) 2023-10-05
TW202000234A (zh) 2020-01-01
PT3810089T (pt) 2023-08-23
DK4249069T3 (da) 2025-12-22
CN116270452A (zh) 2023-06-23
TWI696469B (zh) 2020-06-21
EP4649940A2 (en) 2025-11-19
JP7559162B2 (ja) 2024-10-01
KR20230142810A (ko) 2023-10-11
EP3810089B1 (en) 2023-08-02
JP2023138872A (ja) 2023-10-02
LT4249069T (lt) 2026-01-12
BR112020023891A2 (pt) 2021-02-09
US20250064732A1 (en) 2025-02-27
ES3057278T3 (en) 2026-02-27
SMT202500473T1 (it) 2026-01-12
ES2956225T3 (es) 2023-12-15

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