AU2015229214B2 - Pharmaceutical compositions of therapeutically active compounds - Google Patents

Pharmaceutical compositions of therapeutically active compounds Download PDF

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Publication number
AU2015229214B2
AU2015229214B2 AU2015229214A AU2015229214A AU2015229214B2 AU 2015229214 B2 AU2015229214 B2 AU 2015229214B2 AU 2015229214 A AU2015229214 A AU 2015229214A AU 2015229214 A AU2015229214 A AU 2015229214A AU 2015229214 B2 AU2015229214 B2 AU 2015229214B2
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AU
Australia
Prior art keywords
compound
solid dispersion
pharmaceutical composition
pharmaceutically acceptable
acceptable salt
Prior art date
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AU2015229214A
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English (en)
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AU2015229214A1 (en
Inventor
Chong-Hui Gu
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Laboratoires Servier SAS
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Laboratoires Servier SAS
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Application filed by Laboratoires Servier SAS filed Critical Laboratoires Servier SAS
Publication of AU2015229214A1 publication Critical patent/AU2015229214A1/en
Application granted granted Critical
Publication of AU2015229214B2 publication Critical patent/AU2015229214B2/en
Priority to AU2019246824A priority Critical patent/AU2019246824B2/en
Assigned to LES LABORATOIRES SERVIER SAS reassignment LES LABORATOIRES SERVIER SAS Request for Assignment Assignors: AGIOS PHARMACEUTICALS, INC.
Assigned to LES LABORATOIRES SERVIER reassignment LES LABORATOIRES SERVIER Request to Amend Deed and Register Assignors: LES LABORATOIRES SERVIER SAS
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Anticipated expiration legal-status Critical

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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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/146Intimate 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D251/00Heterocyclic compounds containing 1,3,5-triazine rings
    • C07D251/02Heterocyclic compounds containing 1,3,5-triazine rings not condensed with other rings
    • C07D251/12Heterocyclic compounds containing 1,3,5-triazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members
    • C07D251/14Heterocyclic compounds containing 1,3,5-triazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members with hydrogen or carbon atoms directly attached to at least one ring carbon atom
    • C07D251/16Heterocyclic compounds containing 1,3,5-triazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members with hydrogen or carbon atoms directly attached to at least one ring carbon atom to only one ring carbon atom
    • C07D251/18Heterocyclic compounds containing 1,3,5-triazine rings not condensed with other rings having three double bonds between ring members or between ring members and non-ring members with hydrogen or carbon atoms directly attached to at least one ring carbon atom to only one ring carbon atom with nitrogen atoms directly attached to the two other ring carbon atoms, e.g. guanamines
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/14Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Pyridine Compounds (AREA)
AU2015229214A 2014-03-14 2015-03-13 Pharmaceutical compositions of therapeutically active compounds Active AU2015229214B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2019246824A AU2019246824B2 (en) 2014-03-14 2019-10-10 Pharmaceutical compositions of therapeutically active compounds and their methods of use

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461953487P 2014-03-14 2014-03-14
US61/953,487 2014-03-14
US201462081542P 2014-11-18 2014-11-18
US62/081,542 2014-11-18
PCT/US2015/020349 WO2015138839A1 (en) 2014-03-14 2015-03-13 Pharmaceutical compositions of therapeutically active compounds

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2019246824A Division AU2019246824B2 (en) 2014-03-14 2019-10-10 Pharmaceutical compositions of therapeutically active compounds and their methods of use

Publications (2)

Publication Number Publication Date
AU2015229214A1 AU2015229214A1 (en) 2016-09-22
AU2015229214B2 true AU2015229214B2 (en) 2019-07-11

Family

ID=54072441

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2015229214A Active AU2015229214B2 (en) 2014-03-14 2015-03-13 Pharmaceutical compositions of therapeutically active compounds
AU2019246824A Active 2038-04-05 AU2019246824B2 (en) 2014-03-14 2019-10-10 Pharmaceutical compositions of therapeutically active compounds and their methods of use

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2019246824A Active 2038-04-05 AU2019246824B2 (en) 2014-03-14 2019-10-10 Pharmaceutical compositions of therapeutically active compounds and their methods of use

Country Status (16)

Country Link
US (4) US9968595B2 (enExample)
EP (1) EP3116492A4 (enExample)
JP (4) JP6564796B2 (enExample)
KR (4) KR20220070066A (enExample)
CN (2) CN106255498B (enExample)
AU (2) AU2015229214B2 (enExample)
CA (1) CA2942072C (enExample)
EA (1) EA036325B1 (enExample)
IL (2) IL247722B (enExample)
MA (1) MA39726A (enExample)
MX (2) MX376329B (enExample)
NZ (1) NZ723859A (enExample)
PH (2) PH12021551647A1 (enExample)
UA (1) UA121211C2 (enExample)
WO (1) WO2015138839A1 (enExample)
ZA (2) ZA202308495B (enExample)

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US20150031627A1 (en) 2013-07-25 2015-01-29 Agios Pharmaceuticals, Inc Therapeutically active compounds and their methods of use
EA036325B1 (ru) 2014-03-14 2020-10-27 Аджиос Фармасьютикалз, Инк. Фармацевтическая композиция на основе твердой дисперсии ингибитора idh1
UA123401C2 (uk) 2015-10-15 2021-03-31 Аджиос Фармасьютікалз, Інк. Комбінована терапія для лікування злоякісних пухлин
US9890163B2 (en) 2015-10-15 2018-02-13 Princeton Drug Discovery Inc Inhibitors of protein kinases
ES2897959T3 (es) * 2015-10-15 2022-03-03 Servier Lab Terapia de combinación para tratar neoplasias malignas
IL299563A (en) * 2015-12-04 2023-02-01 Agios Pharmaceuticals Inc Methods of treatment of acute myeloid leukemia characterized by the presence of a mutant allele of idh2 and the absence of a mutant allele of nras
CA3015753A1 (en) * 2016-02-26 2017-08-31 Celgene Corporation Idh2 inhibitors for the treatment of haematological maligancies and solid tumours
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WO2019104318A1 (en) 2017-11-27 2019-05-31 Teva Pharmaceuticals Usa, Inc. Solid state forms of ivosidenib
CN108226323A (zh) * 2017-12-13 2018-06-29 重庆华邦胜凯制药有限公司 一种测定异烟肼起始原料4-氰基吡啶及其杂质含量的方法
US10980788B2 (en) 2018-06-08 2021-04-20 Agios Pharmaceuticals, Inc. Therapy for treating malignancies
US12264148B2 (en) * 2018-07-06 2025-04-01 Servier Pharmaceuticals Llc Ivosidenib forms and pharmaceutical compositions
KR20210102211A (ko) 2018-10-24 2021-08-19 이펙터 테라퓨틱스, 인크. Mnk 억제제의 결정질 형태
CN116473973A (zh) * 2018-12-24 2023-07-25 正大天晴药业集团股份有限公司 吡咯并嘧啶化合物的治疗用途及其固体药物组合物
CN114555584B (zh) 2019-08-08 2024-07-05 法国施维雅药厂 艾伏尼布(ivosidenib)及其中间体之制备方法
GB201912411D0 (en) * 2019-08-29 2019-10-16 Johnson Matthey Plc Crystalline forms of ivosidenib
WO2021071678A1 (en) 2019-10-07 2021-04-15 University Hospitals Cleveland Medical Center Methods for treating wild type isocitrate dehydrogenase 1 cancers
WO2021079380A1 (en) * 2019-10-23 2021-04-29 Msn Laboratories Private Limited, R&D Center Improved process for the preparation of (2s)-n-{(1s)-1-(2-chlorophenyl)-2-[(3,3-difluorocyclobutyl)-amino]-2-oxoethyl}-1-(4-cyanopyridin-2-yl)-n-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide
JP2024516817A (ja) * 2021-01-27 2024-04-17 ウェルスタット セラピューティクス コーポレイション ウリジントリアセテート非晶質製剤
WO2022243886A1 (en) * 2021-05-21 2022-11-24 Alembic Pharmaceuticals Limited Pharmaceutical composition of ivosidenib
AU2023312625A1 (en) * 2022-07-26 2025-03-13 Pharma Cinq, Llc Uridine triacetate amorphous formulation and uses thereof
AR133410A1 (es) 2023-08-01 2025-09-24 Servier Lab Cocristal de un inhibidor de idh1, proceso de preparación del mismo, composiciones farmacéuticas del mismo, y métodos de tratamiento que implican el mismo

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