WO2010039798A3 - Compositions amorphes d’une base de sunitinib et d’acide l-malique - Google Patents

Compositions amorphes d’une base de sunitinib et d’acide l-malique Download PDF

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Publication number
WO2010039798A3
WO2010039798A3 PCT/US2009/058975 US2009058975W WO2010039798A3 WO 2010039798 A3 WO2010039798 A3 WO 2010039798A3 US 2009058975 W US2009058975 W US 2009058975W WO 2010039798 A3 WO2010039798 A3 WO 2010039798A3
Authority
WO
WIPO (PCT)
Prior art keywords
malic acid
sunitinib base
amorphous compositions
sunitinib
amorphous
Prior art date
Application number
PCT/US2009/058975
Other languages
English (en)
Other versions
WO2010039798A2 (fr
Inventor
Alexandr Jegorov
Ales Gavenda
Pavel Vraspir
Judith Aronhime
Original Assignee
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceuticals Usa, Inc.
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 Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals Usa, Inc. filed Critical Teva Pharmaceutical Industries Ltd.
Priority to CA2704448A priority Critical patent/CA2704448A1/fr
Publication of WO2010039798A2 publication Critical patent/WO2010039798A2/fr
Publication of WO2010039798A3 publication Critical patent/WO2010039798A3/fr

Links

Classifications

    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • 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
    • A61K47/38—Cellulose; Derivatives 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
    • A61K47/30—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
    • C07D209/30—Indoles; Hydrogenated indoles with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, directly attached to carbon atoms of the hetero ring
    • C07D209/32—Oxygen atoms
    • C07D209/34—Oxygen atoms in position 2

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L’invention concerne la préparation de combinaisons d’un excipient pharmaceutiquement acceptable choisi parmi le groupe constitué de la cellulose microcristalline, de la polyvinylpyrrolidone, de la cyclodextrine et d’un disaccharide ou de dérivés de ceux-ci, et d’une composition d’une base de sunitinib et d’acide L-malique.
PCT/US2009/058975 2008-09-30 2009-09-30 Compositions amorphes d’une base de sunitinib et d’acide l-malique WO2010039798A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2704448A CA2704448A1 (fr) 2008-09-30 2009-09-30 Compositions amorphes d'une base de sunitinib et d'acide l-malique

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US10152708P 2008-09-30 2008-09-30
US61/101,527 2008-09-30
US11741308P 2008-11-24 2008-11-24
US61/117,413 2008-11-24
US14347709P 2009-01-09 2009-01-09
US61/143,477 2009-01-09
US15964409P 2009-03-12 2009-03-12
US61/159,644 2009-03-12

Publications (2)

Publication Number Publication Date
WO2010039798A2 WO2010039798A2 (fr) 2010-04-08
WO2010039798A3 true WO2010039798A3 (fr) 2010-08-19

Family

ID=41815067

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/058975 WO2010039798A2 (fr) 2008-09-30 2009-09-30 Compositions amorphes d’une base de sunitinib et d’acide l-malique

Country Status (3)

Country Link
KR (1) KR20100051769A (fr)
CA (1) CA2704448A1 (fr)
WO (1) WO2010039798A2 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104069076A (zh) * 2013-03-29 2014-10-01 浙江九洲药业股份有限公司 一种无定型的舒尼替尼与pvp的组合物
WO2015031604A1 (fr) 2013-08-28 2015-03-05 Crown Bioscience, Inc. Signatures d'expression génique permettant de prédire la réponse d'un sujet à un inhibiteur multikinase et leurs procédés d'utilisation
WO2020091439A1 (fr) * 2018-10-31 2020-05-07 주식회사 삼양바이오팜 Formulation orale comprenant du sunitinib et procédé de préparation de celle-ci
KR102308227B1 (ko) * 2018-10-31 2021-10-05 주식회사 삼양홀딩스 수니티닙을 함유하는 경구용 정제 조성물
EP3958845A1 (fr) 2019-04-25 2022-03-02 Synthon B.V. Composition pharmaceutique comprenant du sunitinib amorphe
JPWO2020261619A1 (fr) * 2019-06-26 2020-12-30
KR20240025990A (ko) * 2022-08-19 2024-02-27 주식회사 스카이테라퓨틱스 무정형 수니티닙, 그 제조방법 및 이를 포함한 의약 조성물

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004024127A2 (fr) * 2002-09-10 2004-03-25 Pharmacia Italia S.P.A. Formulations contenant un compose indolinone
EP2090306A1 (fr) * 2008-02-13 2009-08-19 Ratiopharm GmbH Compositions pharmaceutiques comportant du N-[2-(diethylamino)ethyl]-5-[5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004024127A2 (fr) * 2002-09-10 2004-03-25 Pharmacia Italia S.P.A. Formulations contenant un compose indolinone
EP2090306A1 (fr) * 2008-02-13 2009-08-19 Ratiopharm GmbH Compositions pharmaceutiques comportant du N-[2-(diethylamino)ethyl]-5-[5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PETIT S ET AL: "The Amorphous State", 1 January 2006, 20060101, PAGE(S) 259 - 285, ISBN: 9783527311460, XP002481458 *

Also Published As

Publication number Publication date
CA2704448A1 (fr) 2010-04-08
WO2010039798A2 (fr) 2010-04-08
KR20100051769A (ko) 2010-05-18

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