CN109953954A - 苯达莫司汀医药组合物 - Google Patents

苯达莫司汀医药组合物 Download PDF

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Publication number
CN109953954A
CN109953954A CN201910051265.7A CN201910051265A CN109953954A CN 109953954 A CN109953954 A CN 109953954A CN 201910051265 A CN201910051265 A CN 201910051265A CN 109953954 A CN109953954 A CN 109953954A
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CN
China
Prior art keywords
bendamustine
certain embodiments
spray
solid dispersion
dried
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.)
Pending
Application number
CN201910051265.7A
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English (en)
Chinese (zh)
Inventor
V·沃道里斯
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Individual
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Individual
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Filing date
Publication date
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Publication of CN109953954A publication Critical patent/CN109953954A/zh
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Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Transplantation (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Inorganic Chemistry (AREA)
CN201910051265.7A 2013-08-27 2014-08-22 苯达莫司汀医药组合物 Pending CN109953954A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361870609P 2013-08-27 2013-08-27
US61/870,609 2013-08-27
CN201480045199.8A CN105491886B (zh) 2013-08-27 2014-08-22 苯达莫司汀医药组合物

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201480045199.8A Division CN105491886B (zh) 2013-08-27 2014-08-22 苯达莫司汀医药组合物

Publications (1)

Publication Number Publication Date
CN109953954A true CN109953954A (zh) 2019-07-02

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
CN201910051265.7A Pending CN109953954A (zh) 2013-08-27 2014-08-22 苯达莫司汀医药组合物
CN201480045199.8A Active CN105491886B (zh) 2013-08-27 2014-08-22 苯达莫司汀医药组合物

Family Applications After (1)

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CN201480045199.8A Active CN105491886B (zh) 2013-08-27 2014-08-22 苯达莫司汀医药组合物

Country Status (11)

Country Link
US (7) US9849115B2 (enExample)
EP (1) EP3043648B1 (enExample)
JP (1) JP6571657B2 (enExample)
CN (2) CN109953954A (enExample)
AU (5) AU2014311570C1 (enExample)
CA (1) CA2922099C (enExample)
ES (1) ES2957541T3 (enExample)
IL (1) IL244133A0 (enExample)
MX (2) MX376522B (enExample)
WO (1) WO2015031198A2 (enExample)
ZA (1) ZA201601645B (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109953954A (zh) 2013-08-27 2019-07-02 V·沃道里斯 苯达莫司汀医药组合物
CA2941632C (en) * 2014-03-13 2023-10-24 Vasilios VOUDOURIS Bendamustine solid dispersions and continuous infusion
JP6937016B2 (ja) * 2017-09-06 2021-09-22 東京理化器械株式会社 噴霧乾燥装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080206350A1 (en) * 2007-02-22 2008-08-28 Evonik Roehm Gmbh Pellets having a gastric juice-resistant active compound matrix
CN102292073A (zh) * 2008-12-03 2011-12-21 安斯泰来德国有限公司 苯达莫司汀的固体剂型
CN102413816A (zh) * 2009-04-28 2012-04-11 赛福伦公司 苯达莫司汀的口服制剂
CN103037852A (zh) * 2010-06-02 2013-04-10 安斯泰来德国有限公司 苯达莫司汀的口服剂型及其治疗用途

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US20030203036A1 (en) * 2000-03-17 2003-10-30 Gordon Marc S. Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients
PL191181B1 (pl) * 1997-12-31 2006-03-31 Choongwae Pharma Corp Sposób wytwarzania doustnego preparatu itrakonazolu i doustny preparat itrakonazolu
SE0000773D0 (sv) 2000-03-08 2000-03-08 Astrazeneca Ab New formulation
US20030105141A1 (en) 2001-04-17 2003-06-05 Ping Gao Finely self-emulsifiable pharmaceutical composition
JP4644397B2 (ja) * 2001-09-05 2011-03-02 信越化学工業株式会社 難溶性薬物を含む医薬用固形製剤の製造方法
US20030129250A1 (en) 2001-11-20 2003-07-10 Advanced Inhalation Research Inc. Particulate compositions for improving solubility of poorly soluble agents
US8436190B2 (en) * 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
CN1887261A (zh) * 2006-07-25 2007-01-03 济南帅华医药科技有限公司 含苯达莫司汀的复方抗癌缓释注射剂
CN1887269A (zh) * 2006-07-25 2007-01-03 济南帅华医药科技有限公司 一种含苯达莫司汀及其增效剂的抗癌缓释注射剂
US20090130198A1 (en) 2007-11-21 2009-05-21 Innopharmax Inc. Pharmaceutical composition with enhanced bioavailability
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CN104224703A (zh) * 2008-09-25 2014-12-24 赛福伦公司 苯达莫司汀的液体配制品
NZ592970A (en) 2008-12-03 2013-05-31 Astellas Deutschland Gmbh Oral dosage forms of bendamustine
AU2010217297A1 (en) * 2009-02-25 2011-10-20 Supratek Pharma, Inc. Bendamustine cyclopolysaccharide compositions
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WO2014004707A1 (en) 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
CN109953954A (zh) 2013-08-27 2019-07-02 V·沃道里斯 苯达莫司汀医药组合物
CA2941632C (en) 2014-03-13 2023-10-24 Vasilios VOUDOURIS Bendamustine solid dispersions and continuous infusion

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080206350A1 (en) * 2007-02-22 2008-08-28 Evonik Roehm Gmbh Pellets having a gastric juice-resistant active compound matrix
CN102292073A (zh) * 2008-12-03 2011-12-21 安斯泰来德国有限公司 苯达莫司汀的固体剂型
CN102413816A (zh) * 2009-04-28 2012-04-11 赛福伦公司 苯达莫司汀的口服制剂
CN103037852A (zh) * 2010-06-02 2013-04-10 安斯泰来德国有限公司 苯达莫司汀的口服剂型及其治疗用途

Also Published As

Publication number Publication date
MX2016002502A (es) 2017-02-28
AU2014311570A1 (en) 2016-03-10
ES2957541T3 (es) 2024-01-22
EP3043648A4 (en) 2017-11-22
AU2014311570B2 (en) 2018-04-19
EP3043648B1 (en) 2023-09-20
US10786486B2 (en) 2020-09-29
US9849115B2 (en) 2017-12-26
AU2018206777A1 (en) 2018-08-09
WO2015031198A3 (en) 2015-04-23
US20210008036A1 (en) 2021-01-14
AU2020286183A1 (en) 2021-01-07
MX376522B (es) 2025-03-07
US20180071263A1 (en) 2018-03-15
EP3043648A2 (en) 2016-07-20
AU2014311570C1 (en) 2018-08-02
US20240299363A1 (en) 2024-09-12
US20230310381A1 (en) 2023-10-05
MX2020006075A (es) 2020-08-24
US11701344B2 (en) 2023-07-18
US20220079923A1 (en) 2022-03-17
US9061011B1 (en) 2015-06-23
AU2022263496A1 (en) 2022-12-08
EP3043648C0 (en) 2023-09-20
JP6571657B2 (ja) 2019-09-04
CN105491886B (zh) 2019-01-29
US12661337B2 (en) 2026-06-23
US20150065549A1 (en) 2015-03-05
CN105491886A (zh) 2016-04-13
AU2020286280A1 (en) 2021-01-14
CA2922099A1 (en) 2015-03-05
IL244133A0 (en) 2016-04-21
WO2015031198A2 (en) 2015-03-05
JP2016531138A (ja) 2016-10-06
ZA201601645B (en) 2017-04-26
CA2922099C (en) 2022-11-29

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Application publication date: 20190702

RJ01 Rejection of invention patent application after publication