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
Pending legal-status Critical Current

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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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Transplantation (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

ID=52584085

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)

Application Number Title Priority Date Filing Date
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 (https=)
EP (1) EP3043648B1 (https=)
JP (1) JP6571657B2 (https=)
CN (2) CN109953954A (https=)
AU (5) AU2014311570C1 (https=)
CA (1) CA2922099C (https=)
ES (1) ES2957541T3 (https=)
IL (1) IL244133A0 (https=)
MX (2) MX376522B (https=)
WO (1) WO2015031198A2 (https=)
ZA (1) ZA201601645B (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2957541T3 (es) 2013-08-27 2024-01-22 Vasilios Voudouris Composiciones farmacéuticas de bendamustina
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
CA2317106C (en) * 1997-12-31 2004-11-23 Choongwae Pharma Corporation Method and composition of an oral preparation of itraconazole
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
AU2002346472A1 (en) 2001-11-20 2003-06-10 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
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
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
US20090130198A1 (en) 2007-11-21 2009-05-21 Innopharmax Inc. Pharmaceutical composition with enhanced bioavailability
AR072777A1 (es) 2008-03-26 2010-09-22 Cephalon Inc Formas solidas de clorhidrato de bendamustina
EP2326306A1 (en) 2008-09-25 2011-06-01 Cephalon, Inc. Liquid formulations of bendamustine
EP2367542B1 (en) 2008-12-03 2014-01-01 Astellas Deutschland GmbH Oral dosage forms of bendamustine
WO2010097700A1 (en) * 2009-02-25 2010-09-02 Supratek Pharma, Inc. Bendamustine cyclopolysaccharide compositions
US20100273730A1 (en) 2009-04-27 2010-10-28 Innopharmax, Inc. Self-emulsifying pharmaceutical compositions of hydrophilic drugs and preparation thereof
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WO2011103150A2 (en) 2010-02-18 2011-08-25 Cephalon, Inc. Lyophilized preparations of bendamustine
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ES2957541T3 (es) 2013-08-27 2024-01-22 Vasilios Voudouris Composiciones farmacéuticas de bendamustina
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
JP6571657B2 (ja) 2019-09-04
EP3043648B1 (en) 2023-09-20
IL244133A0 (en) 2016-04-21
US20150065549A1 (en) 2015-03-05
EP3043648A4 (en) 2017-11-22
AU2014311570C1 (en) 2018-08-02
MX2020006075A (es) 2020-08-24
CN105491886A (zh) 2016-04-13
CA2922099A1 (en) 2015-03-05
WO2015031198A3 (en) 2015-04-23
EP3043648C0 (en) 2023-09-20
CN105491886B (zh) 2019-01-29
AU2018206777A1 (en) 2018-08-09
EP3043648A2 (en) 2016-07-20
AU2020286183A1 (en) 2021-01-07
AU2022263496A1 (en) 2022-12-08
ZA201601645B (en) 2017-04-26
AU2020286280A1 (en) 2021-01-14
US20220079923A1 (en) 2022-03-17
US10786486B2 (en) 2020-09-29
MX2016002502A (es) 2017-02-28
MX376522B (es) 2025-03-07
US20180071263A1 (en) 2018-03-15
AU2014311570B2 (en) 2018-04-19
US20210008036A1 (en) 2021-01-14
JP2016531138A (ja) 2016-10-06
US11701344B2 (en) 2023-07-18
AU2014311570A1 (en) 2016-03-10
WO2015031198A2 (en) 2015-03-05
US9061011B1 (en) 2015-06-23
ES2957541T3 (es) 2024-01-22
US20240299363A1 (en) 2024-09-12
US20230310381A1 (en) 2023-10-05
CA2922099C (en) 2022-11-29
US9849115B2 (en) 2017-12-26

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RJ01 Rejection of invention patent application after publication

Application publication date: 20190702

RJ01 Rejection of invention patent application after publication