CN101516339B - 制备高度结晶的治疗化合物的固体分散体的方法 - Google Patents

制备高度结晶的治疗化合物的固体分散体的方法 Download PDF

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Publication number
CN101516339B
CN101516339B CN2007800302086A CN200780030208A CN101516339B CN 101516339 B CN101516339 B CN 101516339B CN 2007800302086 A CN2007800302086 A CN 2007800302086A CN 200780030208 A CN200780030208 A CN 200780030208A CN 101516339 B CN101516339 B CN 101516339B
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China
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poloxamer
therapeutic compound
therapeutic compounds
highly crystalline
therapeutic
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Expired - Fee Related
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CN2007800302086A
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English (en)
Chinese (zh)
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CN101516339A (zh
Inventor
I·高希
J·斯奈德
W-Q·童
S·维帕贡塔
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Novartis AG
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Novartis AG
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or 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
    • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Colloid Chemistry (AREA)
  • Glass Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Peptides Or Proteins (AREA)
CN2007800302086A 2006-08-16 2007-08-14 制备高度结晶的治疗化合物的固体分散体的方法 Expired - Fee Related CN101516339B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US82255606P 2006-08-16 2006-08-16
US60/822,556 2006-08-16
PCT/US2007/017960 WO2008021347A2 (en) 2006-08-16 2007-08-14 Method for making solid dispersions of highly crystalline therapeutic compounds

Publications (2)

Publication Number Publication Date
CN101516339A CN101516339A (zh) 2009-08-26
CN101516339B true CN101516339B (zh) 2012-06-13

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US (2) US20100038816A1 (enExample)
EP (1) EP2054040B1 (enExample)
JP (1) JP5546860B2 (enExample)
KR (1) KR101462693B1 (enExample)
CN (1) CN101516339B (enExample)
AT (1) ATE503484T1 (enExample)
AU (1) AU2007284615B2 (enExample)
BR (1) BRPI0714963A2 (enExample)
CA (1) CA2660086C (enExample)
DE (1) DE602007013567D1 (enExample)
ES (1) ES2363725T3 (enExample)
MX (1) MX2009001636A (enExample)
PL (1) PL2054040T3 (enExample)
PT (1) PT2054040E (enExample)
RU (1) RU2454220C2 (enExample)
WO (1) WO2008021347A2 (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1923053A1 (en) 2006-09-27 2008-05-21 Novartis AG Pharmaceutical compositions comprising nilotinib or its salt
WO2009100176A2 (en) * 2008-02-07 2009-08-13 Abbott Laboratories Pharmaceutical dosage form for oral administration of tyrosine kinase inhibitor
MX2010011962A (es) * 2008-04-30 2010-11-30 Novartis Ag Proceso continuo para hacer composiciones farmaceuticas.
EP2327706A1 (en) 2009-11-30 2011-06-01 Novartis AG Polymorphous forms III and IV of N-benzoyl-staurosporine
UA113500C2 (xx) 2010-10-29 2017-02-10 Одержані екструзією розплаву тверді дисперсії, що містять індукуючий апоптоз засіб
CN102525879B (zh) * 2010-12-31 2015-01-21 正大天晴药业集团股份有限公司 制备阿瑞匹坦固体分散组合物的方法
HRP20200372T1 (hr) * 2014-03-25 2020-06-12 F. Hoffmann - La Roche Ag Postupci proizvodnje poloksamera za upotrebu u mediju za staničnu kulturu
CA2970717A1 (en) 2014-12-18 2016-06-23 Merck Sharp & Dohme Corp. (s)-n-(3-(6-isopropoxypyridin-3-yl)-1h-indazol-5-yl)-1-(2-(4-(4-(1-methyl-1h-1,2,4-triazol-3-yl)phenyl)-3,6-dihydropyridin-1(2h)-yl)-2-oxoethyl)-3- (methylthio)pyrrolidine-3-carboxamide compositions for pharmaceutical preparations
GB201502073D0 (en) * 2015-02-09 2015-03-25 Cubic Pharmaceuticals Ltd And Delta Pharmaceuticals Ltd HDEG technology
EP3337454B1 (en) 2015-08-20 2018-12-26 Unilever Plc. Improved lactam solubility
EP3337448A1 (en) * 2015-08-20 2018-06-27 Unilever PLC, a company registered in England and Wales under company no. 41424 of Dispersed lactams
WO2017029104A1 (en) 2015-08-20 2017-02-23 Unilever Plc Process for the preparation of lactams from glyoxylic acid
WO2017029092A1 (en) 2015-08-20 2017-02-23 Unilever Plc Improved lactam solubility
TR201901410T4 (tr) 2015-08-20 2019-02-21 Unilever Nv Geliştirilmiş Laktam Çözünürlüğü
CN107920979A (zh) 2015-08-20 2018-04-17 荷兰联合利华有限公司 改善的内酰胺溶解度
CN108024939B (zh) 2015-08-20 2024-06-07 联合利华知识产权控股有限公司 包封的内酰胺
CA3018629A1 (en) * 2016-03-24 2017-09-28 Locate Therapeutics Limited Scaffolding material, methods and uses
US11510986B2 (en) * 2016-05-13 2022-11-29 Merck Patent Gmbh Hot melt extrusion composition using direct compressible excipient as plasticizer
WO2019152798A1 (en) 2018-02-01 2019-08-08 Corvus Pharmaceuticals, Inc. Pharmaceutical formulations
EP3520782A3 (en) * 2018-02-01 2019-11-13 Corvus Pharmaceuticals, Inc. Pharmaceutical formulations containing adenosine a2a receptor antagonists
CN113573712A (zh) 2019-02-18 2021-10-29 斯莱班克制药有限责任公司 尼洛替尼的药物组合物
CA3203975A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
CA3216359A1 (en) 2021-04-07 2022-10-13 Battelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
CN114796149A (zh) * 2022-04-27 2022-07-29 苏州中化药品工业有限公司 一种高生物利用度的双醋瑞因胶囊剂及其制备方法
AU2024353375A1 (en) 2023-09-29 2026-04-09 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025122954A1 (en) 2023-12-08 2025-06-12 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006024494A1 (en) * 2004-08-31 2006-03-09 Novartis Ag Use of midostaurin for treating gastrointestinal stromal tumors

Family Cites Families (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3346123A1 (de) 1983-12-21 1985-06-27 Janssen Pharmaceutica, N.V., Beerse Pharmazeutische praeparate von in wasser schwerloeslichen oder instabilen arzneistoffen und verfahren zu ihrer herstellung
IE80467B1 (en) 1995-07-03 1998-07-29 Elan Corp Plc Controlled release formulations for poorly soluble drugs
US5837714A (en) * 1997-03-03 1998-11-17 Sanofi Solid pharmaceutical dispersions
DE69811233T2 (de) 1997-10-27 2003-11-20 Merck Patent Gmbh Feste lösungen und dispersionen von eines schlecht wasserlöslichen wirkstoffes
US6706283B1 (en) * 1999-02-10 2004-03-16 Pfizer Inc Controlled release by extrusion of solid amorphous dispersions of drugs
GB9903547D0 (en) * 1999-02-16 1999-04-07 Novartis Ag Organic compounds
US20060034937A1 (en) * 1999-11-23 2006-02-16 Mahesh Patel Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US6593308B2 (en) * 1999-12-03 2003-07-15 The Regents Of The University Of California Targeted drug delivery with a hyaluronan ligand
US20020015730A1 (en) * 2000-03-09 2002-02-07 Torsten Hoffmann Pharmaceutical formulations and method for making
DE10013289A1 (de) * 2000-03-17 2001-09-20 Knoll Ag Torasemid enthaltende pharmazeutische Zubereitungen
PT1372611E (pt) * 2001-03-26 2006-08-31 Novartis Ag Composicao farmaceutica compreendendo uma estaurosporina francamente soluvel em agua, um tensioactivo et um polimero soluvel em agua
CN1255185C (zh) * 2001-05-03 2006-05-10 弗·哈夫曼-拉罗切有限公司 无定形甲磺酸奈非那韦的药物剂型
US20030212102A1 (en) * 2001-06-12 2003-11-13 Koretke Todd W Novel solid dispersion compositions
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
US6756381B2 (en) * 2002-02-21 2004-06-29 Supergen, Inc. Compositions and formulations of 9-nitrocamptothecin polymorphs and methods of use thereof
GB0205253D0 (en) * 2002-03-06 2002-04-17 Univ Gent Immediate release pharmaceutical granule compositions and a continuous process for making them
US8268352B2 (en) * 2002-08-05 2012-09-18 Torrent Pharmaceuticals Limited Modified release composition for highly soluble drugs
US7230012B2 (en) * 2002-11-14 2007-06-12 Celgene Corporation Pharmaceutical compositions and dosage forms of thalidomide
GB0315012D0 (en) * 2003-06-27 2003-07-30 Leuven K U Res & Dev Zeotiles
AR047938A1 (es) * 2003-08-25 2006-03-15 Combinatorx Inc Formulaciones, conjugados y combinaciones de farmacos para el tratamiento de neoplasmas
US20050208095A1 (en) * 2003-11-20 2005-09-22 Angiotech International Ag Polymer compositions and methods for their use
KR20060101762A (ko) * 2003-11-21 2006-09-26 쉐링 코포레이션 포스포디에스테라제 ｖ 억제제 제형
WO2005053727A2 (en) * 2003-11-29 2005-06-16 Sangstat Medical Corporation Pharmaceutical compositions for bioactive peptide agents
UA85871C2 (uk) * 2004-03-15 2009-03-10 Такеда Фармасьютікал Компані Лімітед Інгібітори дипептидилпептидази
US20060246109A1 (en) * 2005-04-29 2006-11-02 Hossainy Syed F Concentration gradient profiles for control of agent release rates from polymer matrices
US20050288481A1 (en) * 2004-04-30 2005-12-29 Desnoyer Jessica R Design of poly(ester amides) for the control of agent-release from polymeric compositions
US20080038316A1 (en) * 2004-10-01 2008-02-14 Wong Vernon G Conveniently implantable sustained release drug compositions
JO2897B1 (en) * 2004-11-05 2015-09-15 نوفارتيس ايه جي Organic compounds
JP2008521878A (ja) * 2004-12-02 2008-06-26 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー 非晶質アトルバスタチンの医薬組成物及びその製造のための方法
PT1962808E (pt) * 2005-12-14 2010-10-29 Hoffmann La Roche Formulação de precursor de fármaco para o hcv
DK2526933T3 (en) * 2006-09-22 2015-05-18 Pharmacyclics Inc Inhibitors of Bruton's tyrosine kinase
US8258137B2 (en) * 2008-01-29 2012-09-04 Katholieke Universiteit Leuven Process for release of biologically active species from mesoporous oxide systems
CN102413839A (zh) * 2009-03-06 2012-04-11 医学免疫有限责任公司 人源化抗cd19抗体制剂
TW201120037A (en) * 2009-10-26 2011-06-16 Sunesis Pharmaceuticals Inc Compounds and methods for treatment of cancer
EP2327706A1 (en) * 2009-11-30 2011-06-01 Novartis AG Polymorphous forms III and IV of N-benzoyl-staurosporine
CA3007787C (en) * 2010-06-03 2020-03-10 Pharmacyclics Llc The use of inhibitors of bruton's tyrosine kinase (btk)
EP2618846A1 (en) * 2010-09-24 2013-07-31 Mallinckrodt LLC Aptamer conjugates for targeting of therapeutic and/or diagnostic nanocarriers
US9295673B2 (en) * 2011-02-23 2016-03-29 Intellikine Llc Combination of mTOR inhibitors and P13-kinase inhibitors, and uses thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006024494A1 (en) * 2004-08-31 2006-03-09 Novartis Ag Use of midostaurin for treating gastrointestinal stromal tumors

Also Published As

Publication number Publication date
MX2009001636A (es) 2009-02-23
PL2054040T3 (pl) 2011-09-30
JP2010500411A (ja) 2010-01-07
PT2054040E (pt) 2011-06-30
US20100038816A1 (en) 2010-02-18
KR101462693B1 (ko) 2014-11-17
JP5546860B2 (ja) 2014-07-09
ES2363725T3 (es) 2011-08-12
AU2007284615B2 (en) 2011-10-27
CA2660086A1 (en) 2008-02-21
US20120190667A1 (en) 2012-07-26
RU2009109357A (ru) 2010-09-27
ATE503484T1 (de) 2011-04-15
RU2454220C2 (ru) 2012-06-27
AU2007284615A1 (en) 2008-02-21
EP2054040B1 (en) 2011-03-30
WO2008021347A2 (en) 2008-02-21
EP2054040A2 (en) 2009-05-06
DE602007013567D1 (de) 2011-05-12
BRPI0714963A2 (pt) 2013-07-30
CN101516339A (zh) 2009-08-26
WO2008021347A3 (en) 2008-08-07
KR20090042961A (ko) 2009-05-04
CA2660086C (en) 2014-09-16
US8641948B2 (en) 2014-02-04

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