JP2008501802A - 医薬組成物 - Google Patents

医薬組成物 Download PDF

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Publication number
JP2008501802A
JP2008501802A JP2007527639A JP2007527639A JP2008501802A JP 2008501802 A JP2008501802 A JP 2008501802A JP 2007527639 A JP2007527639 A JP 2007527639A JP 2007527639 A JP2007527639 A JP 2007527639A JP 2008501802 A JP2008501802 A JP 2008501802A
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JP
Japan
Prior art keywords
solid dispersion
polymer
pharmaceutical composition
amorphous
surfactant
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
JP2007527639A
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English (en)
Japanese (ja)
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JP2008501802A5 (enExample
Inventor
マウラ・マーフィー
カーク・ダインハート
パトリシア・ハーター
パトリック・コネリー
クイ・ヨン
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Vertex Pharmaceuticals Inc
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Vertex Pharmaceuticals Inc
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Publication date
Application filed by Vertex Pharmaceuticals Inc filed Critical Vertex Pharmaceuticals Inc
Publication of JP2008501802A publication Critical patent/JP2008501802A/ja
Publication of JP2008501802A5 publication Critical patent/JP2008501802A5/ja
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/07—Tetrapeptides
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965—Non-condensed pyrazines
    • A61K31/497—Non-condensed pyrazines containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/141—Intimate 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
    • A61K9/145—Intimate 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 compounds
    • 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
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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
    • 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
    • A61K9/1652—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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Mechanical Treatment Of Semiconductor (AREA)
JP2007527639A 2004-06-08 2005-06-08 医薬組成物 Pending JP2008501802A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US57804304P 2004-06-08 2004-06-08
PCT/US2005/019929 WO2005123076A2 (en) 2004-06-08 2005-06-08 Pharmaceutical compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2012000814A Division JP5337262B2 (ja) 2004-06-08 2012-01-05 医薬組成物

Publications (2)

Publication Number Publication Date
JP2008501802A true JP2008501802A (ja) 2008-01-24
JP2008501802A5 JP2008501802A5 (enExample) 2008-07-24

Family

ID=35510250

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2007527639A Pending JP2008501802A (ja) 2004-06-08 2005-06-08 医薬組成物
JP2012000814A Expired - Fee Related JP5337262B2 (ja) 2004-06-08 2012-01-05 医薬組成物

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2012000814A Expired - Fee Related JP5337262B2 (ja) 2004-06-08 2012-01-05 医薬組成物

Country Status (18)

Country Link
US (2) US20060089385A1 (enExample)
EP (1) EP1765283A4 (enExample)
JP (2) JP2008501802A (enExample)
KR (2) KR101370580B1 (enExample)
CN (2) CN1988885A (enExample)
AR (1) AR049297A1 (enExample)
AU (1) AU2005253957B2 (enExample)
BR (1) BRPI0511900A (enExample)
CA (1) CA2569310A1 (enExample)
IL (2) IL179809A (enExample)
MX (1) MXPA06014253A (enExample)
NO (1) NO20070130L (enExample)
NZ (1) NZ588471A (enExample)
RU (1) RU2373923C2 (enExample)
SG (1) SG153800A1 (enExample)
TW (1) TWI389688B (enExample)
WO (1) WO2005123076A2 (enExample)
ZA (2) ZA200700030B (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012503669A (ja) * 2008-09-24 2012-02-09 バーテックス ファーマシューティカルズ インコーポレイテッド 肝炎を治療するためのｐｅｇ−インターフェロン、リバビリンおよびｖｘ−９５０を含む治療レジメ
JP2014507424A (ja) * 2011-03-08 2014-03-27 ザリカス ファーマスーティカルズ リミテッド 固体分散物製剤およびその使用方法
JP2015503560A (ja) * 2011-12-29 2015-02-02 アッヴィ・インコーポレイテッド Ｈｃｖ阻害剤を含む固体組成物

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DK0932617T3 (da) * 1996-10-18 2002-04-22 Vertex Pharma Inhibitorer af serinproteaser, især af hepatitis C-virus-NS3-protease
SV2003000617A (es) 2000-08-31 2003-01-13 Lilly Co Eli Inhibidores de la proteasa peptidomimetica ref. x-14912m
MY169670A (en) 2003-09-03 2019-05-08 Tibotec Pharm Ltd Combinations of a pyrimidine containing nnrti with rt inhibitors
PE20050374A1 (es) * 2003-09-05 2005-05-30 Vertex Pharma Inhibidores de proteasas de serina, en particular proteasa ns3-ns4a del vhc
TW201424733A (zh) * 2004-10-29 2014-07-01 Vertex Pharma 劑量型式
CA2610167A1 (en) 2005-06-02 2006-12-07 Schering Corporation Administration of hcv protease inhibitors in combination with food to improve bioavailability
BRPI0610737A2 (pt) 2005-06-02 2010-07-20 Schering Corp formulações farmacêuticas e métodos de tratamento usando as mesmas
KR20080033481A (ko) * 2005-08-02 2008-04-16 버텍스 파마슈티칼스 인코포레이티드 세린 프로테아제의 억제제
US8399615B2 (en) 2005-08-19 2013-03-19 Vertex Pharmaceuticals Incorporated Processes and intermediates
US7964624B1 (en) * 2005-08-26 2011-06-21 Vertex Pharmaceuticals Incorporated Inhibitors of serine proteases
AR055395A1 (es) * 2005-08-26 2007-08-22 Vertex Pharma Compuestos inhibidores de la actividad de la serina proteasa ns3-ns4a del virus de la hepatitis c
CN102614490A (zh) * 2006-02-27 2012-08-01 弗特克斯药品有限公司 包含vx-950的共晶体和包含所述共晶体的药物组合物
JP5646814B2 (ja) * 2006-03-06 2014-12-24 アッヴィ・インコーポレイテッド Ｈｃｖを治療するためのリトナビルの組成物及び使用方法
JP2009531315A (ja) 2006-03-16 2009-09-03 バーテックス ファーマシューティカルズ インコーポレイテッド 重水素化ｃ型肝炎プロテアーゼインヒビター
AU2007226983A1 (en) * 2006-03-20 2007-09-27 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions
GEP20125378B (en) * 2006-03-20 2012-01-10 Vertex Pharma Pharmaceutical compositions
WO2007120595A2 (en) * 2006-04-11 2007-10-25 Novartis Ag Amines for the treatment of hcv
RU2448976C2 (ru) 2006-04-11 2012-04-27 Новартис Аг Ингибиторы hcv/вич и их применение
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NZ579295A (en) * 2007-02-27 2012-03-30 Vertex Pharma Inhibitors of serine proteases
AP2009004960A0 (en) * 2007-02-27 2009-08-31 Vertex Pharma Co-crystals and pharmaceutical compositions comprising the same
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PT2305263E (pt) * 2007-06-07 2012-10-22 Novartis Ag Formas amorfas estabilizadas de mesilato de imatinib
NZ583699A (en) * 2007-08-30 2012-04-27 Vertex Pharma Co-crystals of vx-950 (telaprevir) other components and pharmaceutical compositions comprising the same
JP5149585B2 (ja) * 2007-10-02 2013-02-20 浜松ホトニクス株式会社 微粒子分散液製造方法
JP5161528B2 (ja) * 2007-10-02 2013-03-13 浜松ホトニクス株式会社 パクリタキセル微粒子、パクリタキセル微粒子分散液、および、これらの製造方法
CN101868452B (zh) * 2007-10-10 2014-08-06 诺华股份有限公司 螺环吡咯烷类与其对抗hcv和hiv感染的应用
AR068916A1 (es) * 2007-10-19 2009-12-16 Abbott Gmbh & Co Kg Producto de dispersion solida que contiene un compuesto a base de n- aril urea
WO2009061395A2 (en) * 2007-11-05 2009-05-14 Vertex Pharmaceuticals Incorporated Hcv combination therapies
US12458635B2 (en) 2008-08-13 2025-11-04 Vertex Pharmaceuticals Incorporated Pharmaceutical composition and administrations thereof
US20100074949A1 (en) 2008-08-13 2010-03-25 William Rowe Pharmaceutical composition and administration thereof
EP2396028A2 (en) 2009-02-12 2011-12-21 Vertex Pharmceuticals Incorporated Hcv combination therapies comprising pegylated interferon, ribavirin and telaprevir
MX349923B (es) 2009-04-03 2017-08-21 Hoffmann La Roche Composiciones del ácido propano-1-sulfónico {3-[5-(4-cloro-fenil)- 1h-pirrolo [2,3-b]-piridina-3-carbonil]-2,4-difluoro-fenil]-amida y el uso de las mismas.
US8512690B2 (en) 2009-04-10 2013-08-20 Novartis Ag Derivatised proline containing peptide compounds as protease inhibitors
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CA2790930A1 (en) * 2010-02-25 2011-09-01 Vereniging Voor Christelijk Hoger Onderwijs, Wetenschappelijk Onderzoek En Patieentenzorg Process for the preparation of .alpha.-acyloxy .beta.-formamido amides
TW201208704A (en) 2010-07-14 2012-03-01 Vertex Pharma Palatable pharmaceutical composition
WO2012109646A1 (en) 2011-02-11 2012-08-16 Vertex Pharmaceuticals Incorporated Treatment of hcv in hiv infection patients
US8409560B2 (en) 2011-03-08 2013-04-02 Zalicus Pharmaceuticals Ltd. Solid dispersion formulations and methods of use thereof
US8466159B2 (en) 2011-10-21 2013-06-18 Abbvie Inc. Methods for treating HCV
SE1450130A1 (sv) 2011-10-21 2014-05-07 Abbvie Inc Förfaranden för att behandla hcv innefattande minst två direktverkande antivirala agenser, ribavirin men inte interferon
SE1450131A1 (sv) 2011-10-21 2014-05-07 Abbvie Inc DAA-kombinationsbehandling (t.ex. med ABT-072 eller ABT-333)för användning vid behandling av HCV
US8492386B2 (en) 2011-10-21 2013-07-23 Abbvie Inc. Methods for treating HCV
US9034832B2 (en) 2011-12-29 2015-05-19 Abbvie Inc. Solid compositions
US20130195797A1 (en) 2012-01-31 2013-08-01 Vertex Pharmaceuticals Incorporated High potency formulations of vx-950
BR112014021090B1 (pt) 2012-02-27 2023-01-24 Vertex Pharmaceuticals Incorporated Composição farmacêutica e uso de n-[2,4-bis(1,1-dimetiletil)-5-hidróxifenil]-1,4-di-hidro-4-oxoquinolina3-carboxamida na preparação da mesma
ITMI20120608A1 (it) * 2012-04-13 2013-10-14 Dipharma Francis Srl Procedimento per la preparazione di un inibitore delle proteasi virali in forma amorfa
WO2013178031A1 (en) * 2012-06-01 2013-12-05 Sunshine Lake Pharma Co., Ltd. New forms of telaprevir and preparation methods thereof
EP2935245A1 (en) * 2012-12-21 2015-10-28 Sandoz AG Novel forms of telaprevir
EP2950786B1 (en) 2013-01-31 2019-11-27 Gilead Pharmasset LLC Combination formulation of two antiviral compounds
BR112015021692A2 (pt) 2013-03-15 2017-07-18 Boehringer Ingelheim Int formulação de dosagem oral sólida de inibidor de hcv no estado amorfo
JP2016529293A (ja) 2013-08-27 2016-09-23 ギリアド ファーマセット エルエルシー ２つの抗ウイルス化合物の組合せ製剤
CN109689063A (zh) 2016-04-28 2019-04-26 埃默里大学 含有炔烃的核苷酸和核苷治疗组合物及其相关用途
CN110193013B (zh) * 2019-07-02 2022-02-08 力品药业(厦门)股份有限公司 一种去乙酰真菌环氧乙酯固体分散体及其制备方法
IL316812A (en) * 2022-05-16 2025-01-01 Day One Biopharmaceuticals Inc PAN-RAF kinase inhibitor oral liquid suspension
JPWO2024080308A1 (enExample) * 2022-10-12 2024-04-18

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WO1997006781A1 (en) * 1995-08-11 1997-02-27 Nissan Chemical Industries, Ltd. Methods for making hardly soluble medicine amorphous
JPH107558A (ja) * 1996-06-19 1998-01-13 Eisai Co Ltd 溶解性改善製剤
WO2002018369A2 (en) * 2000-08-31 2002-03-07 Eli Lilly And Company Peptidomimetic protease inhibitors

Cited By (4)

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JP2014507424A (ja) * 2011-03-08 2014-03-27 ザリカス ファーマスーティカルズ リミテッド 固体分散物製剤およびその使用方法
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IL179809A0 (en) 2007-05-15
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SG153800A1 (en) 2009-07-29
EP1765283A2 (en) 2007-03-28
AU2005253957B2 (en) 2011-08-25
NZ588471A (en) 2012-02-24
IL179809A (en) 2012-10-31
JP2012067138A (ja) 2012-04-05
ZA200802676B (en) 2009-12-30
JP5337262B2 (ja) 2013-11-06
ZA200700030B (en) 2009-06-24
BRPI0511900A (pt) 2008-01-22
TWI389688B (zh) 2013-03-21
AU2005253957A1 (en) 2005-12-29
RU2373923C2 (ru) 2009-11-27
NO20070130L (no) 2007-01-25
CN1988885A (zh) 2007-06-27
WO2005123076A3 (en) 2006-06-15
US20130274180A1 (en) 2013-10-17
WO2005123076A2 (en) 2005-12-29
TW200608975A (en) 2006-03-16
CN102512372A (zh) 2012-06-27
US20060089385A1 (en) 2006-04-27
MXPA06014253A (es) 2007-07-13
KR20120039763A (ko) 2012-04-25
EP1765283A4 (en) 2012-11-28
KR101370580B1 (ko) 2014-03-06
CA2569310A1 (en) 2005-12-29
KR20070030270A (ko) 2007-03-15
RU2006147247A (ru) 2008-07-20

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