WO2006133835A8 - Formulation pharmaceutique du compose indibuline inhibiteur de la tubuline s'administrant par voie orale et possedant des proprietes pharmacocinetiques ameliorees, et procede de fabrication de cette formulation - Google Patents

Formulation pharmaceutique du compose indibuline inhibiteur de la tubuline s'administrant par voie orale et possedant des proprietes pharmacocinetiques ameliorees, et procede de fabrication de cette formulation Download PDF

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Publication number
WO2006133835A8
WO2006133835A8 PCT/EP2006/005423 EP2006005423W WO2006133835A8 WO 2006133835 A8 WO2006133835 A8 WO 2006133835A8 EP 2006005423 W EP2006005423 W EP 2006005423W WO 2006133835 A8 WO2006133835 A8 WO 2006133835A8
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
tubulin inhibitor
solid pharmaceutical
oral solid
indibulin
Prior art date
Application number
PCT/EP2006/005423
Other languages
English (en)
Other versions
WO2006133835A2 (fr
WO2006133835A3 (fr
Inventor
Berthold Roessler
Gerhard Raab
Thomas Reissmann
Original Assignee
Ziopharm Oncology, 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
Priority to AU2006257428A priority Critical patent/AU2006257428B2/en
Priority to DE602006004365T priority patent/DE602006004365D1/de
Application filed by Ziopharm Oncology, Inc. filed Critical Ziopharm Oncology, Inc.
Priority to EP06761981A priority patent/EP1922061B8/fr
Priority to NZ564927A priority patent/NZ564927A/en
Priority to CA002612288A priority patent/CA2612288A1/fr
Priority to DK06761981T priority patent/DK1922061T3/da
Priority to JP2008516177A priority patent/JP2008543798A/ja
Priority to MX2007016081A priority patent/MX2007016081A/es
Priority to CN2006800278114A priority patent/CN101277681B/zh
Priority to BRPI0613139-5A priority patent/BRPI0613139A2/pt
Publication of WO2006133835A2 publication Critical patent/WO2006133835A2/fr
Publication of WO2006133835A3 publication Critical patent/WO2006133835A3/fr
Priority to IL188164A priority patent/IL188164A/en
Priority to NO20076509A priority patent/NO20076509L/no
Priority to HK08112664.2A priority patent/HK1120739A1/xx
Publication of WO2006133835A8 publication Critical patent/WO2006133835A8/fr

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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
    • A61K9/1617—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
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

L'invention concerne une formulation pharmaceutique pour l'administration par voie orale du composé indibuline, inhibiteur de la tubuline, qui est peu soluble et présente par conséquent une faible biodisponibilité, et un procédé de fabrication de cette formulation. Elle concerne en particulier une formulation pharmaceutique de l'indibuline s'administrant par voie orale, qui comprend un granulé renfermant de l'indibuline micronisée dont la taille des particules est inférieure à 20 µm pour au moins 99 % en volume des particules, au moins un tensioactif hydrophile et un ou plusieurs excipients d'encapsulation.
PCT/EP2006/005423 2005-06-14 2006-06-07 Formulation pharmaceutique du compose indibuline inhibiteur de la tubuline s'administrant par voie orale et possedant des proprietes pharmacocinetiques ameliorees, et procede de fabrication de cette formulation WO2006133835A2 (fr)

Priority Applications (13)

Application Number Priority Date Filing Date Title
CN2006800278114A CN101277681B (zh) 2005-06-14 2006-06-07 微管蛋白抑制剂吲地布林的口服固体药物制剂
MX2007016081A MX2007016081A (es) 2005-06-14 2006-06-07 Formulacion farmaceutica del inhibidor de tubulina, indibulina, para administracion oral con propiedades farmacocineticas mejoradas, y proceso para la fabricacion de la misma.
EP06761981A EP1922061B8 (fr) 2005-06-14 2006-06-07 Formulation solide pharmaceutique orale du compose indibuline inhibiteur de la tubuline
DE602006004365T DE602006004365D1 (de) 2005-06-14 2006-06-07 Feste orale darreichungsform des tribulinhemmstoffs indibulin
CA002612288A CA2612288A1 (fr) 2005-06-14 2006-06-07 Formulation pharmaceutique du compose indibuline inhibiteur de la tubuline s'administrant par voie orale et possedant des proprietes pharmacocinetiques ameliorees, et procede de fabrication de cette formulation
DK06761981T DK1922061T3 (da) 2005-06-14 2006-06-07 Oral, fast farmaceutisk formulering af tribulininhibitoren Indibulin
BRPI0613139-5A BRPI0613139A2 (pt) 2005-06-14 2006-06-07 formulação farmacêutica do inibidor de tubulina indibulina para administração oral com aperfeiçoadas propriedades fármaco-cinéticas, e processo para sua fabricação
AU2006257428A AU2006257428B2 (en) 2005-06-14 2006-06-07 Oral solid pharmaceutical formulation of the tubulin inhibitor indibulin
NZ564927A NZ564927A (en) 2005-06-14 2006-06-07 Pharmaceutical formulation of the tubulin inhibitor Indibulin for oral administration with improved pharmacokinetic properties, and process for the manufacture thereof
JP2008516177A JP2008543798A (ja) 2005-06-14 2006-06-07 チューブリンインヒビターであるインジブリン（Ｉｎｄｉｂｕｌｉｎ）の改良された薬物動態学を有する、経口投与のための薬剤組成物、及びその製造法
IL188164A IL188164A (en) 2005-06-14 2007-12-16 Pharmaceutical formulation of the tubulin inhibitor indibulin for oral administration with improved pharmacokinetic properties and process for the manufacture thereof
NO20076509A NO20076509L (no) 2005-06-14 2007-12-19 Farmasoytiske formuleringer av tubulin-inhibitoren Indibulin for oral administrering med forbedrede farmakokinetiske egenskaper, samt fremgangsmater for deres fremstilling
HK08112664.2A HK1120739A1 (en) 2005-06-14 2008-11-19 Oral solid pharmaceutical formulation of the tribulin inhibitor indibulin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/151,459 2005-06-14
US11/151,459 US20060280787A1 (en) 2005-06-14 2005-06-14 Pharmaceutical formulation of the tubulin inhibitor indibulin for oral administration with improved pharmacokinetic properties, and process for the manufacture thereof

Publications (3)

Publication Number Publication Date
WO2006133835A2 WO2006133835A2 (fr) 2006-12-21
WO2006133835A3 WO2006133835A3 (fr) 2007-07-19
WO2006133835A8 true WO2006133835A8 (fr) 2010-05-27

Family

ID=37524356

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/005423 WO2006133835A2 (fr) 2005-06-14 2006-06-07 Formulation pharmaceutique du compose indibuline inhibiteur de la tubuline s'administrant par voie orale et possedant des proprietes pharmacocinetiques ameliorees, et procede de fabrication de cette formulation

Country Status (21)

Country Link
US (1) US20060280787A1 (fr)
EP (1) EP1922061B8 (fr)
JP (2) JP2008543798A (fr)
KR (1) KR20080045110A (fr)
CN (1) CN101277681B (fr)
AT (1) ATE417603T1 (fr)
AU (1) AU2006257428B2 (fr)
BR (1) BRPI0613139A2 (fr)
CA (1) CA2612288A1 (fr)
DE (1) DE602006004365D1 (fr)
DK (1) DK1922061T3 (fr)
ES (1) ES2319929T3 (fr)
HK (1) HK1120739A1 (fr)
IL (1) IL188164A (fr)
MX (1) MX2007016081A (fr)
NO (1) NO20076509L (fr)
NZ (1) NZ564927A (fr)
PT (1) PT1922061E (fr)
RU (1) RU2008100236A (fr)
WO (1) WO2006133835A2 (fr)
ZA (1) ZA200711169B (fr)

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TW201113266A (en) * 2009-09-02 2011-04-16 Ziopharm Oncology Inc Pharmaceutical formulations for indibulin

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AU2006257428A1 (en) 2006-12-21
ATE417603T1 (de) 2009-01-15
PT1922061E (pt) 2009-03-24
EP1922061A2 (fr) 2008-05-21
NZ564927A (en) 2010-12-24
WO2006133835A2 (fr) 2006-12-21
JP2013151574A (ja) 2013-08-08
WO2006133835A3 (fr) 2007-07-19
DE602006004365D1 (de) 2009-01-29
JP2008543798A (ja) 2008-12-04
CA2612288A1 (fr) 2006-12-21
DK1922061T3 (da) 2009-04-20
IL188164A0 (en) 2008-03-20
KR20080045110A (ko) 2008-05-22
NO20076509L (no) 2008-02-27
ZA200711169B (en) 2009-01-28
AU2006257428B2 (en) 2012-03-22
EP1922061B8 (fr) 2010-09-08
ES2319929T3 (es) 2009-05-14
CN101277681B (zh) 2013-03-20
IL188164A (en) 2010-11-30
RU2008100236A (ru) 2009-07-20
EP1922061B1 (fr) 2008-12-17
CN101277681A (zh) 2008-10-01
HK1120739A1 (en) 2009-04-09
US20060280787A1 (en) 2006-12-14
MX2007016081A (es) 2008-03-10
BRPI0613139A2 (pt) 2010-12-21

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