DK2279008T3 - Farmaceutiske sammensætninger af paclitaxel, paclitaxel-analoger eller paclitaxel-konjugater og relaterede fremgangsmåder til fremstilling og anvendelse - Google Patents
Farmaceutiske sammensætninger af paclitaxel, paclitaxel-analoger eller paclitaxel-konjugater og relaterede fremgangsmåder til fremstilling og anvendelse Download PDFInfo
- Publication number
- DK2279008T3 DK2279008T3 DK09733078.1T DK09733078T DK2279008T3 DK 2279008 T3 DK2279008 T3 DK 2279008T3 DK 09733078 T DK09733078 T DK 09733078T DK 2279008 T3 DK2279008 T3 DK 2279008T3
- Authority
- DK
- Denmark
- Prior art keywords
- agent
- paclitaxel
- polypeptide
- ang1005
- dmso
- Prior art date
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (13)
1. Lyofiliseret sammensætning omfattende: (a) ANG1005 hvor ANG1005 har strukturen:
(b) et eventuelt tonicitetsmiddel; (c) et buffermiddel; (d) et fyldstof; (e) et opløselighedsfremmende middel, hvor det opløselighedsfremmende middel er en polyoxyethylenester af en fedtsyre; og (f) 0,2 til 10% DMSO.
2. Lyofiliseret sammensætning ifølge krav 1, hvor tonicitetsmiddlet er natriumchlorid; hvor buffermidlet er glycin, citronsyre eller mælkesyre; hvor det opløselighedsfremmende middel er Solutol HS 15; hvor fyldstoffet er mannitol eller sorbitol; hvor mængden af DMSO er mindre end 5%, mere især mindre end 1%, endnu mere især mellem 0,2% og 1,0%; og/eller hvor sammensætningen i alt væsentligt er fri for polyoxyethyleret ricinusolie, især hvor sammensætningen er fri for polyoxyethyleret ricinusolie.
3. Lyofiliseret sammensætning ifølge krav 1 omfattende:
4. Lyofiliseret sammensæting ifølge krav 3 omfattende:
5. Lyofiliseret sammensætning ifølge krav 3 eller 4, hvor tonicitetsmidlet er natriumchlorid, buffermidlet er glycin, og fyldstoffet er mannitol.
6. Lyofiliseret sammensætning ifølge krav 1 omfattende
7. Lyofiliseret sammensætning ifølge krav 6, hvor bufferen er mælkesyre eller citronsyre, og fyldstoffet er mannitol.
8. Lyofiliseret sammensætning ifølge krav 5 til anvendelse i behandlingen af kræft, hvilken fremgangsmåde omfatter indgivelse til en patient, der har behov derfor, af sammensætningen i en mængde, der er tilstrækkelig til at behandle kræften, især hvor kræften er kræft i hjernen, æggestokkene, lungerne, leveren, milten, eller nyrerne, mere især hvor kræft i hjernen er valgt fra gruppen bestående af glioblastom, astrocytom, gliom, meduloblastom, og oligodendrom, neurogliom, ependymom, og meningiom.
9. Forseglet beholder indeholdende den lyofiliserde sammensætning ifølge krav 5.
10. Kit omfattende: (a) den forseglede beholder ifølge krav 5; og (b) anvendelsesinstruktioner.
11. Fremgangsmåde til fremstilling af en lyofiliseret farmaceutisk sammensætning ifølge krav 1, hvilken fremgangsmåde omfatter: (a) at opløse konjugatet i et første opløselighedsfremmende middel for at danne en blanding;
(b) at tilsætte et andet opløselighedsfremmende middel til blandingen fra trin (a); (c) eventuelt at tilsætte vand og et buffermiddel til blandingen; (d) at lyofilisere blandingen fra trin (c); hvor lyofiliseringen resulterer i en reduktion på mindst 20% af mængden af det opløselighedsfremmende middel, men ikke i alt væsentligt reducerer mængden af det andet opløselighedsfremmende middel.
12. Fremgangsmåde ifølge krav 11, hvor det første opløselighedsfremmende middel er DMSO; hvor det andet opløselighedsfremmende middel er en polyoxyethylenester af en fedtsyre, især Solutol HS 15; hvor blandingen fra trin (b) filtreres inden trin (c) lyofilisering; hvor blandingen anbringes i et hætteglas inden trin (c) lyofilisering; hvor fremgangsmåden endvidere omfatter trinnet (e) at opslæmme det lyofiliserede produkt.
13. Fremgangsmåde ifølge krav 12, hvor vand og et buffermiddel tilsættes i trin (c) og trinnet (d) at lyofilisere omfatter: (i) at fryse blandingen; (ii) at tørre det frosne produkt ved en første temperatur og tryk der er tilstrækkelig til at fjerne mindst en del af vandet; og (iii) at tørre produktet ved en anden temperatur og tryk der er tilstrækkelig til at fjerne mindst en del af det første solvent, især hvor det første solvent er DMSO, og det andet solvent er Solutol HS 15.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12467708P | 2008-04-18 | 2008-04-18 | |
PCT/CA2009/000542 WO2009127072A1 (en) | 2008-04-18 | 2009-04-20 | Pharmaceutical compositions of paclitaxel, paclitaxel analogs or paclitaxel conjugates and related methods of preparation and use |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2279008T3 true DK2279008T3 (da) | 2019-04-29 |
Family
ID=41198750
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK09733078.1T DK2279008T3 (da) | 2008-04-18 | 2009-04-20 | Farmaceutiske sammensætninger af paclitaxel, paclitaxel-analoger eller paclitaxel-konjugater og relaterede fremgangsmåder til fremstilling og anvendelse |
Country Status (17)
Country | Link |
---|---|
US (1) | US8710013B2 (da) |
EP (1) | EP2279008B1 (da) |
JP (2) | JP5860698B2 (da) |
CN (1) | CN102026667B (da) |
AU (1) | AU2009238187B2 (da) |
BR (1) | BRPI0910557A2 (da) |
CA (1) | CA2721019C (da) |
DK (1) | DK2279008T3 (da) |
ES (1) | ES2721148T3 (da) |
HK (1) | HK1154795A1 (da) |
MX (1) | MX355683B (da) |
PL (1) | PL2279008T3 (da) |
PT (1) | PT2279008T (da) |
RU (1) | RU2518240C2 (da) |
TR (1) | TR201905480T4 (da) |
WO (1) | WO2009127072A1 (da) |
ZA (1) | ZA201007170B (da) |
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JP2015157825A (ja) | 2015-09-03 |
BRPI0910557A2 (pt) | 2015-09-29 |
JP2011516587A (ja) | 2011-05-26 |
WO2009127072A1 (en) | 2009-10-22 |
TR201905480T4 (tr) | 2019-05-21 |
US20110112036A1 (en) | 2011-05-12 |
CN102026667A (zh) | 2011-04-20 |
EP2279008A4 (en) | 2013-09-04 |
MX355683B (es) | 2018-04-26 |
AU2009238187A1 (en) | 2009-10-22 |
PL2279008T3 (pl) | 2020-03-31 |
US8710013B2 (en) | 2014-04-29 |
CA2721019A1 (en) | 2009-10-22 |
MX2010011339A (es) | 2010-12-21 |
WO2009127072A8 (en) | 2009-12-30 |
CA2721019C (en) | 2015-09-15 |
EP2279008A1 (en) | 2011-02-02 |
ZA201007170B (en) | 2012-01-25 |
HK1154795A1 (en) | 2012-05-04 |
CN102026667B (zh) | 2014-06-25 |
RU2010146718A (ru) | 2012-05-27 |
AU2009238187B2 (en) | 2014-03-06 |
EP2279008B1 (en) | 2019-03-06 |
RU2518240C2 (ru) | 2014-06-10 |
PT2279008T (pt) | 2019-05-20 |
JP5860698B2 (ja) | 2016-02-16 |
ES2721148T3 (es) | 2019-07-29 |
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