WO2004100994A3 - Werfahren zur herstellung einer stabilen injizierbaren formulierung von schwer löslichen antineoplastischen wirkstoffen - Google Patents

Werfahren zur herstellung einer stabilen injizierbaren formulierung von schwer löslichen antineoplastischen wirkstoffen Download PDF

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Publication number
WO2004100994A3
WO2004100994A3 PCT/EP2004/005268 EP2004005268W WO2004100994A3 WO 2004100994 A3 WO2004100994 A3 WO 2004100994A3 EP 2004005268 W EP2004005268 W EP 2004005268W WO 2004100994 A3 WO2004100994 A3 WO 2004100994A3
Authority
WO
WIPO (PCT)
Prior art keywords
dissolve
difficult
production
active substances
injectable formulation
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.)
Ceased
Application number
PCT/EP2004/005268
Other languages
English (en)
French (fr)
Other versions
WO2004100994A2 (de
Inventor
Gerhard Eidenhammer
Heinz Schnait
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ebewe Pharma GmbH Nfg KG
Original Assignee
Ebewe Pharma GmbH Nfg KG
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
Application filed by Ebewe Pharma GmbH Nfg KG filed Critical Ebewe Pharma GmbH Nfg KG
Priority to EP04733335A priority Critical patent/EP1624896B1/de
Priority to US10/540,254 priority patent/US20060263327A1/en
Priority to DE502004009827T priority patent/DE502004009827D1/de
Priority to AT04733335T priority patent/ATE437654T1/de
Publication of WO2004100994A2 publication Critical patent/WO2004100994A2/de
Publication of WO2004100994A3 publication Critical patent/WO2004100994A3/de
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Die Erfindung betrifft ein Verfahren zur Herstellung einer stabilen injizierbaren Formulierung von schwer löslichen antineoplastischen Wirkstoffen, wobei eine Formulierung enthaltend den antineoplastischen Wirkstoff und ein Lösungsmittel und/oder Lösungsmittelsystem, das gegebenenfalls ein Solubilisierungsmittel enthält, mit einem Kationentauscher behandelt wird.
PCT/EP2004/005268 2003-03-19 2004-05-17 Werfahren zur herstellung einer stabilen injizierbaren formulierung von schwer löslichen antineoplastischen wirkstoffen Ceased WO2004100994A2 (de)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP04733335A EP1624896B1 (de) 2003-05-19 2004-05-17 Verfahren zur herstellung einer stabilen injizierbaren formulierung von paclitaxel
US10/540,254 US20060263327A1 (en) 2003-03-19 2004-05-17 Method for the production of a stable injectable formulation made of difficult to dissolve antineoplastic active substances
DE502004009827T DE502004009827D1 (de) 2003-05-19 2004-05-17 Verfahren zur herstellung einer stabilen injizierbaren formulierung von paclitaxel
AT04733335T ATE437654T1 (de) 2003-05-19 2004-05-17 Verfahren zur herstellung einer stabilen injizierbaren formulierung von paclitaxel

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ATA760/2003 2003-05-19
AT7602003 2003-05-19

Publications (2)

Publication Number Publication Date
WO2004100994A2 WO2004100994A2 (de) 2004-11-25
WO2004100994A3 true WO2004100994A3 (de) 2005-05-06

Family

ID=33437385

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/005268 Ceased WO2004100994A2 (de) 2003-03-19 2004-05-17 Werfahren zur herstellung einer stabilen injizierbaren formulierung von schwer löslichen antineoplastischen wirkstoffen

Country Status (5)

Country Link
US (1) US20060263327A1 (de)
EP (1) EP1624896B1 (de)
AT (1) ATE437654T1 (de)
DE (1) DE502004009827D1 (de)
WO (1) WO2004100994A2 (de)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2007219104B2 (en) * 2006-02-21 2010-07-01 Dabur Pharma Limited Stable pharmaceutical composition of taxanes

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0645145A2 (de) * 1993-09-29 1995-03-29 Bristol-Myers Squibb Company Stabilisierte Arzneimittel und stabilisierendes Lösungsmittel
WO1997012017A1 (de) * 1995-09-28 1997-04-03 Basf Aktiengesellschaft Verfahren zur reinigung von alkoxylierten fetten
WO1999033780A1 (en) * 1997-12-24 1999-07-08 Schein Pharmaceutical, Inc. Novel polyethoxylated castor oil, process of making the same and formulations thereof
WO2000023070A1 (en) * 1998-10-20 2000-04-27 Ben Venue Laboratories, Inc. Process for purification of solvents useful in the preparation of pharmaceutical compositions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0645145A2 (de) * 1993-09-29 1995-03-29 Bristol-Myers Squibb Company Stabilisierte Arzneimittel und stabilisierendes Lösungsmittel
WO1997012017A1 (de) * 1995-09-28 1997-04-03 Basf Aktiengesellschaft Verfahren zur reinigung von alkoxylierten fetten
WO1999033780A1 (en) * 1997-12-24 1999-07-08 Schein Pharmaceutical, Inc. Novel polyethoxylated castor oil, process of making the same and formulations thereof
WO2000023070A1 (en) * 1998-10-20 2000-04-27 Ben Venue Laboratories, Inc. Process for purification of solvents useful in the preparation of pharmaceutical compositions

Also Published As

Publication number Publication date
EP1624896B1 (de) 2009-07-29
US20060263327A1 (en) 2006-11-23
DE502004009827D1 (de) 2009-09-10
ATE437654T1 (de) 2009-08-15
EP1624896A2 (de) 2006-02-15
WO2004100994A2 (de) 2004-11-25

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