WO2010046917A3 - Fludarabine phosphate composition - Google Patents

Fludarabine phosphate composition Download PDF

Info

Publication number
WO2010046917A3
WO2010046917A3 PCT/IN2009/000556 IN2009000556W WO2010046917A3 WO 2010046917 A3 WO2010046917 A3 WO 2010046917A3 IN 2009000556 W IN2009000556 W IN 2009000556W WO 2010046917 A3 WO2010046917 A3 WO 2010046917A3
Authority
WO
WIPO (PCT)
Prior art keywords
fludarabine phosphate
phosphate composition
present invention
composition
stable
Prior art date
Application number
PCT/IN2009/000556
Other languages
French (fr)
Other versions
WO2010046917A2 (en
Inventor
Bothra Mukesh
Patel Bhavesh
Sehgal Ashish
Kumar Mandal Jayanta
Original Assignee
Intas Pharmaceuticals Limited
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 IN2182MU2008 priority Critical
Priority to IN2182/MUM/2008 priority
Application filed by Intas Pharmaceuticals Limited filed Critical Intas Pharmaceuticals Limited
Publication of WO2010046917A2 publication Critical patent/WO2010046917A2/en
Publication of WO2010046917A3 publication Critical patent/WO2010046917A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7076Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Abstract

The invention is directed to a stable injectable ready-to-use (RTU) aqueous fludarabine phosphate composition. Fludarabine phosphate composition of the present invention comprises of fludarabine phosphate, a buffer and water for injection. Fludarabine phosphate composition of the present invention is stable against the transient exposure to elevated temperatures.
PCT/IN2009/000556 2008-10-13 2009-10-08 Fludarabine phosphate composition WO2010046917A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
IN2182MU2008 2008-10-13
IN2182/MUM/2008 2008-10-13

Publications (2)

Publication Number Publication Date
WO2010046917A2 WO2010046917A2 (en) 2010-04-29
WO2010046917A3 true WO2010046917A3 (en) 2010-06-24

Family

ID=41719107

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2009/000556 WO2010046917A2 (en) 2008-10-13 2009-10-08 Fludarabine phosphate composition

Country Status (1)

Country Link
WO (1) WO2010046917A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104771369A (en) * 2014-01-09 2015-07-15 山东新时代药业有限公司 Fludarabine phosphate freeze-dried powder injection
CN106265499A (en) * 2016-09-18 2017-01-04 天津金耀药业有限公司 Composite potassium hydrogen phosphate injection pharmaceutical composition

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6287602B1 (en) * 1998-09-16 2001-09-11 Oncopharmaceutical, Inc. Treatment of oncologic tumors with an injectable formulation of a Golgi apparatus disturbing agent
WO2003099007A1 (en) * 2002-05-24 2003-12-04 Sicor Inc. Aqueous fludarabine phosphate composition

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5081110A (en) 1986-03-27 1992-01-14 Sloan-Kettering Institute For Cancer Research Method of killing sarcoma cells using fludarabine phosphate and ionizing radiation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6287602B1 (en) * 1998-09-16 2001-09-11 Oncopharmaceutical, Inc. Treatment of oncologic tumors with an injectable formulation of a Golgi apparatus disturbing agent
WO2003099007A1 (en) * 2002-05-24 2003-12-04 Sicor Inc. Aqueous fludarabine phosphate composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
James Swarbrick: "Encyclopedia of Pharmaceutical Technology" 2007, , XP002571441 vol. 3, , page 1627 the whole document *

Also Published As

Publication number Publication date
WO2010046917A2 (en) 2010-04-29

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