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IN2012DE00337A - - Google Patents

Info

Publication number
IN2012DE00337A
IN2012DE00337A IN337DE2012A IN2012DE00337A IN 2012DE00337 A IN2012DE00337 A IN 2012DE00337A IN 337DE2012 A IN337DE2012 A IN 337DE2012A IN 2012DE00337 A IN2012DE00337 A IN 2012DE00337A
Authority
IN
India
Prior art keywords
addition
hydrolysis
organic solvent
solution
required quantity
Prior art date
Application number
Inventor
Dhiraj Khattar
Rajesh; Khanna
Sanjay Motwani
Minakshi; Garg
Vikas Chandel
Mukti; Yadav
Kyama Vijay Kumar
Vikas; Bhandari
Original Assignee
Fresenius Kabi Oncology Ltd
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 Fresenius Kabi Oncology Ltd filed Critical Fresenius Kabi Oncology Ltd
Priority to IN337DE2012 priority Critical patent/IN2012DE00337A/en
Priority to US14/377,047 priority patent/US9872873B2/en
Priority to PCT/IB2012/051513 priority patent/WO2013117969A1/en
Priority to EP12719066.8A priority patent/EP2811984B1/en
Publication of IN2012DE00337A publication Critical patent/IN2012DE00337A/en

Links

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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds 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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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

Landscapes

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

Abstract

The present invention relates to a process of preparing a stable pharmaceutical composition of compounds which are susceptible to hydrolysis comprising a. Addition of required quantity of pharmaceutically acceptable lyophilization excipients optionally in Water for Injection in a formulation vessel; b. Addition of organic solvent to form a appropriate proportion of aqueous and organic solvent; c. Maintaining the temperature of the formulation vessel from the range -5±1°C to - 5±3°C; d. Addition of required quantity of compound susceptible to hydrolysis to form a solution and lyophilizing the solution.
IN337DE2012 2012-02-06 2012-03-29 IN2012DE00337A (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
IN337DE2012 IN2012DE00337A (en) 2012-02-06 2012-03-29
US14/377,047 US9872873B2 (en) 2012-02-06 2012-03-29 Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis
PCT/IB2012/051513 WO2013117969A1 (en) 2012-02-06 2012-03-29 Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis
EP12719066.8A EP2811984B1 (en) 2012-02-06 2012-03-29 Process for preparing stable pharmaceutical compositions of compounds susceptible to hydrolysis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN337DE2012 IN2012DE00337A (en) 2012-02-06 2012-03-29

Publications (1)

Publication Number Publication Date
IN2012DE00337A true IN2012DE00337A (en) 2015-04-10

Family

ID=46028019

Family Applications (1)

Application Number Title Priority Date Filing Date
IN337DE2012 IN2012DE00337A (en) 2012-02-06 2012-03-29

Country Status (4)

Country Link
US (1) US9872873B2 (en)
EP (1) EP2811984B1 (en)
IN (1) IN2012DE00337A (en)
WO (1) WO2013117969A1 (en)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7700567B2 (en) 2005-09-29 2010-04-20 Supergen, Inc. Oligonucleotide analogues incorporating 5-aza-cytosine therein
EP3431142B1 (en) 2011-08-30 2020-06-17 Astex Pharmaceuticals, Inc. Decitabine derivative formulations
US9801859B2 (en) * 2012-09-18 2017-10-31 Innopharma Licensing, Llc Bendamustine formulations
US9765108B2 (en) 2012-11-19 2017-09-19 Shilpa Medicare Limited Formulation of 5-azacytidine
US9849115B2 (en) 2013-08-27 2017-12-26 Vasilios Voudouris Bendamustine pharmaceutical compositions
CN103585168A (en) * 2013-11-27 2014-02-19 哈尔滨誉衡药业股份有限公司 Medicine composition containing gemcitabine hydrochloride
CN104739778A (en) * 2013-12-26 2015-07-01 山东新时代药业有限公司 Azacitidine for injection, and preparation method thereof
EP3116481A1 (en) 2014-03-13 2017-01-18 Vasilios VOUDOURIS Bendamustine solid dispersions and continuous infusion
US20160095925A1 (en) * 2014-10-01 2016-04-07 Cadila Healthcare Limited Stable formulation of azacitidine or salts thereof and their process for preparation
US10485764B2 (en) * 2015-07-02 2019-11-26 Otsuka Pharmaceutical Co., Ltd. Lyophilized pharmaceutical compositions
CN105769775A (en) * 2016-03-24 2016-07-20 浙江华海药业股份有限公司 Preparation method of azacitidine for injection
MX2020001233A (en) 2017-08-03 2020-07-20 Otsuka Pharma Co Ltd Drug compound and purification methods thereof.
CN108295034A (en) * 2018-03-29 2018-07-20 健进制药有限公司 A kind of injection azacitidine freeze-dried powder and preparation method thereof
KR20190136284A (en) * 2018-05-30 2019-12-10 주식회사 삼양바이오팜 Method for preparing stable azacitidine-containing pharmaceutical composition
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4684630A (en) 1983-08-24 1987-08-04 Repta Arnold J Method of parenterally delivering drugs and related compositions
JP2007500191A (en) 2003-07-25 2007-01-11 ワイス Freeze-dried formulation of CCI-779
US20060069060A1 (en) * 2004-09-27 2006-03-30 Sanjeev Redkar Salts of decitabine
US8436190B2 (en) 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
CN101361718B (en) 2008-09-26 2013-08-28 深圳万乐药业有限公司 Stable preparation method of decitabine freeze-dry preparation
CN101584670B (en) 2009-06-19 2011-04-20 江苏奥赛康药业有限公司 Decitabine freeze-dried powder injection
US20110042247A1 (en) 2009-06-25 2011-02-24 Chandrasekhar Kocherlakota Formulations of azacitidine and its derivatives
WO2011014541A1 (en) 2009-07-30 2011-02-03 Eagle Pharmaceuticals, Inc. Stable formulations of azacitidine
WO2011103150A2 (en) 2010-02-18 2011-08-25 Cephalon, Inc. Lyophilized preparations of bendamustine
US20140142153A1 (en) * 2011-01-25 2014-05-22 Dr. Reddy's Laboratories, Inc. Bendamustine formulations

Also Published As

Publication number Publication date
WO2013117969A1 (en) 2013-08-15
EP2811984B1 (en) 2015-08-26
US20140378407A1 (en) 2014-12-25
EP2811984A1 (en) 2014-12-17
US9872873B2 (en) 2018-01-23

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