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WO2007125521A3 - Polymorphic form of zoledronic acid and processes for their preparation - Google Patents

Polymorphic form of zoledronic acid and processes for their preparation Download PDF

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Publication number
WO2007125521A3
WO2007125521A3 PCT/IB2007/051644 IB2007051644W WO2007125521A3 WO 2007125521 A3 WO2007125521 A3 WO 2007125521A3 IB 2007051644 W IB2007051644 W IB 2007051644W WO 2007125521 A3 WO2007125521 A3 WO 2007125521A3
Authority
WO
WIPO (PCT)
Prior art keywords
zoledronic acid
preparation
processes
polymorphic form
amorphous
Prior art date
Application number
PCT/IB2007/051644
Other languages
French (fr)
Other versions
WO2007125521A2 (en
Inventor
Sushil Raina
Bhupendra Vashishta
Mukesh Kumar Sharma
Medisetti Venkata Ramakrishna
Sanjay Gade
Original Assignee
Ranbaxy Lab Ltd
Sushil Raina
Bhupendra Vashishta
Mukesh Kumar Sharma
Medisetti Venkata Ramakrishna
Sanjay Gade
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 Ranbaxy Lab Ltd, Sushil Raina, Bhupendra Vashishta, Mukesh Kumar Sharma, Medisetti Venkata Ramakrishna, Sanjay Gade filed Critical Ranbaxy Lab Ltd
Publication of WO2007125521A2 publication Critical patent/WO2007125521A2/en
Publication of WO2007125521A3 publication Critical patent/WO2007125521A3/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02—Phosphorus compounds
    • C07F9/547—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
    • C07F9/645—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom having two nitrogen atoms as the only ring hetero atoms
    • C07F9/6503—Five-membered rings
    • C07F9/6506—Five-membered rings having the nitrogen atoms in positions 1 and 3

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

The present invention provides Form A and amorphous form of zoledronic acid. The present invention further provides processes for preparation of Form A, Form I and amorphous zoledronic acid. In addition the present invention provides pharmaceutical compositions comprising the polymorphic form and amorphous zoledronic acid.
PCT/IB2007/051644 2006-05-02 2007-05-02 Polymorphic form of zoledronic acid and processes for their preparation WO2007125521A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1110DE2006 2006-05-02
IN1110/DEL/2006 2006-05-02

Publications (2)

Publication Number Publication Date
WO2007125521A2 WO2007125521A2 (en) 2007-11-08
WO2007125521A3 true WO2007125521A3 (en) 2008-01-10

Family

ID=38332422

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/051644 WO2007125521A2 (en) 2006-05-02 2007-05-02 Polymorphic form of zoledronic acid and processes for their preparation

Country Status (1)

Country Link
WO (1) WO2007125521A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8071574B2 (en) 2005-02-22 2011-12-06 John Dennis Bobyn Implant improving local bone formation

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1925621A1 (en) * 2006-11-27 2008-05-28 Novartis AG Crystalline forms of zoledronic acid
KR101813728B1 (en) 2009-07-31 2017-12-29 그뤼넨탈 게엠베하 Crystallization method and bioavailability
US20160016982A1 (en) 2009-07-31 2016-01-21 Thar Pharmaceuticals, Inc. Crystallization method and bioavailability
US9169279B2 (en) 2009-07-31 2015-10-27 Thar Pharmaceuticals, Inc. Crystallization method and bioavailability
US9340565B2 (en) 2010-11-24 2016-05-17 Thar Pharmaceuticals, Inc. Crystalline forms
US10195218B2 (en) 2016-05-31 2019-02-05 Grunenthal Gmbh Crystallization method and bioavailability

Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4939130A (en) * 1986-11-21 1990-07-03 Ciba-Geigy Corporation Substituted alkanediphosphonic acids and pharmaceutical use
WO2003093282A1 (en) * 2002-04-29 2003-11-13 Chemi S.P.A. Preparation of biphosphonic acids and salts thereof
US20040043967A1 (en) * 2002-05-17 2004-03-04 Rami Lidor-Hadas Novel process for making bisphosphonic acids using diluents other than halogenated hydrocarbons
WO2004075860A2 (en) * 2003-02-27 2004-09-10 Teva Pharmaceutical Industries Ltd. Process for purification of zoledronic acid
US20050054616A1 (en) * 2003-07-03 2005-03-10 Judith Aronhime Zoledronic acid crystal forms, zoledronate sodium salt crystal forms, amorphous zoledronate sodium salt, and processes for their preparation
WO2005044831A2 (en) * 2003-08-21 2005-05-19 Sun Pharmaceutical Industries Limited A process for preparation of bisphosphonic acid compounds
WO2005063779A2 (en) * 2003-12-23 2005-07-14 Lyogen Limited A process for the preparation of alkyl- and aryl-diphosphonic acids and salts thereof
WO2005063717A1 (en) * 2003-12-26 2005-07-14 Natco Pharma Limited An improved process for the preparation of zoledronic acid
WO2005066188A1 (en) * 2003-10-17 2005-07-21 Sun Pharmaceutical Industries Limited A process for the preparation of 2-(imidazol-1-yl)-1-hydroxyethane-1, 1-diphosphonic acid
CN1693308A (en) * 2005-04-15 2005-11-09 扬子江药业集团有限公司 Process for preparing dazoline phospho acid
US20060258625A1 (en) * 2006-02-20 2006-11-16 Alembic Limited Process for the preparation of biphosphonic derivatives
WO2006134603A1 (en) * 2005-06-13 2006-12-21 Jubilant Organosys Limited Process for producing bisphosphonic acids and forms thereof
WO2007016982A1 (en) * 2005-07-28 2007-02-15 Gador S.A. A crystalline form of the zoledronic acid, a process to obtain it and the pharmaceutical composition comprising it
WO2007032808A1 (en) * 2005-09-12 2007-03-22 Dr. Reddy's Laboratories Ltd. Crystalline trihydrate of zoledronic acid
WO2007069049A2 (en) * 2005-12-16 2007-06-21 Wockhardt Ltd Processes for the preparation of pure zoledronic acid

Patent Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4939130A (en) * 1986-11-21 1990-07-03 Ciba-Geigy Corporation Substituted alkanediphosphonic acids and pharmaceutical use
WO2003093282A1 (en) * 2002-04-29 2003-11-13 Chemi S.P.A. Preparation of biphosphonic acids and salts thereof
US20040043967A1 (en) * 2002-05-17 2004-03-04 Rami Lidor-Hadas Novel process for making bisphosphonic acids using diluents other than halogenated hydrocarbons
WO2004075860A2 (en) * 2003-02-27 2004-09-10 Teva Pharmaceutical Industries Ltd. Process for purification of zoledronic acid
US20050054616A1 (en) * 2003-07-03 2005-03-10 Judith Aronhime Zoledronic acid crystal forms, zoledronate sodium salt crystal forms, amorphous zoledronate sodium salt, and processes for their preparation
WO2005044831A2 (en) * 2003-08-21 2005-05-19 Sun Pharmaceutical Industries Limited A process for preparation of bisphosphonic acid compounds
WO2005066188A1 (en) * 2003-10-17 2005-07-21 Sun Pharmaceutical Industries Limited A process for the preparation of 2-(imidazol-1-yl)-1-hydroxyethane-1, 1-diphosphonic acid
WO2005063779A2 (en) * 2003-12-23 2005-07-14 Lyogen Limited A process for the preparation of alkyl- and aryl-diphosphonic acids and salts thereof
WO2005063717A1 (en) * 2003-12-26 2005-07-14 Natco Pharma Limited An improved process for the preparation of zoledronic acid
CN1693308A (en) * 2005-04-15 2005-11-09 扬子江药业集团有限公司 Process for preparing dazoline phospho acid
WO2006134603A1 (en) * 2005-06-13 2006-12-21 Jubilant Organosys Limited Process for producing bisphosphonic acids and forms thereof
WO2007016982A1 (en) * 2005-07-28 2007-02-15 Gador S.A. A crystalline form of the zoledronic acid, a process to obtain it and the pharmaceutical composition comprising it
WO2007032808A1 (en) * 2005-09-12 2007-03-22 Dr. Reddy's Laboratories Ltd. Crystalline trihydrate of zoledronic acid
WO2007069049A2 (en) * 2005-12-16 2007-06-21 Wockhardt Ltd Processes for the preparation of pure zoledronic acid
US20060258625A1 (en) * 2006-02-20 2006-11-16 Alembic Limited Process for the preparation of biphosphonic derivatives

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
DATABASE CA [online] CHEMICAL ABSTRACTS SERVICE, COLUMBUS, OHIO, US; CAI, WEI ET AL: "Preparation of zoledronic acid from imidazole", XP002447128, retrieved from STN Database accession no. 2006:708301 *
SANDERS, JOHN M. ET AL: "3-D QSAR Investigations of the Inhibition of Leishmania major Farnesyl Pyrophosphate Synthase by Bisphosphonates", JOURNAL OF MEDICINAL CHEMISTRY , 46(24), 5171-5183 CODEN: JMCMAR; ISSN: 0022-2623, 2003, XP002447558 *
ZHU J ET AL: "SYNTHESIS OF ZOLEDRONIC ACID", ZHONGGUO XIN YAO ZAZHI - CHINESE NEW DRUGS JOURNAL, GAI-KAN BIANJIBU, BEIJING, CN, vol. 12, no. 1, January 2003 (2003-01-01), pages 39 - 40, XP001204255, ISSN: 1003-3734 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8071574B2 (en) 2005-02-22 2011-12-06 John Dennis Bobyn Implant improving local bone formation

Also Published As

Publication number Publication date
WO2007125521A2 (en) 2007-11-08

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