WO2007074475A3 - Novel polymorphic forms of ibandronate - Google Patents

Novel polymorphic forms of ibandronate Download PDF

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Publication number
WO2007074475A3
WO2007074475A3 PCT/IN2006/000501 IN2006000501W WO2007074475A3 WO 2007074475 A3 WO2007074475 A3 WO 2007074475A3 IN 2006000501 W IN2006000501 W IN 2006000501W WO 2007074475 A3 WO2007074475 A3 WO 2007074475A3
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WO
WIPO (PCT)
Prior art keywords
ibandronate
polymorphic forms
novel polymorphic
novel
monosodium monohydrate
Prior art date
Application number
PCT/IN2006/000501
Other languages
French (fr)
Other versions
WO2007074475A2 (en
Inventor
Reddy Muddasani Pulla
Vattikuti Usharani
Chowdary Nannapaneni Venkaiah
Original Assignee
Natco Pharma Ltd
Reddy Muddasani Pulla
Vattikuti Usharani
Chowdary Nannapaneni Venkaiah
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 Natco Pharma Ltd, Reddy Muddasani Pulla, Vattikuti Usharani, Chowdary Nannapaneni Venkaiah filed Critical Natco Pharma Ltd
Publication of WO2007074475A2 publication Critical patent/WO2007074475A2/en
Publication of WO2007074475A3 publication Critical patent/WO2007074475A3/en

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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
    • C07F9/28—Phosphorus compounds with one or more P—C bonds
    • C07F9/38—Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)]
    • C07F9/3804—Phosphonic acids [RP(=O)(OH)2]; Thiophosphonic acids ; [RP(=X1)(X2H)2(X1, X2 are each independently O, S or Se)] not used, see subgroups
    • C07F9/3839—Polyphosphonic acids
    • C07F9/3873—Polyphosphonic acids containing nitrogen substituent, e.g. N.....H or N-hydrocarbon group which can be substituted by halogen or nitro(so), N.....O, N.....S, N.....C(=X)- (X =O, S), N.....N, N...C(=X)...N (X =O, S)

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  • 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)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to novel and stable polymorphic forms of ibandronate monosodium monohydrate of formula I and processes for their preparation. Ibandronate monosodium monohydrate is useful, as bone resorption inhibitor. The novel crystalline forms are designated as Form I, Form II and the amorphous ibandronate monosodium monohydrate as Form III.
PCT/IN2006/000501 2005-12-27 2006-12-21 Novel polymorphic forms of ibandronate WO2007074475A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1936/CHE/2005 2005-12-27
IN1936CH2005 2005-12-27

Publications (2)

Publication Number Publication Date
WO2007074475A2 WO2007074475A2 (en) 2007-07-05
WO2007074475A3 true WO2007074475A3 (en) 2007-09-07

Family

ID=37890132

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2006/000501 WO2007074475A2 (en) 2005-12-27 2006-12-21 Novel polymorphic forms of ibandronate

Country Status (1)

Country Link
WO (1) WO2007074475A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2576659A1 (en) 2004-08-23 2006-03-02 Teva Pharmaceutical Industries Ltd. Solid and crystalline ibandronate sodium and processes for preparation thereof
EP2046342A4 (en) * 2006-07-28 2011-05-04 Reddys Lab Ltd Dr Crystalline form a of ibandronic acid and process for the preparation
AU2008242788A1 (en) 2007-04-19 2008-10-30 Dr. Reddy's Laboratories Ltd. Ibandronate sodium polymorphs
US20090099390A1 (en) * 2007-09-24 2009-04-16 Teva Pharmaceutical Industries Ltd. Crystalline forms of ibandronic acid and processes for the preparation thereof
EP2128166A1 (en) 2008-05-20 2009-12-02 Chemo Ibérica, S.A. Polymorphic forms of Ibandronate sodium and processes for preparation thereof
WO2009053445A2 (en) * 2007-10-26 2009-04-30 Chemo Ibérica, S.A. Polymorphic forms of ibandronate sodium and processes for preparation thereof
TR201110524A2 (en) * 2011-01-06 2012-07-23 Bi̇lgi̇ç Mahmut New water-soluble formulations for use in the treatment of bone diseases.
TR201200588A2 (en) * 2012-01-18 2012-07-23 Koçak Farma İlaç Ve Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇ Processes for preparing sodium ibandronate monohydrate polymorphs and mixtures with polymorphs.
WO2013179305A1 (en) * 2012-06-01 2013-12-05 Hetero Research Foundation Ibandronate sodium solid dispersion

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927814A (en) * 1986-07-11 1990-05-22 Boehringer Mannheim Gmbh Diphosphonate derivatives, pharmaceutical compositions and methods of use
WO2001052859A1 (en) * 2000-01-20 2001-07-26 F. Hoffmann-La Roche Ag Pharmaceutical parenteral composition containing a biphosphonate
WO2006002348A2 (en) * 2004-06-23 2006-01-05 Teva Pharmaceutical Industies Ltd. Solid and crystalline ibandronic acid
WO2006024024A2 (en) * 2004-08-23 2006-03-02 Teva Pharmaceutical Industries Ltd. Solid and crystalline ibandronate sodium and processes for preparation thereof
WO2006045578A2 (en) * 2004-10-29 2006-05-04 F. Hoffmann-La Roche Ag Process for the preparation of ibandronate
WO2006081962A1 (en) * 2005-02-01 2006-08-10 F.Hoffmann-La Roche Ag Ibandronate polymorph b
WO2006081963A1 (en) * 2005-02-01 2006-08-10 F.Hoffmann-La Roche Ag Ibandronate polymorph a
WO2007013097A1 (en) * 2005-07-25 2007-02-01 Natco Pharma Limited Improved process for the preparation of ibandronate sodium

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4927814A (en) * 1986-07-11 1990-05-22 Boehringer Mannheim Gmbh Diphosphonate derivatives, pharmaceutical compositions and methods of use
WO2001052859A1 (en) * 2000-01-20 2001-07-26 F. Hoffmann-La Roche Ag Pharmaceutical parenteral composition containing a biphosphonate
WO2006002348A2 (en) * 2004-06-23 2006-01-05 Teva Pharmaceutical Industies Ltd. Solid and crystalline ibandronic acid
WO2006024024A2 (en) * 2004-08-23 2006-03-02 Teva Pharmaceutical Industries Ltd. Solid and crystalline ibandronate sodium and processes for preparation thereof
WO2006045578A2 (en) * 2004-10-29 2006-05-04 F. Hoffmann-La Roche Ag Process for the preparation of ibandronate
WO2006081962A1 (en) * 2005-02-01 2006-08-10 F.Hoffmann-La Roche Ag Ibandronate polymorph b
WO2006081963A1 (en) * 2005-02-01 2006-08-10 F.Hoffmann-La Roche Ag Ibandronate polymorph a
WO2007013097A1 (en) * 2005-07-25 2007-02-01 Natco Pharma Limited Improved process for the preparation of ibandronate sodium

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CENTER FOR DRUG EVALUATION AND RESEARCH, 2 July 2003 (2003-07-02), XP002427783, Retrieved from the Internet <URL:http://www.fda.gov/cder/foi/nda/2003/21-455_Boniva.htm> [retrieved on 20070403] *
DUU-GONG WU: "BONIVA (ibandronate sodium) Tablets 2.5 mg", CHEMISTRY REVIEW, 2 July 2003 (2003-07-02), XP002427781, Retrieved from the Internet <URL:http://www.fda.gov/cder/foi/nda/2003/21-455_Boniva_chemr.pdf> [retrieved on 20070403] *
ROCHE: "BONIVA(R) F. C. Tablets (150 mg)", MATERIAL SAFETY DATA SHEET, 7 April 2005 (2005-04-07), XP002427782, Retrieved from the Internet <URL:http://www.msds-gsk.com/13025801.pdf> [retrieved on 20070403] *

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Publication number Publication date
WO2007074475A2 (en) 2007-07-05

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