WO2006030304A3 - Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof - Google Patents

Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof Download PDF

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Publication number
WO2006030304A3
WO2006030304A3 PCT/IB2005/002754 IB2005002754W WO2006030304A3 WO 2006030304 A3 WO2006030304 A3 WO 2006030304A3 IB 2005002754 W IB2005002754 W IB 2005002754W WO 2006030304 A3 WO2006030304 A3 WO 2006030304A3
Authority
WO
WIPO (PCT)
Prior art keywords
fluvastatin sodium
processes
pharmaceutical compositions
preparation
forms
Prior art date
Application number
PCT/IB2005/002754
Other languages
French (fr)
Other versions
WO2006030304A2 (en
Inventor
Shantanu De
Vinayak Tripathi
Swargam Sathyanarayana
Shantanu Jindal
Yatendra Kumar
Original Assignee
Ranbaxy Lab Ltd
Shantanu De
Vinayak Tripathi
Swargam Sathyanarayana
Shantanu Jindal
Yatendra Kumar
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, Shantanu De, Vinayak Tripathi, Swargam Sathyanarayana, Shantanu Jindal, Yatendra Kumar filed Critical Ranbaxy Lab Ltd
Publication of WO2006030304A2 publication Critical patent/WO2006030304A2/en
Publication of WO2006030304A3 publication Critical patent/WO2006030304A3/en

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
    • C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
    • C07D209/18—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
    • C07D209/24—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with an alkyl or cycloalkyl radical attached to the ring nitrogen atom

Abstract

Provided are substantially amorphous fluvastatin sodium and amorphous Form R6 and R-14 of fluvastatin sodium. Also provided are crystalline forms of fluvastatin sodium designated as Forms R-1, R-2, R-3, R-4, R-5, R-7, R-8, R-9, R-10, R-11, R-12, R-13, R-15 and R-16 and an anhydrous crystalline form. Also provided are processes for preparing such polymorphic forms and pharmaceutical compositions thereof. Also provided are methods for antagonizing HMG-CoA comprising administering to a mammal therapeutically effective amounts of the compounds described herein.
PCT/IB2005/002754 2004-09-17 2005-09-16 Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof WO2006030304A2 (en)

Applications Claiming Priority (18)

Application Number Priority Date Filing Date Title
IN1766/DEL/2004 2004-09-17
IN1766DE2004 2004-09-17
IN1848DE2004 2004-09-27
IN1848/DEL/2004 2004-09-27
IN1956/DEL/2004 2004-10-11
IN1958DE2004 2004-10-11
IN1958/DEL/2004 2004-10-11
IN1956DE2004 2004-10-11
IN2168/DEL/2004 2004-10-29
IN2170DE2004 2004-10-29
IN2172/DEL/2004 2004-10-29
IN2170/DEL/2004 2004-10-29
IN2172DE2004 2004-10-29
IN2168DE2004 2004-10-29
IN428DE2005 2005-02-28
IN428/DEL/2005 2005-02-28
IN1703DE2005 2005-06-30
IN1703/DEL/2005 2005-06-30

Publications (2)

Publication Number Publication Date
WO2006030304A2 WO2006030304A2 (en) 2006-03-23
WO2006030304A3 true WO2006030304A3 (en) 2006-12-07

Family

ID=35427294

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2005/002754 WO2006030304A2 (en) 2004-09-17 2005-09-16 Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof

Country Status (1)

Country Link
WO (1) WO2006030304A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1638937E (en) 2003-06-18 2009-01-27 Teva Pharma Fluvastatin sodium crystal form xiv, processes for preparing it, compositions containing it and methods of using it
EP1799641A4 (en) * 2004-10-05 2007-09-19 Biocon Ltd Process for the preparation of amorphous fluvastatin sodium
WO2006109147A1 (en) * 2005-04-12 2006-10-19 Glenmark Pharmaceuticals Limited Substantially pure amorphous fluvastatin, processes for its preparation and pharmaceutical compositions containing same
US20080027125A1 (en) * 2006-02-27 2008-01-31 Tamas Koltai Fluvastatin sodium novel forms and preparation thereof
CN100429202C (en) * 2006-06-30 2008-10-29 浙江新东港药业股份有限公司 Preparation method of amorphous fluvastatin sodium
ES2321571B1 (en) * 2007-07-18 2010-03-11 Ercros Industrial, S.A. SOLVATOS DE FLUVASTATINA SODICA AND ITS USE AS INTERMEDIATE IN OBTAINING FLUVASTATINA SODICA AMORFA.

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4739073A (en) * 1983-11-04 1988-04-19 Sandoz Pharmaceuticals Corp. Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof
US6124340A (en) * 1996-06-24 2000-09-26 Astra Aktiebolag Polymorphic compounds
US20030032666A1 (en) * 2001-08-03 2003-02-13 Van Der Schaaf Paul Adriaan Crystalline forms
WO2003018555A1 (en) * 2001-08-22 2003-03-06 Ciba Speciality Chemicals Holding Inc. Process for the preparation of indole derivatives
US20030166946A1 (en) * 2000-05-26 2003-09-04 Annemarie Wolleb Process for the preparation of indole derivatives and intermediates of the process
WO2004096765A2 (en) * 2003-05-01 2004-11-11 Morepen Laboratories Ltd. A novel crystalline polymorph of fluvastatin sodium and a process for preparing it
US20050032884A1 (en) * 2003-06-18 2005-02-10 Revital Lifshitz-Liron Eluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them
WO2005019170A1 (en) * 2003-08-26 2005-03-03 Biocon Limited Novel process for preparation of 7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl]-3, 5-dihydroxy-6-heptenoic acid sodium salt
WO2005037787A1 (en) * 2003-10-16 2005-04-28 Ciba Specialty Chemicals Holding Inc. Crystalline form of fluvastatin sodium
WO2005080332A1 (en) * 2004-01-14 2005-09-01 Cadila Healthcare Limited Novel form of fluvastatin sodium
US20050209259A1 (en) * 2004-03-17 2005-09-22 Le Huang Novel anhydrous amorphous forms of rosuvastatin calcium, pitavastatin calcium and fluvastatin sodium

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4739073A (en) * 1983-11-04 1988-04-19 Sandoz Pharmaceuticals Corp. Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof
US6124340A (en) * 1996-06-24 2000-09-26 Astra Aktiebolag Polymorphic compounds
US20030166946A1 (en) * 2000-05-26 2003-09-04 Annemarie Wolleb Process for the preparation of indole derivatives and intermediates of the process
US20030032666A1 (en) * 2001-08-03 2003-02-13 Van Der Schaaf Paul Adriaan Crystalline forms
WO2003018555A1 (en) * 2001-08-22 2003-03-06 Ciba Speciality Chemicals Holding Inc. Process for the preparation of indole derivatives
WO2004096765A2 (en) * 2003-05-01 2004-11-11 Morepen Laboratories Ltd. A novel crystalline polymorph of fluvastatin sodium and a process for preparing it
US20050032884A1 (en) * 2003-06-18 2005-02-10 Revital Lifshitz-Liron Eluvastatin sodium crystal forms, processes for preparing them, compositions containing them and methods of using them
WO2005019170A1 (en) * 2003-08-26 2005-03-03 Biocon Limited Novel process for preparation of 7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl]-3, 5-dihydroxy-6-heptenoic acid sodium salt
WO2005037787A1 (en) * 2003-10-16 2005-04-28 Ciba Specialty Chemicals Holding Inc. Crystalline form of fluvastatin sodium
WO2005080332A1 (en) * 2004-01-14 2005-09-01 Cadila Healthcare Limited Novel form of fluvastatin sodium
US20050209259A1 (en) * 2004-03-17 2005-09-22 Le Huang Novel anhydrous amorphous forms of rosuvastatin calcium, pitavastatin calcium and fluvastatin sodium

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
O. REPIC, K. PRASAD, G.T. LEE: "The Story of Lescol: From Research to Production", ORGANIC PROCESS RESEARCH & DEVELOPMENT, vol. 5, 2001, pages 519 - 527, XP002357640 *
TEMPKIN O ET AL: "Asymmetric Synthesis of 3,5-Dihydroxy-6(E)-heptenoate-containing HMG-CoA Reductase Inhibitors", TETRAHEDRON, ELSEVIER SCIENCE PUBLISHERS, AMSTERDAM, NL, vol. 53, no. 31, 4 August 1997 (1997-08-04), pages 10659 - 10670, XP004105948, ISSN: 0040-4020 *

Also Published As

Publication number Publication date
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