ES2543804T3 - Polimorfo B de Ibandronato - Google Patents

Polimorfo B de Ibandronato Download PDF

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Publication number
ES2543804T3
ES2543804T3 ES06701843.2T ES06701843T ES2543804T3 ES 2543804 T3 ES2543804 T3 ES 2543804T3 ES 06701843 T ES06701843 T ES 06701843T ES 2543804 T3 ES2543804 T3 ES 2543804T3
Authority
ES
Spain
Prior art keywords
hydroxypropane
pentyl
acetone
amino
methyl
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES06701843.2T
Other languages
English (en)
Inventor
Uwe Eiermann
Bernd Junghans
Bernhard Knipp
Tim Sattelkau
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36088250&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2543804(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2543804T3 publication Critical patent/ES2543804T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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)]
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Rheumatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Analysing Materials By The Use Of Radiation (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

Procedimiento para la preparación de un polimorfo cristalino de monohidrato de sal monosódica (Ibandronato) del ácido 3-(N-metil-N-pentil) amino-1-hidroxipropano-1,1-difosfónico que se caracteriza con un patrón de difracción de rayos X de polvos, teniendo los picos característicos que se expresan en el ángulo 2-theta a aproximadamente +- 0,2 grados Ángulo 2-theta 9,7º 12,2º 14,4º 16,8º 25,8º que comprende la cristalización de sal monosódica del ácido 3-(N-metil-N-pentil) amino-1-hidroxipropano-1,1- difosfónico o un monohidrato, un polimorfo o una mezcla de los mimos polimorfos a una temperatura de 10°C a 45°C en un solvente polar que es agua y con la adición de un solvente aprótico polar que es acetona para iniciar la cristalización, en donde el precipitado se lava con una mezcla de agua y acetona en una proporción de aproximadamente 1:1 (V/V).

Description

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Claims (1)

  1. imagen1
ES06701843.2T 2005-02-01 2006-01-24 Polimorfo B de Ibandronato Expired - Lifetime ES2543804T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP05100687 2005-02-01
EP05100687 2005-02-01
PCT/EP2006/000579 WO2006081962A1 (en) 2005-02-01 2006-01-24 Ibandronate polymorph b

Publications (1)

Publication Number Publication Date
ES2543804T3 true ES2543804T3 (es) 2015-08-24

Family

ID=36088250

Family Applications (1)

Application Number Title Priority Date Filing Date
ES06701843.2T Expired - Lifetime ES2543804T3 (es) 2005-02-01 2006-01-24 Polimorfo B de Ibandronato

Country Status (20)

Country Link
US (2) US7582789B2 (es)
EP (3) EP2363401A1 (es)
JP (2) JP5828607B2 (es)
KR (1) KR100908530B1 (es)
CN (1) CN101111505B (es)
AR (1) AR053119A1 (es)
AU (1) AU2006210008B2 (es)
BR (1) BRPI0607093A2 (es)
CA (1) CA2594717C (es)
DK (1) DK1848727T3 (es)
ES (1) ES2543804T3 (es)
IL (1) IL184720A (es)
MX (1) MX2007008917A (es)
NO (1) NO20073755L (es)
PL (1) PL1848727T3 (es)
RU (1) RU2387661C2 (es)
SI (1) SI1848727T1 (es)
TW (1) TWI374888B (es)
WO (1) WO2006081962A1 (es)
ZA (1) ZA200706170B (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE602005025977D1 (de) 2004-08-23 2011-03-03 Teva Pharma Kristalline form des ibandronat-natriums und herstellungsverfahren dafür
JP5828607B2 (ja) 2005-02-01 2015-12-09 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ イバンドロネート多形ｂ
WO2007074475A2 (en) * 2005-12-27 2007-07-05 Natco Pharma Limited Novel polymorphic forms of ibandronate
PT103600B (pt) * 2006-11-06 2009-01-30 Hovione Farmaciencia Sa Processo para a preparação de ácidos biosfónicos e seus sais farmaceuticamente aceitáveis
US20090012047A1 (en) * 2006-11-16 2009-01-08 Eran Turgeman Crystalline forms of ibandronate sodium
CN101679465B (zh) * 2007-04-11 2013-08-21 霍夫曼-拉罗奇有限公司 伊班膦酸盐的制备方法
KR20100014728A (ko) * 2007-04-19 2010-02-10 닥터 레디스 레보러터리즈 리미티드 이반드로네이트 나트륨 다형태
US20090042839A1 (en) * 2007-08-09 2009-02-12 Sharon Avhar-Maydan Crystalline forms of ibandronate sodium
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
EP2180003A1 (en) 2008-10-21 2010-04-28 Zentiva, k.s. Preparation of ibandronate trisodium
WO2011016738A1 (en) 2009-08-05 2011-02-10 Zaklady Farmaceutyczne Polpharma Sa A process for the synthesis of 1-hydroxy-3-(n-methylpentylamino) propylidene bisphosphonic acid monosodium salt, monohydrate
WO2012007021A1 (en) 2010-07-14 2012-01-19 Pharmathen S.A. Process for the preparation of 3-(n-methyl-n-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid salt or derivatives thereof
TR201200588A2 (tr) 2012-01-18 2012-07-23 Koçak Farma İlaç Ve Ki̇mya Sanayi̇ Anoni̇m Şi̇rketi̇ Sodyum ibandronat monohidrat polimorflarini ve polimorflu karışımlarını hazırlamak için prosesler.
KR20200085441A (ko) 2019-01-07 2020-07-15 엠에프씨 주식회사 이반드로네이트의 신규한 결정형 및 이의 제조방법

Family Cites Families (18)

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US3764604A (en) * 1968-12-17 1973-10-09 Us Army 4-pyridylcarbinolamine anti-malarials
DE3623397A1 (de) * 1986-07-11 1988-01-14 Boehringer Mannheim Gmbh Neue diphosphonsaeurederivate, verfahren zu deren herstellung und diese verbindungen enthaltende arzneimittel
TW198039B (es) * 1988-11-28 1993-01-11 Ciba Geigy Ag
MC2311A1 (fr) * 1990-07-10 1993-09-27 Smithkline Beecham Corp Oxamides
DE19531264A1 (de) * 1995-08-25 1997-02-27 Hoechst Ag Kationische, ungesättigte Saccharide sowie daraus hergestellte Polymerisate und deren Verwendung
RU2172742C2 (ru) * 1995-12-28 2001-08-27 Пфайзер Инк. Стимуляторы секреции гормона роста
IT1303672B1 (it) * 1998-07-28 2001-02-23 Nicox Sa Sali nitrati di farmaci attivi nei disordini ossei
EP0998932A1 (de) 1998-10-09 2000-05-10 Boehringer Mannheim Gmbh Feste pharmazeutische Darreichungsform enthaltend Diphosphonsäure oder deren Salze und Verfahren zu ihrer Herstellung
SK284569B6 (sk) 1998-10-16 2005-06-02 Akzo Nobel N.V. Vysoko čistá zlúčenina (7alfa, 17alfa)-17-hydroxy-7-metyl-19-nor- 17-pregn-5(10)-én-20-ín-3-ón, spôsob jej prípravy a farmaceutická dávková jednotka s jej obsahom
AU756540B2 (en) * 1998-12-04 2003-01-16 Roche Diagnostics Gmbh Use of ibandronate for promoting osseointegration of endoprostheses
US6677320B2 (en) * 2000-01-20 2004-01-13 Hoffmann-La Roches Inc. Parenteral bisphosphonate composition with improved local tolerance
WO2001075080A1 (en) * 2000-03-30 2001-10-11 Research Development Foundation Tyr393 and tyr398 mutants of monoamine oxidase b
CN1404836A (zh) * 2001-09-14 2003-03-26 中生北方生物工程开发研究所 埃本膦酸钠作为预防和治疗骨质疏松症的药物的有效成分的应用
KR20140021045A (ko) * 2002-05-10 2014-02-19 에프. 호프만-라 로슈 아게 골다공증 치료 및 예방용 비스포스폰산
WO2006002348A2 (en) * 2004-06-23 2006-01-05 Teva Pharmaceutical Industies Ltd. Solid and crystalline ibandronic acid
DE602005025977D1 (de) * 2004-08-23 2011-03-03 Teva Pharma Kristalline form des ibandronat-natriums und herstellungsverfahren dafür
KR100908529B1 (ko) 2005-02-01 2009-07-20 에프. 호프만-라 로슈 아게 이반드로네이트 다형체 에이
JP5828607B2 (ja) * 2005-02-01 2015-12-09 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ イバンドロネート多形ｂ

Also Published As

Publication number Publication date
EP1848727A1 (en) 2007-10-31
IL184720A0 (en) 2007-12-03
IL184720A (en) 2014-12-31
ZA200706170B (en) 2008-09-25
EP1848727B1 (en) 2015-06-17
US20060172976A1 (en) 2006-08-03
MX2007008917A (es) 2007-08-21
EP2363401A1 (en) 2011-09-07
JP5828607B2 (ja) 2015-12-09
WO2006081962A1 (en) 2006-08-10
AU2006210008B2 (en) 2009-10-08
RU2387661C2 (ru) 2010-04-27
JP2015205908A (ja) 2015-11-19
US7582789B2 (en) 2009-09-01
TW200640940A (en) 2006-12-01
EP2610261A1 (en) 2013-07-03
PL1848727T3 (pl) 2015-11-30
AR053119A1 (es) 2007-04-25
CN101111505A (zh) 2008-01-23
JP6039755B2 (ja) 2016-12-07
KR100908530B1 (ko) 2009-07-20
US20090312289A1 (en) 2009-12-17
CN101111505B (zh) 2011-09-14
CA2594717C (en) 2015-01-20
DK1848727T3 (da) 2015-07-20
NO20073755L (no) 2007-08-28
JP2008531480A (ja) 2008-08-14
TWI374888B (en) 2012-10-21
CA2594717A1 (en) 2006-08-10
KR20070100395A (ko) 2007-10-10
SI1848727T1 (sl) 2015-09-30
BRPI0607093A2 (pt) 2009-08-04
AU2006210008A1 (en) 2006-08-10
RU2007132700A (ru) 2009-03-10

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