WO2005080381A1 - Nouvelles formes polymorphes d'ondansetron et leurs procedes de preparation, et compositions pharmaceutiques contenant lesdites nouvelles formes polymorphes et leur utilisation comme antivomitif - Google Patents

Nouvelles formes polymorphes d'ondansetron et leurs procedes de preparation, et compositions pharmaceutiques contenant lesdites nouvelles formes polymorphes et leur utilisation comme antivomitif Download PDF

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Publication number
WO2005080381A1
WO2005080381A1 PCT/IB2005/000141 IB2005000141W WO2005080381A1 WO 2005080381 A1 WO2005080381 A1 WO 2005080381A1 IB 2005000141 W IB2005000141 W IB 2005000141W WO 2005080381 A1 WO2005080381 A1 WO 2005080381A1
Authority
WO
WIPO (PCT)
Prior art keywords
ondansetron
polymorphic form
powder
ray diffraction
diffraction pattern
Prior art date
Application number
PCT/IB2005/000141
Other languages
English (en)
Inventor
Pere Dalmases Barjoan
Lluís Solà Carandell
Francesc Alcobe Olle
Maria Cristina Puigjaner Vallet
Original Assignee
Inke, S.A.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34802828&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2005080381(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Inke, S.A. filed Critical Inke, S.A.
Priority to JP2006550337A priority Critical patent/JP2007518791A/ja
Priority to EP05702302A priority patent/EP1709033A1/fr
Publication of WO2005080381A1 publication Critical patent/WO2005080381A1/fr

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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
    • A61K31/33—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
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D403/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/06—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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

Definitions

  • the subject-matter of the present invention is to provide three different polymorphic forms of ( ⁇ ) 1,2, 3,9- tetrahydro-9-methyl-3- [ (2-methyl-lH-imidazol-l-il) methyl] - 4H-carbazol-4-one, known under the INN of ondansetron.
  • Figure 1 shows the powder X-ray diffraction pattern of the Form C.
  • the y-axis represents the intensity (in counts) and the x-axis represents the angle 2 Theta.
  • Figure 2 shows the powder X-ray diffraction pattern of the Form D.
  • Figure 3 shows the powder X-ray diffraction pattern of the Form E.
  • Figure 4 shows the low-frequency Raman spectrum of Forms C, D and E.
  • the y-axis shows the Raman intensity (in A.U., arbitrary units) and the x-axis the frequency.
  • said Cs-C 7 alkane is chosen from n-hexane or n-pentane.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne de nouveaux polymorphes de (±)1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-il)methyl]-4H-carbazol-4-one, connus sous le nom d'INN d'ondansetron, des procédés permettant de préparer ces polymorphes, des compositions pharmaceutiques contenant lesdits polymorphes et leur utilisation dans le traitement et la prophylaxie de la nausée et des vomissements. Cette invention permet d'obtenir de nouvelles formes polymorphes stables d'ondansetron et met en oeuvre leurs procédés de production à une échelle industrielle.
PCT/IB2005/000141 2004-01-21 2005-01-20 Nouvelles formes polymorphes d'ondansetron et leurs procedes de preparation, et compositions pharmaceutiques contenant lesdites nouvelles formes polymorphes et leur utilisation comme antivomitif WO2005080381A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2006550337A JP2007518791A (ja) 2004-01-21 2005-01-20 オンダンセトロンの新規多形体、該多形体の製造方法、該多形体を含有する医薬組成物、および抗嘔吐剤としての該多形体の使用
EP05702302A EP1709033A1 (fr) 2004-01-21 2005-01-20 Nouvelles formes polymorphes d'ondansetron et leurs procedes de preparation, et compositions pharmaceutiques contenant lesdites nouvelles formes polymorphes et leur utilisation comme antivomitif

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200400115A ES2238001B1 (es) 2004-01-21 2004-01-21 Nuevas formas polimorficas de ondansetron, procedimientos para su preparacion, composiciones farmaceuticas que los contienen y su uso como aantiemeticos.
ESP-200400115 2004-01-21

Publications (1)

Publication Number Publication Date
WO2005080381A1 true WO2005080381A1 (fr) 2005-09-01

Family

ID=34802828

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2005/000141 WO2005080381A1 (fr) 2004-01-21 2005-01-20 Nouvelles formes polymorphes d'ondansetron et leurs procedes de preparation, et compositions pharmaceutiques contenant lesdites nouvelles formes polymorphes et leur utilisation comme antivomitif

Country Status (8)

Country Link
EP (1) EP1709033A1 (fr)
JP (1) JP2007518791A (fr)
KR (1) KR20060127892A (fr)
AR (1) AR047435A1 (fr)
ES (1) ES2238001B1 (fr)
PE (1) PE20050766A1 (fr)
TW (1) TW200528100A (fr)
WO (1) WO2005080381A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2248519A2 (fr) 2006-10-02 2010-11-10 Labtec GmbH Formes galéniques de film non mucoadhésifs
WO2011117313A1 (fr) 2010-03-23 2011-09-29 Bioalliance Pharma Systèmes d'administration de médicaments à dissolution rapide
EP2377526A1 (fr) 2010-03-23 2011-10-19 BioAlliance Pharma Systèmes d'administration de médicaments à dissolution rapide
US10076513B2 (en) 2010-04-07 2018-09-18 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
US10231932B2 (en) 2013-11-12 2019-03-19 Vertex Pharmaceuticals Incorporated Process of preparing pharmaceutical compositions for the treatment of CFTR mediated diseases
US10597384B2 (en) 2007-12-07 2020-03-24 Vertex Pharmaceuticals Incorporated Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
US10626111B2 (en) 2004-01-30 2020-04-21 Vertex Pharmaceuticals Incorporated Modulators of ATP-binding cassette transporters

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2153821A (en) * 1984-01-25 1985-08-29 Glaxo Group Ltd 3-Imidazolylmethyl-1,2,3,9-tetrahydro-4H-carbazol-4-one derivatives
DE20312772U1 (de) * 2003-08-19 2003-10-30 Synthon Bv Ondansetron-Formen
WO2003093260A1 (fr) * 2002-04-30 2003-11-13 Biogal Gyogyszergyar Rt. Nouvelles formes cristallines d'ondansetron, procedes de preparation correspondant, compositions pharmaceutiques contenant ces nouvelles formes et procedes de traitement de la nausee au moyen des ces nouvelles formes

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2199061B1 (es) 2002-06-10 2005-02-16 Laboratorios Vita, S.A. Comprimidos bucodispersables y procedimiento para su obtencion.
FI6164U1 (fi) 2003-01-09 2004-03-15 Synthon Bv Ondansetronmuotoja

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2153821A (en) * 1984-01-25 1985-08-29 Glaxo Group Ltd 3-Imidazolylmethyl-1,2,3,9-tetrahydro-4H-carbazol-4-one derivatives
WO2003093260A1 (fr) * 2002-04-30 2003-11-13 Biogal Gyogyszergyar Rt. Nouvelles formes cristallines d'ondansetron, procedes de preparation correspondant, compositions pharmaceutiques contenant ces nouvelles formes et procedes de traitement de la nausee au moyen des ces nouvelles formes
DE20312772U1 (de) * 2003-08-19 2003-10-30 Synthon Bv Ondansetron-Formen

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1709033A1 *

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10626111B2 (en) 2004-01-30 2020-04-21 Vertex Pharmaceuticals Incorporated Modulators of ATP-binding cassette transporters
US11084804B2 (en) 2005-11-08 2021-08-10 Vertex Pharmaceuticals Incorporated Modulators of ATP-binding cassette transporters
US9682037B2 (en) 2006-10-02 2017-06-20 Apr Applied Pharma Research Sa Non-mucoadhesive film dosage forms
EP2444072A2 (fr) 2006-10-02 2012-04-25 Labtec GmbH Formes galéniques de film non mucoadhésifs
DE202007019476U1 (de) 2006-10-02 2013-01-25 Labtec Gmbh Nicht-mucoadhäsive Filmdosisformen
US8580830B2 (en) 2006-10-02 2013-11-12 Labtec Gmbh Non-mucoadhesive film dosage forms
EP2248519A2 (fr) 2006-10-02 2010-11-10 Labtec GmbH Formes galéniques de film non mucoadhésifs
US10597384B2 (en) 2007-12-07 2020-03-24 Vertex Pharmaceuticals Incorporated Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
US12065432B2 (en) 2007-12-07 2024-08-20 Vertex Pharmaceuticals Incorporated Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
EP2377526A1 (fr) 2010-03-23 2011-10-19 BioAlliance Pharma Systèmes d'administration de médicaments à dissolution rapide
WO2011117313A1 (fr) 2010-03-23 2011-09-29 Bioalliance Pharma Systèmes d'administration de médicaments à dissolution rapide
US10076513B2 (en) 2010-04-07 2018-09-18 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
US11052075B2 (en) 2010-04-07 2021-07-06 Vertex Pharmaceuticals Incorporated Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
US10231932B2 (en) 2013-11-12 2019-03-19 Vertex Pharmaceuticals Incorporated Process of preparing pharmaceutical compositions for the treatment of CFTR mediated diseases

Also Published As

Publication number Publication date
ES2238001B1 (es) 2006-11-01
TW200528100A (en) 2005-09-01
ES2238001A1 (es) 2005-08-01
AR047435A1 (es) 2006-01-18
KR20060127892A (ko) 2006-12-13
PE20050766A1 (es) 2005-12-14
EP1709033A1 (fr) 2006-10-11
JP2007518791A (ja) 2007-07-12

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