WO2002055492A3 - An improved process for preparing pure ondansetron hydrochloride dihydrate - Google Patents

An improved process for preparing pure ondansetron hydrochloride dihydrate Download PDF

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Publication number
WO2002055492A3
WO2002055492A3 PCT/US2002/000853 US0200853W WO02055492A3 WO 2002055492 A3 WO2002055492 A3 WO 2002055492A3 US 0200853 W US0200853 W US 0200853W WO 02055492 A3 WO02055492 A3 WO 02055492A3
Authority
WO
WIPO (PCT)
Prior art keywords
hydrochloride dihydrate
improved process
ondansetron hydrochloride
preparing pure
pure ondansetron
Prior art date
Application number
PCT/US2002/000853
Other languages
French (fr)
Other versions
WO2002055492A2 (en
Inventor
Ramy Lidor Hadas
Eliezer Bachar
Original Assignee
Teva Pharma
Ramy Lidor Hadas
Eliezer Bachar
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
Priority to AU2002236753A priority Critical patent/AU2002236753B2/en
Priority to KR10-2003-7009221A priority patent/KR20030068583A/en
Priority to JP2002556165A priority patent/JP2004526692A/en
Priority to MXPA03006215A priority patent/MXPA03006215A/en
Application filed by Teva Pharma, Ramy Lidor Hadas, Eliezer Bachar filed Critical Teva Pharma
Priority to EP02703115A priority patent/EP1355881A4/en
Priority to DE02703115T priority patent/DE02703115T1/en
Priority to HU0400767A priority patent/HUP0400767A2/en
Priority to SK989-2003A priority patent/SK9892003A3/en
Priority to CA002433720A priority patent/CA2433720A1/en
Priority to IL15683502A priority patent/IL156835A0/en
Publication of WO2002055492A2 publication Critical patent/WO2002055492A2/en
Publication of WO2002055492A3 publication Critical patent/WO2002055492A3/en
Priority to IS6869A priority patent/IS6869A/en
Priority to NO20033147A priority patent/NO20033147L/en
Priority to HR20030631A priority patent/HRP20030631A2/en

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    • 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
    • C07D209/56—Ring systems containing three or more rings
    • C07D209/80—[b, c]- or [b, d]-condensed
    • C07D209/82—Carbazoles; Hydrogenated carbazoles
    • C07D209/86—Carbazoles; Hydrogenated carbazoles with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to carbon atoms of the ring system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D231/00—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings
    • C07D231/02—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings
    • C07D231/10—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
    • C07D231/12—Heterocyclic compounds containing 1,2-diazole or hydrogenated 1,2-diazole rings not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • 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
    • C07D209/56—Ring systems containing three or more rings
    • C07D209/80—[b, c]- or [b, d]-condensed
    • C07D209/82—Carbazoles; Hydrogenated carbazoles
    • C07D209/88—Carbazoles; Hydrogenated carbazoles with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to carbon atoms of the ring system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D233/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
    • C07D233/54—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members
    • C07D233/56—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members with only hydrogen atoms or radicals containing only hydrogen and carbon atoms, attached to ring carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D249/00—Heterocyclic compounds containing five-membered rings having three nitrogen atoms as the only ring hetero atoms
    • C07D249/02—Heterocyclic compounds containing five-membered rings having three nitrogen atoms as the only ring hetero atoms not condensed with other rings
    • C07D249/08—1,2,4-Triazoles; Hydrogenated 1,2,4-triazoles

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
  • Otolaryngology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Indole Compounds (AREA)

Abstract

An improved method for preparing dimethylamino-methyl-carbazolone and ondansetron base. A recrystallization process for preparing pure ondansetron hydrochloride dihydrate with a purity of at least 99.0% is also disclosed.
PCT/US2002/000853 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate WO2002055492A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
DE02703115T DE02703115T1 (en) 2001-01-11 2002-01-11 IMPROVED METHOD FOR PRODUCING PURE ONDANSETRONHYDROCHLORIDE DIHYDRATE
JP2002556165A JP2004526692A (en) 2001-01-11 2002-01-11 An improved method for producing pure ondansetron hydrochloride dihydrate
MXPA03006215A MXPA03006215A (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate.
SK989-2003A SK9892003A3 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
EP02703115A EP1355881A4 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
KR10-2003-7009221A KR20030068583A (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
HU0400767A HUP0400767A2 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
AU2002236753A AU2002236753B2 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
CA002433720A CA2433720A1 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
IL15683502A IL156835A0 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate
IS6869A IS6869A (en) 2001-01-11 2003-07-08 Improved method of producing pure ondansetron hydrochloride dihydrate
NO20033147A NO20033147L (en) 2001-01-11 2003-07-09 Process for the preparation of pure ondansetron hydrochloride dihydrate
HR20030631A HRP20030631A2 (en) 2001-01-11 2003-08-06 An improved process for preparing pure ondansetron hydrocloride dihydrate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26105201P 2001-01-11 2001-01-11
US60/261,052 2001-01-11

Publications (2)

Publication Number Publication Date
WO2002055492A2 WO2002055492A2 (en) 2002-07-18
WO2002055492A3 true WO2002055492A3 (en) 2003-02-13

Family

ID=22991757

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/000853 WO2002055492A2 (en) 2001-01-11 2002-01-11 An improved process for preparing pure ondansetron hydrochloride dihydrate

Country Status (21)

Country Link
EP (1) EP1355881A4 (en)
JP (1) JP2004526692A (en)
KR (3) KR20070054749A (en)
CN (2) CN1496350A (en)
AU (1) AU2002236753B2 (en)
CA (1) CA2433720A1 (en)
CZ (1) CZ20032090A3 (en)
DE (1) DE02703115T1 (en)
ES (1) ES2219201T1 (en)
HR (1) HRP20030631A2 (en)
HU (1) HUP0400767A2 (en)
IL (1) IL156835A0 (en)
IS (1) IS6869A (en)
MX (1) MXPA03006215A (en)
NO (1) NO20033147L (en)
PL (1) PL368837A1 (en)
SK (1) SK9892003A3 (en)
TR (1) TR200401460T3 (en)
WO (1) WO2002055492A2 (en)
YU (1) YU56103A (en)
ZA (1) ZA200305338B (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7098345B2 (en) 2002-04-29 2006-08-29 TEVA Gyógyszergyár Zárkörüen Müködö Részvénytársaság Process for preparing 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-YL)methyl]-4H-carbazol-4-one
HU225885B1 (en) * 2002-10-17 2007-11-28 Richter Gedeon Nyrt Process for producing ondansetron hydrochlorid dihydrate of high purity
FI6164U1 (en) * 2003-01-09 2004-03-15 Synthon Bv Ondansetronformer
GB2398071B (en) * 2003-01-24 2006-06-07 Synthon Bv Process for making ondansetron and intermediate thereof
US7696356B2 (en) 2004-08-17 2010-04-13 Taro Pharmaceutical Industries Limited Process for preparing 1,2,3,9-tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one and ondansetron therefrom
EP1828141A4 (en) * 2004-10-26 2009-04-01 Ipca Lab Ltd A one-pot process for the preparation of antiemetic agent, 1,2,3,9-tetrahydro-9-methyl-3[(2-methyl)-1h-imidazole-1-yl)methyl]-4h-carbazol-4-o

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4695578A (en) * 1984-01-25 1987-09-22 Glaxo Group Limited 1,2,3,9-tetrahydro-3-imidazol-1-ylmethyl-4H-carbazol-4-ones, composition containing them, and method of using them to treat neuronal 5HT function disturbances
US4835173A (en) * 1986-12-17 1989-05-30 Glaxo Group Limited Method of medical treatment

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2002230935A1 (en) * 2000-10-30 2002-05-15 Teva Pharmaceutical Industries Ltd. Novel crystal and solvate forms of ondansetron hydrochloride and processes for their preparation

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4695578A (en) * 1984-01-25 1987-09-22 Glaxo Group Limited 1,2,3,9-tetrahydro-3-imidazol-1-ylmethyl-4H-carbazol-4-ones, composition containing them, and method of using them to treat neuronal 5HT function disturbances
US4835173A (en) * 1986-12-17 1989-05-30 Glaxo Group Limited Method of medical treatment

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHEMICAL ABSTRACTS, vol. 120, no. 13, 28 March 1994, Columbus, Ohio, US; abstract no. 164116Q, CHEN: "Synthesis of antiemetic ondansetron" page 1178; column 1; XP002953487 *
ZHONGGUO YIYAO GONGYE ZAZHI, vol. 24, no. 6, 1993, pages 241 - 242 *

Also Published As

Publication number Publication date
IS6869A (en) 2003-07-08
MXPA03006215A (en) 2005-02-17
JP2004526692A (en) 2004-09-02
PL368837A1 (en) 2005-04-04
CA2433720A1 (en) 2002-07-18
HUP0400767A2 (en) 2004-07-28
EP1355881A4 (en) 2004-03-31
YU56103A (en) 2006-05-25
KR20070054749A (en) 2007-05-29
ZA200305338B (en) 2004-07-12
WO2002055492A2 (en) 2002-07-18
EP1355881A2 (en) 2003-10-29
ES2219201T1 (en) 2004-12-01
CZ20032090A3 (en) 2004-08-18
SK9892003A3 (en) 2004-05-04
HRP20030631A2 (en) 2005-06-30
DE02703115T1 (en) 2004-10-21
KR20060113792A (en) 2006-11-02
NO20033147D0 (en) 2003-07-09
TR200401460T3 (en) 2004-08-23
CN101045704A (en) 2007-10-03
KR20030068583A (en) 2003-08-21
IL156835A0 (en) 2004-02-08
NO20033147L (en) 2003-09-02
CN1496350A (en) 2004-05-12
AU2002236753B2 (en) 2007-06-28

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