WO2007075838A3 - Pure and stable tiotropium bromide - Google Patents

Pure and stable tiotropium bromide Download PDF

Info

Publication number
WO2007075838A3
WO2007075838A3 PCT/US2006/048690 US2006048690W WO2007075838A3 WO 2007075838 A3 WO2007075838 A3 WO 2007075838A3 US 2006048690 W US2006048690 W US 2006048690W WO 2007075838 A3 WO2007075838 A3 WO 2007075838A3
Authority
WO
WIPO (PCT)
Prior art keywords
tiotropium bromide
pure
solvates
stable tiotropium
stable
Prior art date
Application number
PCT/US2006/048690
Other languages
French (fr)
Other versions
WO2007075838A2 (en
Inventor
Roberta Volonte
Nicola Diulgheroff
Francesca Scarpitta
Alessandro Pontiroli
Roberto Casalone
Original Assignee
Sicor Inc
Roberta Volonte
Nicola Diulgheroff
Francesca Scarpitta
Alessandro Pontiroli
Roberto Casalone
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 Sicor Inc, Roberta Volonte, Nicola Diulgheroff, Francesca Scarpitta, Alessandro Pontiroli, Roberto Casalone filed Critical Sicor Inc
Priority to EP06845924A priority Critical patent/EP1966196A2/en
Priority to MX2007009987A priority patent/MX2007009987A/en
Priority to BRPI0608423-0A priority patent/BRPI0608423A2/en
Priority to JP2007556440A priority patent/JP2008530251A/en
Priority to CNA2006800476882A priority patent/CN101360744A/en
Priority to CA002620142A priority patent/CA2620142A1/en
Publication of WO2007075838A2 publication Critical patent/WO2007075838A2/en
Publication of WO2007075838A3 publication Critical patent/WO2007075838A3/en
Priority to IL188178A priority patent/IL188178A0/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D451/00—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof
    • C07D451/02—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof
    • C07D451/04—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof with hetero atoms directly attached in position 3 of the 8-azabicyclo [3.2.1] octane or in position 7 of the 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring system
    • C07D451/06—Oxygen atoms
    • C07D451/10—Oxygen atoms acylated by aliphatic or araliphatic carboxylic acids, e.g. atropine, scopolamine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • 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
    • A61P11/06—Antiasthmatics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pulmonology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

This invention relates to solvates of tiotropium bromide having a purity of at least 99%, process for preparing such pure solvates, and their use in pharmaceutical, formulations. This invention also provides tiotropium bromide solvates containing less than about 0.15% area by HPLC of 2,2-dithienyl glycolic acid.
PCT/US2006/048690 2005-12-19 2006-12-19 Pure and stable tiotropium bromide WO2007075838A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP06845924A EP1966196A2 (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide
MX2007009987A MX2007009987A (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide.
BRPI0608423-0A BRPI0608423A2 (en) 2005-12-19 2006-12-19 pure and stable tiotropium bromide
JP2007556440A JP2008530251A (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide
CNA2006800476882A CN101360744A (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide
CA002620142A CA2620142A1 (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide
IL188178A IL188178A0 (en) 2005-12-19 2007-12-17 Pure and stable tiotropium bromide

Applications Claiming Priority (24)

Application Number Priority Date Filing Date Title
US75267205P 2005-12-19 2005-12-19
US60/752,672 2005-12-19
US75453005P 2005-12-27 2005-12-27
US60/754,530 2005-12-27
US76143706P 2006-01-23 2006-01-23
US60/761,437 2006-01-23
US77405106P 2006-02-15 2006-02-15
US60/774,051 2006-02-15
US78031006P 2006-03-07 2006-03-07
US60/780,310 2006-03-07
US83023106P 2006-07-10 2006-07-10
US60/830,231 2006-07-10
US83218906P 2006-07-20 2006-07-20
US60/832,189 2006-07-20
US83520106P 2006-08-03 2006-08-03
US83520006P 2006-08-03 2006-08-03
US60/835,201 2006-08-03
US60/835,200 2006-08-03
US83603706P 2006-08-07 2006-08-07
US60/836,037 2006-08-07
US85122306P 2006-10-12 2006-10-12
US60/851,223 2006-10-12
US85274006P 2006-10-18 2006-10-18
US60/852,740 2006-10-18

Publications (2)

Publication Number Publication Date
WO2007075838A2 WO2007075838A2 (en) 2007-07-05
WO2007075838A3 true WO2007075838A3 (en) 2007-08-16

Family

ID=38105786

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/048690 WO2007075838A2 (en) 2005-12-19 2006-12-19 Pure and stable tiotropium bromide

Country Status (9)

Country Link
EP (1) EP1966196A2 (en)
JP (1) JP2008530251A (en)
KR (1) KR20080079586A (en)
CN (1) CN101360744A (en)
CA (1) CA2620142A1 (en)
IL (1) IL188178A0 (en)
MX (1) MX2007009987A (en)
TW (1) TW200734333A (en)
WO (1) WO2007075838A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102639531B (en) * 2009-08-07 2016-01-20 基因里克斯(英国)有限公司 The anhydrate of tiotropium bromide
WO2011015883A1 (en) * 2009-08-07 2011-02-10 Generics [Uk] Limited Dichloromethane solvate of tiotropium bromide and its use
WO2011095800A2 (en) * 2010-02-02 2011-08-11 Generics [Uk] Limited Analytical methods
CN101863885B (en) * 2010-06-03 2012-05-30 南京金丹呈医药技术有限公司 Method for preparing tiotropium bromide
TR201101897A2 (en) * 2011-02-28 2012-09-21 Bi̇lgi̇ç Mahmut Crystal material containing tiotropium bromide
CZ304368B6 (en) * 2011-11-28 2014-04-02 Zentiva, K.S. Tiotropium bromide mixed solvate and process for preparing thereof
CN103130798B (en) * 2011-11-30 2015-12-02 连云港润众制药有限公司 The crystallization of tiotropium bromide
PT106142B (en) * 2012-02-10 2014-07-18 Hovione Farmaci Ncia S A PROCESS FOR THE PREPARATION OF TIOTROPE BROMIDE
EP2789611A1 (en) * 2013-04-08 2014-10-15 Cerbios-Pharma S.A. A crystalline form of tiotropium bromide

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002030928A1 (en) * 2000-10-12 2002-04-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament
WO2002051840A1 (en) * 2000-12-22 2002-07-04 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for producing the anticholinergic agent tiotropium bromide
US20020110529A1 (en) * 2000-10-12 2002-08-15 Karoline Bechtold-Peters Inhalable powder containing tiotropium
US20050096341A1 (en) * 2003-11-03 2005-05-05 Boehringer Ingelheim International Gmbh Novel tiotropium salts, process for the preparation and pharmaceutical compositions thereof
WO2006117299A2 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Novel crystalline forms of tiotropium bromide
WO2006117300A2 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Crystalline forms of tiotropium bromide

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002030928A1 (en) * 2000-10-12 2002-04-18 Boehringer Ingelheim Pharma Gmbh & Co. Kg Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament
US20020110529A1 (en) * 2000-10-12 2002-08-15 Karoline Bechtold-Peters Inhalable powder containing tiotropium
WO2002051840A1 (en) * 2000-12-22 2002-07-04 Boehringer Ingelheim Pharma Gmbh & Co. Kg Method for producing the anticholinergic agent tiotropium bromide
US20050096341A1 (en) * 2003-11-03 2005-05-05 Boehringer Ingelheim International Gmbh Novel tiotropium salts, process for the preparation and pharmaceutical compositions thereof
WO2006117299A2 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Novel crystalline forms of tiotropium bromide
WO2006117300A2 (en) * 2005-05-02 2006-11-09 Boehringer Ingelheim International Gmbh Crystalline forms of tiotropium bromide

Also Published As

Publication number Publication date
KR20080079586A (en) 2008-09-01
EP1966196A2 (en) 2008-09-10
CA2620142A1 (en) 2007-07-05
JP2008530251A (en) 2008-08-07
IL188178A0 (en) 2008-03-20
MX2007009987A (en) 2007-10-02
WO2007075838A2 (en) 2007-07-05
CN101360744A (en) 2009-02-04
TW200734333A (en) 2007-09-16

Similar Documents

Publication Publication Date Title
PL2018379T3 (en) Scopine salts and their use in processes for the preparation of n-demethyl-tiotropium and tiotropium bromide
WO2007075838A3 (en) Pure and stable tiotropium bromide
HK1210047A1 (en) 3,7-diamino-10h-phenothiazine salts and their use 37--10h-
MY142029A (en) Phenoxyacetic acid derivatives
WO2005082892A3 (en) Triazole compounds as antibacterial agents and pharmaceutical compositions containing them
UA90130C2 (en) Amorphous lercanidipine hydrochloride and pharmaceutical composition based thereon
WO2006114520A3 (en) Substituted pyrrolo-pyridines, composition containing them, method for their producing and use thereof
TW200639156A (en) New compounds
EP2269608A3 (en) Pharmaceutical composition comprising a monoamine neurotransmitter re-uptake inhibitor and an acetylcholinesterase inhibitor
WO2004078105A3 (en) Fondaparinux sodium composition of high purity, method for production of said composition and pharmaceutical compositions containing the same as active ingredient
EP1831239B8 (en) A process for the preparation of 17-hydroxy-6 beta, 7 beta, 15 beta, 16 beta -bismethylene-17 alpha-pregn-4-ene-3-one-21-carboxylic acid gamma-lactone and key-intermediates for this process
MY135218A (en) 2,6-quinolinyl and 2,6-naphthyl derivatives and their use in the treatment of vla-4 dependent diseases
TW200637861A (en) Novel diazabicyclononene derivative
WO2006134021A3 (en) Process for preparing tiotropium salts, tiotropium salts as such and pharmaceutical compositions thereof
TW200800984A (en) New compounds
CA2412047A1 (en) Shortened synthesis of 3,3-diarylpropylamine derivatives
MXPA02012889A (en) 4-alkoxy cyclohexane-1 amino carboxylic acid esters and method for the production thereof.
MXPA05011496A (en) Azabicyclononene derivatives.
WO2004106307A3 (en) Novel imidazole derivatives, the production thereof, and the use of the same as a medicament
WO2008110337A3 (en) Pharmaceutical composition of quetiapine fumarate
WO2004069145A3 (en) Anticancer compounds, process for their preparation and pharmaceutical compositions containing them
TW200634014A (en) Novel diazabicyclononene derivative
WO2007005763A3 (en) Combination of a renin inhibitor and an insulin secretion enhancer or an insulin sensitizer
MX2009005804A (en) Pharmaceutical composition of memantine.
WO2007044574A3 (en) Pharmaceutical compositions, methods of preparation thereof, and methods of treatment

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 200680047688.2

Country of ref document: CN

WWE Wipo information: entry into national phase

Ref document number: 2006845924

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2007556440

Country of ref document: JP

Ref document number: MX/a/2007/009987

Country of ref document: MX

Ref document number: 1020077018779

Country of ref document: KR

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 188178

Country of ref document: IL

ENP Entry into the national phase

Ref document number: 2620142

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 1764/DELNP/2008

Country of ref document: IN

WWE Wipo information: entry into national phase

Ref document number: 2008124910

Country of ref document: RU

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: PI0608423

Country of ref document: BR

Kind code of ref document: A2