IL159238A - Crystalline anticholinergic, method for its production and use thereof in the production of a drug - Google Patents
Crystalline anticholinergic, method for its production and use thereof in the production of a drugInfo
- Publication number
- IL159238A IL159238A IL159238A IL15923803A IL159238A IL 159238 A IL159238 A IL 159238A IL 159238 A IL159238 A IL 159238A IL 15923803 A IL15923803 A IL 15923803A IL 159238 A IL159238 A IL 159238A
- Authority
- IL
- Israel
- Prior art keywords
- tiotropium bromide
- crystalline
- anhydrous
- production
- pharmaceutical composition
- Prior art date
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
Abstract
The invention relates to crystalline, water-free (1 alpha ,2 beta ,4 beta ,5 alpha ,7 beta )-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0<2,4>]nonane-bromide, to a method for its production, and to the use thereof in the production of a drug, especially in the production of an anticholinergic drug.
[WO03000265A1]
Claims (10)
1. 59238/2 19 78190amd.209^r Amended claims V 1 ) Anhydrous crystalline tiotropium bromide, characterised by a monoclinic elementary cell with the parameters a = 10.4336(2)A, b = 11 .3297(3)A, c = 17.6332(4) A, a = 90°, β = 105.158(2)° and λ = 90° (cell volume=201 1.89(8) A3) determined by X-ray structural analysis.
2. ) Process for preparing crystalline, anhydrous tiotropium bromide according to claim 1, characterized in that it is prepared by careful drying of monohydrate tiotropium bromide at more than 50°C, preferably at 60-100°C, under reduced pressure.
3. ) Process according to claim 2, characterised in that the drying is carried out over a period of from 15 minutes to 24 hours.
4. ) Process for preparing crystalline, anhydrous tiotropium bromide, according to claim 1 , characterised in that it is prepared by storing crystalline tiotropium bromide monohydrate over a suitable drying agent for a period of 12 to 96 hours.
5. ) Crystalline anhydrous tiotropium bromide, obtainable according to one of claims 2, 3 or 4.
6. ) Pharmaceutical composition, characterised in that it contains crystalline anhydrous tiotropium bromide according to one of claims 1 or 5.
7. ) Pharmaceutical composition according to claim 6, characterised in that it is an inhalable powder.
8. ) Inhalable powder according to claim 7, characterised in that it contains crystalline anhydrous tiotropium bromide according to claim 1 or 5 in admixture with a physiologically acceptable excipient.
9. ) Inhalable powder according to claim 8, characterised in that the excipient is selected from the group consisting of glucose and lactose.
10. ) Use of crystalline anhydrous tiotropium bromide according to one of claims 1 or 5 for preparing a pharmaceutical composition for the treatment of diseases in which the administration of an anticholinergic may have a therapeutic benefit. 1 Use according to claim 10, characterised in that the diseases are asthma or COPD. For th© Applicants MOID COHM AND PABINBS
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10129710 | 2001-06-22 | ||
DE10215436 | 2002-04-08 | ||
PCT/EP2002/006291 WO2003000265A1 (en) | 2001-06-22 | 2002-06-08 | Crystalline anticholinergic, method for its production, and use thereof in the production of a drug |
Publications (1)
Publication Number | Publication Date |
---|---|
IL159238A true IL159238A (en) | 2010-04-15 |
Family
ID=26009556
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
IL15923802A IL159238A0 (en) | 2001-06-22 | 2002-06-08 | Crystalline anticholinergic, method for its production, and use thereof in the production of a drug |
IL159238A IL159238A (en) | 2001-06-22 | 2003-12-08 | Crystalline anticholinergic, method for its production and use thereof in the production of a drug |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
IL15923802A IL159238A0 (en) | 2001-06-22 | 2002-06-08 | Crystalline anticholinergic, method for its production, and use thereof in the production of a drug |
Country Status (38)
Country | Link |
---|---|
EP (1) | EP1401445B1 (en) |
JP (1) | JP2005504015A (en) |
KR (2) | KR100971616B1 (en) |
CN (1) | CN100586948C (en) |
AR (1) | AR037491A1 (en) |
AT (1) | ATE337006T1 (en) |
AU (1) | AU2002345016B2 (en) |
BG (1) | BG66303B1 (en) |
BR (1) | BR0210537A (en) |
CA (1) | CA2450961C (en) |
CO (1) | CO5550423A2 (en) |
CY (1) | CY1105223T1 (en) |
CZ (1) | CZ302786B6 (en) |
DE (1) | DE50207943D1 (en) |
DK (1) | DK1401445T3 (en) |
EA (1) | EA005813B1 (en) |
EE (1) | EE05316B1 (en) |
EG (1) | EG24851A (en) |
ES (1) | ES2271280T3 (en) |
HK (1) | HK1068540A1 (en) |
HR (1) | HRP20031066B1 (en) |
HU (1) | HUP0400333A3 (en) |
IL (2) | IL159238A0 (en) |
ME (1) | ME00412B (en) |
MX (1) | MXPA03011718A (en) |
MY (1) | MY122779A (en) |
NO (1) | NO334301B1 (en) |
NZ (1) | NZ530690A (en) |
PE (2) | PE20030130A1 (en) |
PL (1) | PL208137B1 (en) |
PT (1) | PT1401445E (en) |
RS (1) | RS50441B (en) |
SA (1) | SA02230255B1 (en) |
SI (1) | SI1401445T1 (en) |
SK (1) | SK287262B6 (en) |
TW (2) | TWI261589B (en) |
UY (1) | UY27342A1 (en) |
WO (1) | WO2003000265A1 (en) |
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US7056916B2 (en) | 2002-11-15 | 2006-06-06 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Medicaments for the treatment of chronic obstructive pulmonary disease |
US20050038004A1 (en) * | 2003-07-31 | 2005-02-17 | Robinson Cynthia B. | Combination of dehydroepiandrosterone or dehydroepiandrosterone-sulfate with an anticholinergic bronchodilator for treatment of asthma or chronic obstructive pulmonary disease |
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US7220742B2 (en) | 2004-05-14 | 2007-05-22 | Boehringer Ingelheim International Gmbh | Enantiomerically pure beta agonists, process for the manufacture thereof and use thereof as medicaments |
DE102004024454A1 (en) | 2004-05-14 | 2005-12-08 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Novel enantiomerically pure beta agonists, process for their preparation and their use as pharmaceuticals |
EP1632229B1 (en) | 2004-08-11 | 2009-04-01 | Boehringer Ingelheim Pharma GmbH & Co. KG | Medicaments for the treatment of urinary tract disorders comprising anticholinergic agents |
US20060079544A1 (en) * | 2004-08-13 | 2006-04-13 | Boehringer Ingelheim International Gmbh | Medicaments for the prevention or treatment of alveolar pneumonia comprising an anticholinergic |
DE102004048389A1 (en) | 2004-10-01 | 2006-04-06 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Modification of surfaces of lactose as adjuvant for use with powder inhalants |
EA013239B1 (en) | 2005-04-28 | 2010-04-30 | Бёрингер Ингельхайм Интернациональ Гмбх | Novel compounds for treating inflammatory diseases |
RU2007144531A (en) * | 2005-05-02 | 2009-06-10 | БЕРИНГЕР ИНГЕЛЬХАЙМ ИНТЕРНАЦИОНАЛЬ ГмбХ (DE) | NEW CRYSTAL FORMS OF THIOTROPYBROMIDE |
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US20070086957A1 (en) | 2005-10-10 | 2007-04-19 | Thierry Bouyssou | Combination of medicaments for the treatment of respiratory diseases |
US7423146B2 (en) | 2005-11-09 | 2008-09-09 | Boehringer Ingelheim International Gmbh | Process for the manufacturing of pharmaceutically active 3,1-benzoxazine-2-ones |
US9108962B2 (en) | 2005-12-19 | 2015-08-18 | Sicor, Inc. | Forms of tiotropium bromide and processes for preparation thereof |
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EP1847543A1 (en) | 2006-04-19 | 2007-10-24 | Boehringer Ingelheim Pharma GmbH & Co. KG | Dihydrothienopyrimidines for the treatment of inflammatory diseases |
ES2360963T3 (en) | 2006-08-07 | 2011-06-10 | Boehringer Ingelheim International Gmbh | COMBINATIONS OF DRUGS FOR THE TREATMENT OF DISEASES OF THE RESPIRATORY ROUTES. |
PE20080610A1 (en) | 2006-08-22 | 2008-07-15 | Boehringer Ingelheim Int | NEW ENANTHOMERICALLY PURE BETA-AGONISTS, PROCEDURES FOR THEIR PREPARATION AND USE AS MEDICINES |
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CZ304368B6 (en) | 2011-11-28 | 2014-04-02 | Zentiva, K.S. | Tiotropium bromide mixed solvate and process for preparing thereof |
GB201200525D0 (en) | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
PT106142B (en) * | 2012-02-10 | 2014-07-18 | Hovione Farmaci Ncia S A | PROCESS FOR THE PREPARATION OF TIOTROPE BROMIDE |
US9096579B2 (en) | 2012-04-20 | 2015-08-04 | Boehringer Ingelheim International Gmbh | Amino-indolyl-substituted imidazolyl-pyrimidines and their use as medicaments |
EP2897955B1 (en) * | 2012-09-11 | 2019-11-06 | Bilgic, Mahmut | New tiotropium bromide crystalline form |
PL2914593T3 (en) | 2012-11-05 | 2017-07-31 | Zentiva, K.S. | Stabilization of tiotropium solvates |
CN104341412A (en) * | 2013-07-29 | 2015-02-11 | 天津金耀集团有限公司 | Anhydrous tiotropium bromide crystal preparation method |
JP6599884B2 (en) | 2014-03-19 | 2019-10-30 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | Novel heteroaryl compounds and their use as medicaments |
US10034866B2 (en) | 2014-06-19 | 2018-07-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Inhalable medicament comprising tiotropium |
EA035145B1 (en) | 2014-10-21 | 2020-05-06 | Ариад Фармасьютикалз, Инк. | Crystalline forms of 5-chloro-n4-[-2-(dimethylphosphoryl)phenyl]-n2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]pyrimidine-2,4-diamine |
WO2017138896A1 (en) * | 2016-02-11 | 2017-08-17 | Sima Patent Ve Lisanslama Hizmetleri Ltd. Şti | Crystalline form of tiotropium bromide anhydrate |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3931041C2 (en) * | 1989-09-16 | 2000-04-06 | Boehringer Ingelheim Kg | Esters of thienyl carboxylic acids with amino alcohols, their quaternization products, processes for their preparation and medicaments containing them |
AU2002214996B2 (en) * | 2000-10-12 | 2007-03-15 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament |
DE10064816A1 (en) * | 2000-12-22 | 2002-06-27 | Boehringer Ingelheim Pharma | Production of tiotropium bromide useful as an anticholinergic comprises oxidation of di-(2-thienyl)-glycolic acid tropenol ester and subsequent quaternisation |
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2002
- 2002-06-08 EE EEP200400029A patent/EE05316B1/en unknown
- 2002-06-08 ES ES02743165T patent/ES2271280T3/en not_active Expired - Lifetime
- 2002-06-08 HU HU0400333A patent/HUP0400333A3/en unknown
- 2002-06-08 CN CN02812303A patent/CN100586948C/en not_active Expired - Lifetime
- 2002-06-08 DE DE50207943T patent/DE50207943D1/en not_active Expired - Lifetime
- 2002-06-08 RS YUP-997/03A patent/RS50441B/en unknown
- 2002-06-08 MX MXPA03011718A patent/MXPA03011718A/en active IP Right Grant
- 2002-06-08 KR KR1020037016769A patent/KR100971616B1/en active IP Right Grant
- 2002-06-08 PL PL364489A patent/PL208137B1/en unknown
- 2002-06-08 NZ NZ530690A patent/NZ530690A/en not_active IP Right Cessation
- 2002-06-08 SK SK52-2004A patent/SK287262B6/en unknown
- 2002-06-08 SI SI200230431T patent/SI1401445T1/en unknown
- 2002-06-08 WO PCT/EP2002/006291 patent/WO2003000265A1/en active Application Filing
- 2002-06-08 ME MEP-2008-620A patent/ME00412B/en unknown
- 2002-06-08 DK DK02743165T patent/DK1401445T3/en active
- 2002-06-08 IL IL15923802A patent/IL159238A0/en unknown
- 2002-06-08 CA CA2450961A patent/CA2450961C/en not_active Expired - Fee Related
- 2002-06-08 KR KR1020097004823A patent/KR101011353B1/en active IP Right Grant
- 2002-06-08 AT AT02743165T patent/ATE337006T1/en active
- 2002-06-08 PT PT02743165T patent/PT1401445E/en unknown
- 2002-06-08 EA EA200301293A patent/EA005813B1/en not_active IP Right Cessation
- 2002-06-08 JP JP2003506910A patent/JP2005504015A/en active Pending
- 2002-06-08 BR BR0210537-3A patent/BR0210537A/en active Pending
- 2002-06-08 EP EP02743165A patent/EP1401445B1/en not_active Expired - Lifetime
- 2002-06-08 CZ CZ20040120A patent/CZ302786B6/en not_active IP Right Cessation
- 2002-06-08 AU AU2002345016A patent/AU2002345016B2/en not_active Expired
- 2002-06-19 TW TW091113373A patent/TWI261589B/en not_active IP Right Cessation
- 2002-06-19 EG EG2002060698A patent/EG24851A/en active
- 2002-06-19 TW TW095100968A patent/TW200617007A/en unknown
- 2002-06-20 UY UY27342A patent/UY27342A1/en not_active Application Discontinuation
- 2002-06-20 MY MYPI20022316A patent/MY122779A/en unknown
- 2002-06-21 AR ARP020102337A patent/AR037491A1/en not_active Ceased/Invalidation/Refusal/Rejection/Nullification
- 2002-06-21 PE PE2002000538A patent/PE20030130A1/en active IP Right Grant
- 2002-06-21 PE PE2007000660A patent/PE20081305A1/en not_active Application Discontinuation
- 2002-08-19 SA SA2230255A patent/SA02230255B1/en unknown
-
2003
- 2003-12-08 IL IL159238A patent/IL159238A/en active IP Right Grant
- 2003-12-12 BG BG108440A patent/BG66303B1/en active Active
- 2003-12-19 HR HR20031066A patent/HRP20031066B1/en not_active IP Right Cessation
- 2003-12-19 NO NO20035696A patent/NO334301B1/en not_active IP Right Cessation
-
2004
- 2004-01-20 CO CO04003764A patent/CO5550423A2/en not_active Application Discontinuation
-
2005
- 2005-01-29 HK HK05100780.9A patent/HK1068540A1/en not_active IP Right Cessation
-
2006
- 2006-09-20 CY CY20061101339T patent/CY1105223T1/en unknown
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