DK2914593T3 - Stabilisering af tiotropium-solvater - Google Patents
Stabilisering af tiotropium-solvater Download PDFInfo
- Publication number
- DK2914593T3 DK2914593T3 DK12786801.6T DK12786801T DK2914593T3 DK 2914593 T3 DK2914593 T3 DK 2914593T3 DK 12786801 T DK12786801 T DK 12786801T DK 2914593 T3 DK2914593 T3 DK 2914593T3
- Authority
- DK
- Denmark
- Prior art keywords
- solvate
- solvates
- tiotropium bromide
- propanediol
- ethanol
- 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
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Pulmonology (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)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Steroid Compounds (AREA)
- Medicinal Preparation (AREA)
- Cleaning And De-Greasing Of Metallic Materials By Chemical Methods (AREA)
- Emergency Medicine (AREA)
- Epidemiology (AREA)
- Inorganic Compounds Of Heavy Metals (AREA)
Claims (7)
1. Fremgangsmåde til stabilisering af mikroniserede eller formalede solvater af tiotropiumbromid, udvalgt blandt solvater med methanol, ethanol, 2-propanol, 1,2-propandiol, 1,3-propandiol, n-butanol, 1,4-butandiol og tert-butanol, kendetegnet ved, at solvaterne aflejres i en mættet atmosfære af det passende opløsningsmiddel i det tidsrum, der er tilstrækkeligt til genindvinding af opløsningsmidlet.
2. Fremgangsmåde ifølge krav 1, kendetegnet ved, at solvaterne har en D50 i området 1-10 pm.
3. Fremgangsmåde ifølge krav 1, kendetegnet ved, at solvaterne aflejres i en lukket beholder, hvor der påføres vakuum til opnåelse af en mættet atmosfære af det passende opløsningsmiddel.
4. Tiotropiumbromid-solvat med 1,3-propandiol.
5. Tiotropiumbromide-solvat ifølge krav 4, som har et pulverrøntgendiffraktionsspektrum med hoved-peaks (+/-0,2° 2Theta) 11,0; 15,3; 18,0; 21,4; 25,0, målt under anvendelse af CuKa.
6. Tiotropiumbromid-solvat ifølge krav 5, som har et pulverrøntgendiffraktionsspektrum med de øvrige karakteristiske peaks (+/-0,2° 2Theta) 9,9; 13,4; 16,3; 19,8; 20,9; 23,5; 23,9; 24,6; 25,8; 26,0; 27,0; 27,8; 31,8.
7. Fremgangsmåde til fremstilling af tiotropiumbromid-solvatet ifølge krav 4-6, kendetegnet ved, at tiotropiumbromid opløses i 1,3-propandiol ved en temperatur i området fra 40 °C til kogepunktet, opløsningen afkøles til en temperatur i området fra 0 °C til 10 °C, og det faste solvat frafiltreres.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CZ2012/000112 WO2014067499A1 (en) | 2012-11-05 | 2012-11-05 | Stabilization of tiotropium solvates |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2914593T3 true DK2914593T3 (da) | 2017-04-18 |
Family
ID=47178436
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK12786801.6T DK2914593T3 (da) | 2012-11-05 | 2012-11-05 | Stabilisering af tiotropium-solvater |
Country Status (24)
| Country | Link |
|---|---|
| EP (1) | EP2914593B1 (da) |
| JP (1) | JP6158939B2 (da) |
| KR (1) | KR20150079671A (da) |
| CN (1) | CN104797579A (da) |
| BR (1) | BR112015009654A2 (da) |
| CY (1) | CY1118828T1 (da) |
| DK (1) | DK2914593T3 (da) |
| EA (1) | EA025960B1 (da) |
| ES (1) | ES2620758T3 (da) |
| HK (1) | HK1207625A1 (da) |
| HR (1) | HRP20170523T1 (da) |
| HU (1) | HUE032455T2 (da) |
| IL (1) | IL238503A0 (da) |
| LT (1) | LT2914593T (da) |
| ME (1) | ME02679B (da) |
| MX (1) | MX2015005319A (da) |
| PL (1) | PL2914593T3 (da) |
| PT (1) | PT2914593T (da) |
| RS (1) | RS55919B1 (da) |
| SI (1) | SI2914593T1 (da) |
| SM (1) | SMT201700226T1 (da) |
| UA (1) | UA115888C2 (da) |
| WO (1) | WO2014067499A1 (da) |
| ZA (1) | ZA201503043B (da) |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3931041C2 (de) | 1989-09-16 | 2000-04-06 | Boehringer Ingelheim Kg | Ester von Thienylcarbonsäuren mit Aminoalkoholen, ihre Quaternierungsprodukte, Verfahren zu ihrer Herstellung und diese enthaltende Arzneimittel |
| DE50103666D1 (de) | 2000-10-12 | 2004-10-21 | Boehringer Ingelheim Pharma | Kristallines monohydrat von tiotropiumbromid, verfahren zu dessen herstellung und dessen verwendung zur herstellung eines arzneimittels |
| PL208137B1 (pl) | 2001-06-22 | 2011-03-31 | Boehringer Ingelheim Pharma | Bezwodny krystaliczny bromek tiotropium, sposób jego wytwarzania i zastosowanie krystalicznego monohydratu bromku tiotropium do wytwarzania krystalicznego bezwodnego bromku tiotropium |
| CN100509809C (zh) | 2003-11-03 | 2009-07-08 | 贝林格尔·英格海姆国际有限公司 | 具有抗胆碱能作用的新颖无水晶体 |
| JP5227790B2 (ja) * | 2005-05-02 | 2013-07-03 | 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 | 新規結晶性臭化チオトロピウム |
| EP1879888A2 (en) * | 2005-05-02 | 2008-01-23 | Boehringer Ingelheim International GmbH | Crystalline forms of tiotropium bromide |
| SI1869035T2 (sl) * | 2005-12-19 | 2015-12-31 | Sicor, Inc. | Nove kristalne oblike tiotropij bromida in postopek njihove priprave |
| KR101395881B1 (ko) | 2005-12-19 | 2014-05-21 | 시코르, 인크. | 브롬화 티오트로피움의 신규한 형태 및 이의 제조 방법 |
| EP2403851B1 (en) * | 2009-03-06 | 2015-06-17 | Mahmut Bilgic | New crystalline forms of tiotropium bromide |
| WO2011015883A1 (en) | 2009-08-07 | 2011-02-10 | Generics [Uk] Limited | Dichloromethane solvate of tiotropium bromide and its use |
-
2012
- 2012-11-05 ME MEP-2017-86A patent/ME02679B/me unknown
- 2012-11-05 ES ES12786801.6T patent/ES2620758T3/es active Active
- 2012-11-05 PL PL12786801T patent/PL2914593T3/pl unknown
- 2012-11-05 RS RS20170356A patent/RS55919B1/sr unknown
- 2012-11-05 DK DK12786801.6T patent/DK2914593T3/da active
- 2012-11-05 HK HK15108182.4A patent/HK1207625A1/xx unknown
- 2012-11-05 KR KR1020157011520A patent/KR20150079671A/ko not_active Withdrawn
- 2012-11-05 JP JP2015541008A patent/JP6158939B2/ja active Active
- 2012-11-05 WO PCT/CZ2012/000112 patent/WO2014067499A1/en not_active Ceased
- 2012-11-05 LT LTEP12786801.6T patent/LT2914593T/lt unknown
- 2012-11-05 EA EA201590872A patent/EA025960B1/ru not_active IP Right Cessation
- 2012-11-05 HU HUE12786801A patent/HUE032455T2/en unknown
- 2012-11-05 CN CN201280076762.9A patent/CN104797579A/zh active Pending
- 2012-11-05 EP EP12786801.6A patent/EP2914593B1/en active Active
- 2012-11-05 SM SM20170226T patent/SMT201700226T1/it unknown
- 2012-11-05 HR HRP20170523TT patent/HRP20170523T1/hr unknown
- 2012-11-05 SI SI201230913A patent/SI2914593T1/sl unknown
- 2012-11-05 UA UAA201505523A patent/UA115888C2/uk unknown
- 2012-11-05 BR BR112015009654A patent/BR112015009654A2/pt active Search and Examination
- 2012-11-05 PT PT127868016T patent/PT2914593T/pt unknown
- 2012-11-05 MX MX2015005319A patent/MX2015005319A/es unknown
-
2015
- 2015-04-28 IL IL238503A patent/IL238503A0/en unknown
- 2015-05-04 ZA ZA2015/03043A patent/ZA201503043B/en unknown
-
2017
- 2017-04-11 CY CY20171100433T patent/CY1118828T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EA025960B1 (ru) | 2017-02-28 |
| SMT201700226T1 (it) | 2017-07-18 |
| PL2914593T3 (pl) | 2017-07-31 |
| EP2914593B1 (en) | 2017-01-11 |
| SI2914593T1 (sl) | 2017-05-31 |
| ZA201503043B (en) | 2016-01-27 |
| JP6158939B2 (ja) | 2017-07-05 |
| CY1118828T1 (el) | 2018-01-10 |
| KR20150079671A (ko) | 2015-07-08 |
| ES2620758T3 (es) | 2017-06-29 |
| HK1207625A1 (en) | 2016-02-05 |
| ME02679B (me) | 2017-06-20 |
| MX2015005319A (es) | 2015-07-14 |
| HRP20170523T1 (hr) | 2017-06-02 |
| HUE032455T2 (en) | 2017-09-28 |
| JP2016502518A (ja) | 2016-01-28 |
| EP2914593A1 (en) | 2015-09-09 |
| BR112015009654A2 (pt) | 2017-07-04 |
| PT2914593T (pt) | 2017-04-03 |
| CN104797579A (zh) | 2015-07-22 |
| WO2014067499A1 (en) | 2014-05-08 |
| UA115888C2 (uk) | 2018-01-10 |
| RS55919B1 (sr) | 2017-09-29 |
| IL238503A0 (en) | 2015-06-30 |
| EA201590872A1 (ru) | 2015-10-30 |
| LT2914593T (lt) | 2017-04-10 |
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