HRP20160363T1 - Soli desfesoterodina - Google Patents
Soli desfesoterodina Download PDFInfo
- Publication number
- HRP20160363T1 HRP20160363T1 HRP20160363TT HRP20160363T HRP20160363T1 HR P20160363 T1 HRP20160363 T1 HR P20160363T1 HR P20160363T T HRP20160363T T HR P20160363TT HR P20160363 T HRP20160363 T HR P20160363T HR P20160363 T1 HRP20160363 T1 HR P20160363T1
- Authority
- HR
- Croatia
- Prior art keywords
- desfesoterodine
- succinate
- salt
- succinate salt
- pharmaceutical
- Prior art date
Links
- DUXZAXCGJSBGDW-HXUWFJFHSA-N Desfesoterodine Chemical class C1([C@@H](CCN(C(C)C)C(C)C)C=2C(=CC=C(CO)C=2)O)=CC=CC=C1 DUXZAXCGJSBGDW-HXUWFJFHSA-N 0.000 title claims 11
- FRPJDSBXTGYKRS-VEIFNGETSA-N butanedioic acid 2-[(1R)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenol Chemical class OC(=O)CCC(O)=O.C1([C@@H](CCN(C(C)C)C(C)C)C=2C(=CC=C(CO)C=2)O)=CC=CC=C1 FRPJDSBXTGYKRS-VEIFNGETSA-N 0.000 claims 10
- 229950002488 desfesoterodine Drugs 0.000 claims 10
- 150000003890 succinate salts Chemical class 0.000 claims 9
- 239000007787 solid Substances 0.000 claims 8
- 239000000825 pharmaceutical preparation Substances 0.000 claims 6
- 150000003839 salts Chemical class 0.000 claims 4
- 238000000634 powder X-ray diffraction Methods 0.000 claims 3
- 238000001938 differential scanning calorimetry curve Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 2
- 206010020853 Hypertonic bladder Diseases 0.000 claims 1
- 208000009722 Overactive Urinary Bladder Diseases 0.000 claims 1
- 206010046543 Urinary incontinence Diseases 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 208000020629 overactive bladder Diseases 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000001384 succinic acid Substances 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C215/00—Compounds containing amino and hydroxy groups bound to the same carbon skeleton
- C07C215/46—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton
- C07C215/48—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups
- C07C215/54—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups linked by carbon chains having at least three carbon atoms between the amino groups and the six-membered aromatic ring or the condensed ring system containing that ring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C55/00—Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
- C07C55/02—Dicarboxylic acids
- C07C55/10—Succinic acid
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
- C07C59/235—Saturated compounds containing more than one carboxyl group
- C07C59/245—Saturated compounds containing more than one carboxyl group containing hydroxy or O-metal groups
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Urology & Nephrology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (15)
1. Sukcinatna sol desfesoterodina.
2. Sukcinatna sol desfesoterodina prema zahtjevu 1, gdje je sukcinatna sol u bezvodnom obliku.
3. Sukcinatna sol prema zahtjevu 1, gdje je sukcinatna sol desfesoterodina u čvrstom obliku.
4. Sukcinatna sol desfesoterodina prema bilo kojem od zahtjeva 1 do 3, gdje je molarni omjer između desfesoterodina i sukcinatne kiseline 1:1 do 1:1.5, odnosno poželjno oko 1:1.
5. Sukcinatna sol desfesoterodina prema bilo kojem od zahtjeva 1 do 4, čija je kemijska čistoća najmanje 95%, >98%, ili čak >99% mjereno HPLC/UV (% površine).
6. Sukcinatna sol desfesoterodina prema bilo kojem od zahtjeva 1 do 5, gdje je sol u kristaliničnom obliku.
7. Kristalinična sukcinatna sol desfesoterodina prema zahtjevu 6, gdje je kristalinični oblik desfesoterodin sukcinata, označenog kao Oblik S1, naznačen podacima izabranima između jednog ili više od sljedećeg: obrazac rendgenske difrakcije praha ima pikove na 7.4, 16.8, 18.0, 21.7 i 27.4 stupnja dva theta ± 0.2 stupnja dva theta; obrazac rendgenske difrakcije praha u biti je kakav je prikazan na Slici 5; i njihove kombinacije.
8. Kristalinična sukcinatna sol desfesoterodina prema zahtjevu 7, gdje je kristalinični oblik desfesoterodin sukcinata dalje naznačen podacima izabranima između: obrazac rendgenske difrakcije praha ima bilo koji jedan, dva, tri, četiri ili pet dodatnih pikova izabranih između pikova na 9.3, 12.2, 14.6, 19.6 i 24.5 stupnja dva theta ± 0.2 stupnja dva theta; DSC krivulja ima endotermni pik na oko 169°C ±2, DSC krivulja u biti je kakva je prikazana na Slici 3; i njihove kombinacije.
9. Postupak pripreme drugih soli desfesoterodina, koji obuhvaća pripremu bilo koje od sukcinatnih soli desfesoterodina i njihovih oblika u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8, i pretvorbu te soli u drugu sol desfesoterodina.
10. Farmaceutski pripravak koji sadrži bilo koju ili kombinaciju sukcinatnih soli desfesoterodina i/ili njihovih oblika u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8.
11. Uporaba sukcinatnih soli desfesoterodina i/ili njihovih oblika u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8 za pripremu farmaceutskog pripravka.
12. Farmaceutski oblik koji sadrži bilo koju ili kombinaciju sukcinatnih soli desfesoterodina i/ili njihovih oblika u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8, ili farmaceutski pripravak prema zahtjevu 10, i barem jednu farmaceutski prikladnu pomoćnu tvar.
13. Postupak pripreme farmaceutskog oblika koji sadrži kombiniranje bilo koje ili kombinacije sukcinatnih soli desfesoterodina i/ili njihovih oblika u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8, ili farmaceutski pripravak prema zahtjevu 10, i barem jednu farmaceutski prikladnu pomoćnu tvar.
14. Sukcinatna sol desfesoterodina i/ili njezin oblik u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8, ili farmaceutski pripravak prema zahtjevu 10, ili farmaceutski oblik prema zahtjevu 12, za uporabu kao lijek.
15. Sukcinatna sol desfesoterodina i/ili njezin oblik u čvrstom stanju prema bilo kojem od zahtjeva 1 do 8, farmaceutski pripravak prema zahtjevu 10, ili farmaceutski oblik prema zahtjevu 12 za uporabu u liječenju urinarne inkontinencije i prekomjerno aktivnog mjehura.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261659829P | 2012-06-14 | 2012-06-14 | |
| US201361818135P | 2013-05-01 | 2013-05-01 | |
| PCT/US2013/045992 WO2013188829A1 (en) | 2012-06-14 | 2013-06-14 | Desfesoterodine salts |
| EP13739534.9A EP2760822B1 (en) | 2012-06-14 | 2013-06-14 | Desfesoterodine salts |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160363T1 true HRP20160363T1 (hr) | 2016-06-17 |
Family
ID=48808499
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160363TT HRP20160363T1 (hr) | 2012-06-14 | 2016-04-08 | Soli desfesoterodina |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US9315450B2 (hr) |
| EP (1) | EP2760822B1 (hr) |
| CA (1) | CA2875342C (hr) |
| ES (1) | ES2569201T3 (hr) |
| HR (1) | HRP20160363T1 (hr) |
| PL (1) | PL2760822T3 (hr) |
| WO (1) | WO2013188829A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017137955A1 (en) * | 2016-02-14 | 2017-08-17 | Celestis Pharmaceuticals Pvt. Ltd. | Novel (r) and rac 3-(2-(allyloxy)-5-methylphenyl)-n,n-diisopropyl-3- phenylpropan-1-amine and its use for synthesis of (r) and rac-2-(3- (diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9203318D0 (sv) | 1992-11-06 | 1992-11-06 | Kabi Pharmacia Ab | Novel 3,3-diphenylpropylamines, their use and preparation |
| EP0957073A1 (en) | 1998-05-12 | 1999-11-17 | Schwarz Pharma Ag | Novel derivatives of 3,3-diphenylpropylamines |
| DE10028443C1 (de) | 2000-06-14 | 2002-05-29 | Sanol Arznei Schwarz Gmbh | Verfahren zur Herstellung von 3,3-Diarylpropylaminen, (R,S)- und (R)-4-Phenyl-2-chromanon-6-carbonsäure sowie (R)-4-Phenyl-2-chromanon-carbonsäure-cinchonidinsalz und deren Verwendung zur Herstellung eines rechtsdrehenden Hydroxybenzylalkohols und von pharmazeutischen Zusammensetzungen |
| CA2651978C (en) | 2006-05-24 | 2011-06-07 | Pfizer Limited | Process for the production of benzopyran-2-ol derivatives |
| GB0813762D0 (en) | 2008-07-28 | 2008-09-03 | Moseley Darren C | Slatted wall fixing element |
| KR20120014583A (ko) | 2009-05-11 | 2012-02-17 | 라티오팜 게엠베하 | 타르타르산 염 형태의 데스페소테로딘 |
| WO2011158257A1 (en) | 2010-06-18 | 2011-12-22 | Panacea Biotec Ltd | Preparation process of fesoterodine and intermediates |
-
2013
- 2013-06-14 WO PCT/US2013/045992 patent/WO2013188829A1/en active Application Filing
- 2013-06-14 EP EP13739534.9A patent/EP2760822B1/en not_active Not-in-force
- 2013-06-14 US US14/406,649 patent/US9315450B2/en not_active Expired - Fee Related
- 2013-06-14 ES ES13739534.9T patent/ES2569201T3/es active Active
- 2013-06-14 PL PL13739534.9T patent/PL2760822T3/pl unknown
- 2013-06-14 CA CA2875342A patent/CA2875342C/en not_active Expired - Fee Related
-
2016
- 2016-04-08 HR HRP20160363TT patent/HRP20160363T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| ES2569201T3 (es) | 2016-05-09 |
| CA2875342A1 (en) | 2013-12-19 |
| US20150152044A1 (en) | 2015-06-04 |
| PL2760822T3 (pl) | 2016-09-30 |
| EP2760822B1 (en) | 2016-03-23 |
| US9315450B2 (en) | 2016-04-19 |
| EP2760822A1 (en) | 2014-08-06 |
| WO2013188829A1 (en) | 2013-12-19 |
| CA2875342C (en) | 2017-06-13 |
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