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HRP20160363T1 - Soli desfesoterodina - Google Patents

Soli desfesoterodina Download PDF

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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
Application number
HRP20160363TT
Other languages
English (en)
Inventor
Simone EICHNER
Wolfgang Albrecht
Original Assignee
Ratiopharm Gmbh
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 Ratiopharm Gmbh filed Critical Ratiopharm Gmbh
Publication of HRP20160363T1 publication Critical patent/HRP20160363T1/hr

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C215/00Compounds containing amino and hydroxy groups bound to the same carbon skeleton
    • C07C215/46Compounds 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
    • C07C215/48Compounds 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
    • C07C215/54Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02Dicarboxylic acids
    • C07C55/10Succinic acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C59/00Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
    • C07C59/235Saturated compounds containing more than one carboxyl group
    • C07C59/245Saturated compounds containing more than one carboxyl group containing hydroxy or O-metal groups

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  • 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.
HRP20160363TT 2012-06-14 2013-06-14 Soli desfesoterodina HRP20160363T1 (hr)

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 2013-06-14 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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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
DK2029567T3 (da) 2006-05-24 2010-11-29 Pfizer Ltd Fremgangsmåde til frembringelse af benzopyran-2-ol-derivater
GB0813762D0 (en) 2008-07-28 2008-09-03 Moseley Darren C Slatted wall fixing element
US9085507B2 (en) 2009-05-11 2015-07-21 Ratiopharm Gmbh Desfesoterodine in the form of a tartaric acid salt
WO2011158257A1 (en) 2010-06-18 2011-12-22 Panacea Biotec Ltd Preparation process of fesoterodine and intermediates

Also Published As

Publication number Publication date
ES2569201T3 (es) 2016-05-09
CA2875342C (en) 2017-06-13
EP2760822A1 (en) 2014-08-06
US9315450B2 (en) 2016-04-19
PL2760822T3 (pl) 2016-09-30
WO2013188829A1 (en) 2013-12-19
US20150152044A1 (en) 2015-06-04
EP2760822B1 (en) 2016-03-23
CA2875342A1 (en) 2013-12-19

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