HRP20180150T1 - Postupak za proizvodnju soli solifenacina i njihova ugradnja u farmaceutske dozne oblike - Google Patents
Postupak za proizvodnju soli solifenacina i njihova ugradnja u farmaceutske dozne oblike Download PDFInfo
- Publication number
- HRP20180150T1 HRP20180150T1 HRP20180150TT HRP20180150T HRP20180150T1 HR P20180150 T1 HRP20180150 T1 HR P20180150T1 HR P20180150T T HRP20180150T T HR P20180150TT HR P20180150 T HRP20180150 T HR P20180150T HR P20180150 T1 HRP20180150 T1 HR P20180150T1
- Authority
- HR
- Croatia
- Prior art keywords
- phenyl
- tetrahydroisoquinoline
- potassium
- sodium
- production
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 5
- FBOUYBDGKBSUES-VXKWHMMOSA-N solifenacin Chemical class C1([C@H]2C3=CC=CC=C3CCN2C(O[C@@H]2C3CCN(CC3)C2)=O)=CC=CC=C1 FBOUYBDGKBSUES-VXKWHMMOSA-N 0.000 title claims 3
- 239000002552 dosage form Substances 0.000 title 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims 5
- 229910052700 potassium Inorganic materials 0.000 claims 5
- 239000011591 potassium Substances 0.000 claims 5
- 150000001875 compounds Chemical class 0.000 claims 4
- PRTRSEDVLBBFJZ-HNNXBMFYSA-N (1s)-1-phenyl-1,2,3,4-tetrahydroisoquinoline Chemical compound C1([C@H]2C3=CC=CC=C3CCN2)=CC=CC=C1 PRTRSEDVLBBFJZ-HNNXBMFYSA-N 0.000 claims 3
- SWBVIRQAWXCRKV-RSAXXLAASA-N (1s)-1-phenyl-1,2,3,4-tetrahydroisoquinoline;sodium Chemical group [Na].C1([C@H]2C3=CC=CC=C3CCN2)=CC=CC=C1 SWBVIRQAWXCRKV-RSAXXLAASA-N 0.000 claims 3
- QTTGTMVPAJAYHD-UHFFFAOYSA-N 1-phenyl-1,2,3,4-tetrahydroisoquinoline;potassium Chemical group [K].N1CCC2=CC=CC=C2C1C1=CC=CC=C1 QTTGTMVPAJAYHD-UHFFFAOYSA-N 0.000 claims 3
- SWBVIRQAWXCRKV-UHFFFAOYSA-N 1-phenyl-1,2,3,4-tetrahydroisoquinoline;sodium Chemical group [Na].N1CCC2=CC=CC=C2C1C1=CC=CC=C1 SWBVIRQAWXCRKV-UHFFFAOYSA-N 0.000 claims 3
- CTOQBSUYGFNMJX-UHFFFAOYSA-N 1-phenyl-3,4-dihydroisoquinoline Chemical compound N=1CCC2=CC=CC=C2C=1C1=CC=CC=C1 CTOQBSUYGFNMJX-UHFFFAOYSA-N 0.000 claims 2
- 239000003054 catalyst Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 229960003855 solifenacin Drugs 0.000 claims 2
- PRTRSEDVLBBFJZ-UHFFFAOYSA-N 1-phenyl-1,2,3,4-tetrahydroisoquinoline Chemical compound N1CCC2=CC=CC=C2C1C1=CC=CC=C1 PRTRSEDVLBBFJZ-UHFFFAOYSA-N 0.000 claims 1
- QTTGTMVPAJAYHD-RSAXXLAASA-N [K].C1Cc2ccccc2[C@@H](N1)c1ccccc1 Chemical group [K].C1Cc2ccccc2[C@@H](N1)c1ccccc1 QTTGTMVPAJAYHD-RSAXXLAASA-N 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000003446 ligand Substances 0.000 claims 1
- 229910052751 metal Inorganic materials 0.000 claims 1
- 239000002184 metal Substances 0.000 claims 1
- 229910021645 metal ion Inorganic materials 0.000 claims 1
- 125000002524 organometallic group Chemical group 0.000 claims 1
- 238000000634 powder X-ray diffraction Methods 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D453/00—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids
- C07D453/02—Heterocyclic compounds containing quinuclidine or iso-quinuclidine ring systems, e.g. quinine alkaloids containing not further condensed quinuclidine ring systems
-
- 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
-
- 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
Claims (10)
1. Spoj, naznačen time, da je to kalij-1-fenil-1,2,3,4-tetrahidroizokinolin.
2. Spoj, naznačen time, da je to kalij-1(S)-fenil-1,2,3,4-tetrahidroizokinolin.
3. Kalij-1-fenil-1,2,3,4-tetrahidroizokinolin prema zahtjevu 1, naznačen time, da prikazuje uzorak difrakcije praha X-zraka kao što je prikazano na Slici 1.
4. Kalij-1-fenil-1,2,3,4-tetrahidroizokinolin prema zahtjevima 1 i 3, naznačen time, da prikazuje sljedeće theta stupnjeve: 10,2, 15,3, 17,7, 18,0, 20,6, 22,4, 24,6, 25,8 ± 0,2.
5. Spoj, naznačen time, da je to natrij-1-fenil-1,2,3,4-tetrahidroizokinolin.
6. Spoj, naznačen time, da je to natrij-1(S)-fenil-1,2,3,4-tetrahidroizokinolin.
7. Postupak za proizvodnju 1-fenil-1,2,3,4-tetrahidroizokinolina (II), posebice optički obogaćenog ili optički čistog 1(S)-fenil-1,2,3,4-tetrahidroizokinolina (II), naznačen time, da se 1-fenil-3,4-dihidroizokinolin (IV) reducira s hidrogenirajućim sredstvom u prisutnosti katalizatora, posebice jednog asimetričnog organometalnog molekularnog katalizatora koji obuhvaća metalni atom ili metalni ion koji ima jednoga ili više kiralnih liganda spojenih na njega.
8. Postupak za proizvodnju kalijevog ili natrijevog 1-fenil-1,2,3,4-tetrahidroizokinolina, posebice optički obogaćenog ili optički čistog kalijevog ili natrijevog 1(S)-fenil-1,2,3,4-tetrahidroizokinolina, naznačen time, da se proizvod iz postupka prema zahtjevu 7, pretvara u kalijevu ili natrijevu sol.
9. Uporaba 1(S)-fenil-1,2,3,4-tetrahidroizokinolina (II), posebice optički obogaćenog ili optički čistog 1(S)-fenil-1,2,3,4-tetrahidroizokinolina (II), naznačena time, da se on može dobiti putem postupka prema zahtjevu 7, dok pritom služi za proizvodnju solifenacina ili njegove farmaceutski prihvatljive soli.
10. Uporaba kalijevog ili natrijevog 1-fenil-1,2,3,4-tetrahidroizokinolina (III), posebice optički obogaćenog ili optički čistog kalijevog ili natrijevog 1(S)-fenil-1,2,3,4-tetrahidroizokinolina (III), naznačena time, da on služi za proizvodnju solifenacina ili njegove farmaceutski prihvatljive soli.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SI200800188 | 2008-07-29 | ||
| SI200800285 | 2008-11-20 | ||
| SI200900113 | 2009-04-21 | ||
| EP16156678.1A EP3067353B1 (en) | 2008-07-29 | 2009-07-29 | A process for the preparation of solifenacin salts and their inclusion into pharmaceutical dosage forms |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180150T1 true HRP20180150T1 (hr) | 2018-03-09 |
Family
ID=41610777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20180150TT HRP20180150T1 (hr) | 2008-07-29 | 2018-01-26 | Postupak za proizvodnju soli solifenacina i njihova ugradnja u farmaceutske dozne oblike |
Country Status (5)
| Country | Link |
|---|---|
| EP (2) | EP2310387A2 (hr) |
| HR (1) | HRP20180150T1 (hr) |
| PL (1) | PL3067353T3 (hr) |
| SI (1) | SI3067353T1 (hr) |
| WO (1) | WO2010012459A2 (hr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EA023529B1 (ru) * | 2009-02-27 | 2016-06-30 | КРКА, д.д., НОВО МЕСТО | Способ получения твердых лекарственных форм солифенацина и его фармацевтически приемлемых солей для перорального введения |
| EP2415472A4 (en) * | 2009-03-30 | 2013-02-20 | Astellas Pharma Inc | SOLID PHARMACEUTICAL COMPOSITION WITH SOLUBENACIN AMORPHIC BODY |
| EP2590973B1 (en) | 2010-07-05 | 2016-08-31 | Crystal Pharma, S.A.U. | Solifenacin salts |
| EP2638039A1 (de) * | 2010-11-11 | 2013-09-18 | Hexal AG | Kristallines solifenacin-succinat |
| EP2500013B1 (en) * | 2011-03-15 | 2019-10-02 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Pharmaceutical composition comprising solifenacin |
| EP2778167A1 (en) * | 2013-03-11 | 2014-09-17 | Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi | Stable pharmaceutical composition comprising amorphous solifenacin or its pharmaceutically acceptable salt |
| JP2015189677A (ja) * | 2014-03-27 | 2015-11-02 | テバ製薬株式会社 | ソリフェナシン非晶質体を含有する医薬組成物 |
| CN112552237B (zh) * | 2020-12-23 | 2022-10-14 | 中山奕安泰医药科技有限公司 | 索菲那新中间体的精制方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NO2005012I1 (no) | 1994-12-28 | 2005-06-06 | Debio Rech Pharma Sa | Triptorelin og farmasoytisk akseptable salter derav |
| JP3701964B1 (ja) | 2005-03-08 | 2005-10-05 | アステラス製薬株式会社 | キヌクリジン誘導体の新規な塩 |
| EP1879867A2 (en) | 2005-12-21 | 2008-01-23 | Teva Pharmaceutical Industries Ltd | Intermediates for preparing solifenacin |
| EP2046751A4 (en) | 2006-07-19 | 2010-12-29 | Reddys Lab Ltd Dr | PROCESS FOR PRODUCING SOLIFENACIN AND ITS SALTS |
| EP1943248A2 (en) | 2006-08-03 | 2008-07-16 | Teva Pharmaceutical Industries Ltd. | Solifenacin base forms and preparation thereof |
| CZ300692B6 (cs) | 2006-12-22 | 2009-07-15 | Zentiva, A. S. | Zpusob prípravy solifenacinu |
| EP2229387A1 (en) * | 2007-12-04 | 2010-09-22 | Cadila Healthcare Limited | Process for preparing chemically and chirally pure solifenacin base and its salts |
-
2009
- 2009-07-29 PL PL16156678T patent/PL3067353T3/pl unknown
- 2009-07-29 EP EP09777523A patent/EP2310387A2/en not_active Withdrawn
- 2009-07-29 SI SI200931781T patent/SI3067353T1/en unknown
- 2009-07-29 WO PCT/EP2009/005497 patent/WO2010012459A2/en active Application Filing
- 2009-07-29 EP EP16156678.1A patent/EP3067353B1/en active Active
-
2018
- 2018-01-26 HR HRP20180150TT patent/HRP20180150T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3067353B1 (en) | 2017-11-22 |
| WO2010012459A2 (en) | 2010-02-04 |
| SI3067353T1 (en) | 2018-03-30 |
| WO2010012459A3 (en) | 2010-08-05 |
| EP2310387A2 (en) | 2011-04-20 |
| PL3067353T3 (pl) | 2018-04-30 |
| EP3067353A1 (en) | 2016-09-14 |
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