HRP20141160T1 - Kristali natrijevog lakvinimoda i postupak za njihovu proizvodnju - Google Patents
Kristali natrijevog lakvinimoda i postupak za njihovu proizvodnju Download PDFInfo
- Publication number
- HRP20141160T1 HRP20141160T1 HRP20141160TT HRP20141160T HRP20141160T1 HR P20141160 T1 HRP20141160 T1 HR P20141160T1 HR P20141160T T HRP20141160T T HR P20141160TT HR P20141160 T HRP20141160 T HR P20141160T HR P20141160 T1 HRP20141160 T1 HR P20141160T1
- Authority
- HR
- Croatia
- Prior art keywords
- laquinimod sodium
- mixture
- mixture according
- microns
- total volume
- Prior art date
Links
- 229960004577 laquinimod Drugs 0.000 title claims 16
- GKWPCEFFIHSJOE-UHFFFAOYSA-N laquinimod Chemical compound OC=1C2=C(Cl)C=CC=C2N(C)C(=O)C=1C(=O)N(CC)C1=CC=CC=C1 GKWPCEFFIHSJOE-UHFFFAOYSA-N 0.000 title claims 16
- 238000000034 method Methods 0.000 title claims 6
- 239000013078 crystal Substances 0.000 title claims 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 claims 14
- 239000002245 particle Substances 0.000 claims 6
- 239000000243 solution Substances 0.000 claims 5
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims 4
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 4
- 238000005056 compaction Methods 0.000 claims 4
- 239000012296 anti-solvent Substances 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims 2
- 229910052804 chromium Inorganic materials 0.000 claims 2
- 239000011651 chromium Substances 0.000 claims 2
- 229910001385 heavy metal Inorganic materials 0.000 claims 2
- 229910052742 iron Inorganic materials 0.000 claims 2
- 229910052759 nickel Inorganic materials 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 239000012535 impurity Substances 0.000 claims 1
- 238000011081 inoculation Methods 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 238000001953 recrystallisation Methods 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D215/20—Oxygen atoms
- C07D215/22—Oxygen atoms attached in position 2 or 4
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D215/48—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
- C07D215/54—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3
- C07D215/56—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3 with oxygen atoms in position 4
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
- C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
- C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D215/48—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
- C07D215/54—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen attached in position 3
-
- 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
Claims (17)
1. Smjesa čestica kristalnog natrijevog lakvinimoda, naznačena time, da
i) u njoj 10% ili više od ukupne volumne količine čestica natrijevog lakvinimoda ima veličinu koja je veća od 40 mikrona; ili
ii) ima gustoću zbijenosti od barem 0,6 g/ml.
2. Smjesa prema patentnom zahtjevu 1, naznačena time, da 10% ili više od ukupne volumne količine čestica natrijevog lakvinimoda ima veličinu koja je veća od 40 mikrona i ima gustoću zbijenosti od barem 0,4 g/ml.
3. Smjesa prema patentnom zahtjevu 1, naznačena time, da gustoća zbijenosti jest barem 0,6 g/ml.
4. Smjesa prema patentnom zahtjevu 1, naznačena time, da 10% ili više od ukupne volumne količine čestica natrijevog lakvinimoda ima veličinu koja je veća od 40 mikrona i
a) ima prostornu gustoću od barem 0,2 g/ml, ili
b) ima prostornu gustoću od barem 0,3 g/ml, ili
c) ima gustoću zbijenosti od barem 0,5 g/ml, ili
d) ima gustoću zbijenosti manju od 0,7 g/ml.
5. Smjesa prema bilo kojem od patentnih zahtjeva 1 - 4, naznačena time, da ima prostornu gustoću od barem 0,4 g/ml.
6. Smjesa prema bilo kojem od patentnih zahtjeva 1 - 5, naznačena time, da ima gustoću zbijenosti manju od 0,8 g/ml.
7. Smjesa prema bilo kojem od patentnih zahtjeva 1 - 6, naznačena time, da nema više od 2 ppm teškog metala, računato na bazi ukupne količine natrijevog lakvinimoda u smjesi.
8. Smjesa prema bilo kojem od patentnih zahtjeva 1 - 7, naznačena time, da 10% ili više od ukupne volumne količine čestica natrijevog lakvinimoda ima veličinu koja je veća od 40 mikrona, i u čemu 50% ili više od ukupne volumne količine čestica natrijevog lakvinimoda ima veličinu koja je veća od 15 mikrona.
9. Smjesa prema patentnom zahtjevu 7, naznačena time, da teški metal jest željezo, nikal ili krom.
10. Smjesa prema patentnom zahtjevu 9, naznačena time, da sadrži ne više od 2 ppm željeza, ne više od 0,2 ppm nikla, i/ili ne više od 0,3 ppm kroma.
11. Farmaceutski sastav, naznačen time, da sadrži smjesu prema bilo kojem od patentnih zahtjeva 1-10 i farmaceutski prihvatljiv nosilac.
12. Farmaceutski sastav prema patentnom zahtjevu 11, naznačen time, da jest u obliku tablete ili kapsule.
13. Postupak rekristalizacije natrijevog lakvinimoda, naznačen time, da obuhvaća:
a) otapanje natrijevog lakvinimoda u vodi da se stvori vodena otopina;
b) koncentriranje vodene otopine da se stvori koncentrirana otopina;
c) dodavanje antiotapala, koje se može otapati u vodi, koncentriranoj otopini da se stvore kristali natrijevog lakvinimoda; i
d) izoliranje kristala natrijevog lakvinimoda.
14. Postupak prema patentnom zahtjevu 13, naznačen time, da nadalje obuhvaća stupanj aa), nakon stupnja a), a prije stupnja b), koji navedeni stupanj aa) obuhvaća filtriranje vodene otopine da se odstrane krute nečistoće.
15. Postupak prema patentnom zahtjevu 13 ili 14, naznačen time, da:
i) se u njemu stupanj a) izvodi zagrijavanjem vodene otopine na temperaturu od 40 – 80°C, ili
ii) u njemu nakon stupnja c) slijedi hlađenje otopine na temperaturu ispod 10°C, ili
iii) u njemu nakon stupnja b) slijedi cijepljenje koncentrirane otopine natrijevim lakvinimodom ili bilo kojom kombinacijom od i), ii) ili iii).
16. Postupak prema bilo kojem od patentnih zahtjevu 13 - 15, naznačen time, da:
i) u njemu koncentrirana otopina sadrži 1 - 4 mililitara, prvenstveno 1 - 2 mililitra vode po gramu natrijevog lakvinimoda, ili
ii) je u njemu antiotapalo jedno ili smjesa više od jednog iz skupine koja obuhvaća etanol, izopropanol i aceton, ili
iii) se u njemu antiotapalo dodaje u količini između 3 i 15 mililitara po gramu natrijevog lakvinimoda, ili bilo koja kombinacija od i), ii) i iii).
17. Smjesa kristalnog natrijevog lakvinimoda, naznačena time, da je pripremljena postupkom prema bilo kojem od patentnih zahtjeva 13 – 16.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US72865705P | 2005-10-19 | 2005-10-19 | |
| PCT/US2006/040925 WO2007047863A2 (en) | 2005-10-19 | 2006-10-18 | Crystals of laquinimod sodium, and process for the manufacture thereof |
| EP06826297.1A EP1937642B1 (en) | 2005-10-19 | 2006-10-18 | Crystals of laquinimod sodium, and process for the manufacture thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20141160T1 true HRP20141160T1 (hr) | 2015-01-16 |
Family
ID=37963287
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20141160TT HRP20141160T1 (hr) | 2005-10-19 | 2014-11-28 | Kristali natrijevog lakvinimoda i postupak za njihovu proizvodnju |
Country Status (24)
| Country | Link |
|---|---|
| US (4) | US7884208B2 (hr) |
| EP (2) | EP1937642B1 (hr) |
| JP (3) | JP5832716B2 (hr) |
| KR (1) | KR101440982B1 (hr) |
| CN (3) | CN107176923A (hr) |
| AR (1) | AR056708A1 (hr) |
| AU (1) | AU2006304672B2 (hr) |
| BR (1) | BRPI0617477A2 (hr) |
| CA (1) | CA2625287C (hr) |
| DK (1) | DK1937642T3 (hr) |
| ES (1) | ES2523762T3 (hr) |
| HK (1) | HK1117160A1 (hr) |
| HR (1) | HRP20141160T1 (hr) |
| IL (1) | IL190137A (hr) |
| NZ (2) | NZ592897A (hr) |
| PL (1) | PL1937642T3 (hr) |
| PT (1) | PT1937642E (hr) |
| RS (1) | RS53666B1 (hr) |
| RU (1) | RU2415841C2 (hr) |
| SG (1) | SG10201508623RA (hr) |
| SI (1) | SI1937642T1 (hr) |
| UA (1) | UA92761C2 (hr) |
| WO (1) | WO2007047863A2 (hr) |
| ZA (1) | ZA200803527B (hr) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8314124B2 (en) | 2004-02-06 | 2012-11-20 | Active Biotech Ab | Crystalline salts of quinoline compounds and methods for preparing them |
| JP5832716B2 (ja) * | 2005-10-19 | 2015-12-16 | テバ ファーマシューティカル インダストリーズ リミティド | ラキニモドナトリウムの結晶，及びその製造方法 |
| KR20160013273A (ko) | 2006-06-12 | 2016-02-03 | 테바 파마슈티컬 인더스트리즈 리미티드 | 안정한 라퀴니모드 제제 |
| PT2682120T (pt) * | 2007-12-20 | 2016-11-07 | Teva Pharma | Preparações de laquinimod estáveis |
| WO2010001257A2 (en) * | 2008-07-01 | 2010-01-07 | Actavis Group Ptc Ehf | Novel solid state forms of laquinimod and its sodium salt |
| KR20110048571A (ko) * | 2008-09-03 | 2011-05-11 | 테바 파마슈티컬 인더스트리즈 리미티드 | 면역 기능을 지닌 ２―옥소―１,２―다이하이드로―퀴놀린 조절제 |
| US20120009226A1 (en) | 2008-12-17 | 2012-01-12 | Actavis Group Ptc Ehf | Highly pure laquinimod or a pharmaceutically acceptable salt thereof |
| DE102010048788A1 (de) | 2009-02-13 | 2011-05-19 | Amw Gmbh | Transdermales System mit Immunmodulator |
| DE102009008851A1 (de) | 2009-02-13 | 2010-08-19 | Amw Gmbh | Transdermales System mit Immunmodulator |
| EP3028572A1 (en) | 2009-06-19 | 2016-06-08 | Teva Pharmaceutical Industries, Ltd. | Treatment of multiple sclerosis with laquinimod |
| EA025468B1 (ru) * | 2009-07-30 | 2016-12-30 | Тева Фармасьютикал Индастриз Лтд. | Лечение болезни крона с применением лаквинимода |
| PL3064206T3 (pl) | 2009-08-10 | 2020-02-28 | Active Biotech Ab | Leczenie choroby Huntingtona z zastosowaniem lakwinimodu |
| DE102010026879A1 (de) | 2010-02-11 | 2011-08-11 | AMW GmbH, 83627 | Transdermales System mit Immunmodulator |
| JP2013521305A (ja) * | 2010-03-03 | 2013-06-10 | テバ ファーマシューティカル インダストリーズ リミティド | ラキニモドを用いるループス関節炎の治療 |
| CA2791691A1 (en) | 2010-03-03 | 2011-09-09 | Teva Pharmaceutical Industries Ltd. | Treatment of lupus nephritis using laquinimod |
| CA2791709A1 (en) * | 2010-03-03 | 2011-09-09 | Teva Pharmaceutical Industries Ltd. | Treatment of rheumatoid arthritis with a combination of laquinimod and methotrexate |
| SG186948A1 (en) * | 2010-07-09 | 2013-02-28 | Teva Pharma | Deuterated n-ethyl-n-phenyl-1,2-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-3-carboxamide, salts and uses thereof |
| US20120010239A1 (en) | 2010-07-09 | 2012-01-12 | Ulf Tomas Fristedt | 5-chloro-4-hydroxy-1-methyl-2-oxo-n-phenyl-1,2-dihydroquinoline-3-carboxamide, salts and uses thereof |
| CN103249306A (zh) | 2010-11-28 | 2013-08-14 | Mapi医药公司 | 中间体化合物以及用于制备喹啉衍生物如拉喹莫德钠的方法 |
| WO2013055907A1 (en) * | 2011-10-12 | 2013-04-18 | Teva Pharmaceutical Industries Ltd. | Treatment of multiple sclerosis with combination of laquinimod and fingolimod |
| AR089862A1 (es) | 2012-02-03 | 2014-09-24 | Teva Pharma | USO DE LAQUINIMOD PARA EL TRATAMIENTO DE PACIENTES CON ENFERMEDAD DE CROHN EN QUIENES FRACASO UNA TERAPIA ANTI-FACTOR DE NECROSIS TUMORAL a (ANTI-TNFa) DE PRIMERA LINEA |
| WO2013123419A1 (en) * | 2012-02-16 | 2013-08-22 | Teva Pharmaceutical Industries Ltd. | N-ethyl-n-phenyl-1,2-dihydro-4,5-di-hydroxy-1-methyl-2-oxo-3-quinoline carboxamide, preparation and uses thereof |
| US20130259856A1 (en) | 2012-03-27 | 2013-10-03 | Teva Pharmaceutical Industries, Ltd. | Treatment of multiple sclerosis with combination of laquinimod and dimethyl fumarate |
| TW201350467A (zh) | 2012-05-08 | 2013-12-16 | Teva Pharma | Ｎ－乙基－４－羥基－１－甲基－５－（甲基（２，３，４，５，６－五羥基己基）胺基）－２－側氧－ｎ－苯基－１，２－二氫喹啉－３－甲醯胺 |
| TW201400117A (zh) | 2012-06-05 | 2014-01-01 | Teva Pharma | 使用拉喹莫德治療眼發炎疾病 |
| AR091706A1 (es) * | 2012-07-11 | 2015-02-25 | Teva Pharma | Formulaciones de laquinimod sin agentes alcalinizantes |
| TW201410244A (zh) | 2012-08-13 | 2014-03-16 | Teva Pharma | 用於治療ｇａｂａ媒介之疾病之拉喹莫德（ｌａｑｕｉｎｉｍｏｄ） |
| CN103626701A (zh) * | 2012-08-28 | 2014-03-12 | 天津药物研究院 | 一种制备喹啉衍生物的方法 |
| CN103626702A (zh) * | 2012-08-30 | 2014-03-12 | 天津药物研究院 | 一种制备喹啉酮衍生物的方法 |
| CN104584098B (zh) | 2012-09-03 | 2017-09-15 | 丰田自动车株式会社 | 碰撞判定装置和碰撞判定方法 |
| AU2013341506A1 (en) | 2012-11-07 | 2015-06-04 | Teva Pharmaceutical Industries Ltd. | Amine salts of Laquinimod |
| JP2016513665A (ja) | 2013-03-14 | 2016-05-16 | テバ ファーマシューティカル インダストリーズ リミティド | ラキニモドの経皮製剤 |
| CA2901849A1 (en) * | 2013-03-14 | 2014-09-25 | Teva Pharmaceutical Industries Ltd. | Crystals of laquinimod sodium and improved process for the manufacture thereof |
| KR102495018B1 (ko) | 2013-11-15 | 2023-02-06 | 아케비아 테라퓨틱스 인코포레이티드 | ｛[5-(3-클로로페닐)-3-하이드록시피리딘-2-카보닐]아미노｝아세트산의 고체형, 이의 조성물 및 용도 |
| SG11201608674UA (en) | 2014-04-29 | 2016-11-29 | Teva Pharma | Laquinimod for the treatment of relapsing-remitting multiple sclerosis (rrms) patients with a high disability status |
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- 2006-10-18 BR BRPI0617477-9A patent/BRPI0617477A2/pt not_active Application Discontinuation
- 2006-10-18 AU AU2006304672A patent/AU2006304672B2/en not_active Ceased
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