MX2015011627A - Cristales de laquinimod sodico y proceso mejorado para la elaboracion de los mismos. - Google Patents
Cristales de laquinimod sodico y proceso mejorado para la elaboracion de los mismos.Info
- Publication number
- MX2015011627A MX2015011627A MX2015011627A MX2015011627A MX2015011627A MX 2015011627 A MX2015011627 A MX 2015011627A MX 2015011627 A MX2015011627 A MX 2015011627A MX 2015011627 A MX2015011627 A MX 2015011627A MX 2015011627 A MX2015011627 A MX 2015011627A
- Authority
- MX
- Mexico
- Prior art keywords
- laquinimod
- hlaq
- pharmaceutical composition
- mcqee
- mcqme
- Prior art date
Links
Classifications
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- 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
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C235/00—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms
- C07C235/02—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton
- C07C235/04—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton the carbon skeleton being acyclic and saturated
- C07C235/16—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by oxygen atoms having carbon atoms of carboxamide groups bound to acyclic carbon atoms and singly-bound oxygen atoms bound to the same carbon skeleton the carbon skeleton being acyclic and saturated having the nitrogen atom of at least one of the carboxamide groups bound to a carbon atom of a six-membered aromatic ring
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
-
- 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
Abstract
La invención objetivo proporciona una mezcla de partículas de laquinimod sódico cristalinas, en donde (i) = 90% de la cantidad total en volumen de las partículas de laquinimod sódico tienen un tamaño de = 40 µm o (ii) = 50% de la cantidad total en volumen de las partículas de laquinimod sódico que tienen un tamaño de = 15 µm, y en donde: a) la mezcla tiene una densidad evidente de 0.2-0.4 g/mL; b) la mezcla tiene una densidad compactada de 0.40-0.7 g/mL; c) una cantidad de metal pesado en la mezcla no es más que 20 ppm con respecto a la cantidad en peso de laquinimod sádico; d) una cantidad de MCQ en la mezcla no es más que 0.15% con respecto a la cantidad de laquinimod sádico de acuerdo con HPLC; e)una cantidad de MCQCA en la mezcla no es más que 0.15% con respecto a la cantidad de laquinimod sádico de acuerdo con HPLC; o f) una cantidad de MCQME en la mezcla no es más que 0.12% con respecto a la cantidad de laquinimod sádico de acuerdo con HPLC. La invención objetivo también proporciona una composición farmacéutica que comprende una cantidad de laquinimod y al menos uno de BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, y MCQEE. La invención objetivo también proporciona procesos para preparar BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, y compuestos preparados por los procesos. Además se proporciona un proceso para probar si una muestra de laquinimod contiene una impureza indeseable. Se proporciona además un proceso para preparar una composición farmacéutica validada que comprende laquinimod, para preparar una composición farmacéutica que comprende laquinimod, o para distribuir un lote validado de una composición farmacéutica que comprende laquinimod, para validad un lote de un producto farmacéutico que contiene laquinimod y un portador farmacéuticamente aceptable para distribución, y para preparar una composición farmacéutica empacada que comprende laquinimod, cada uno que comprende determinar la cantidad de al menos uno de BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, y MCQEE en una muestra o lote. La invención objetivo proporciona además el uso de BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE como un estándar de referencia para detectar tal cantidades trazas de la impureza en una composición farmacéutica que comprende laquinimod. Finalmente, la invención objetivo proporciona métodos para determinar la concentración de BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, 5-HLAQ, SPIRO-LAQ o 3 H-LAQ en una composición farmacéutica que comprende laquinimod.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361785575P | 2013-03-14 | 2013-03-14 | |
PCT/US2014/029292 WO2014153145A2 (en) | 2013-03-14 | 2014-03-14 | Crystals of laquinimod sodium and improved process for the manufacture thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2015011627A true MX2015011627A (es) | 2016-05-16 |
Family
ID=50631081
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2015011627A MX2015011627A (es) | 2013-03-14 | 2014-03-14 | Cristales de laquinimod sodico y proceso mejorado para la elaboracion de los mismos. |
Country Status (19)
Country | Link |
---|---|
US (4) | US9233927B2 (es) |
EP (1) | EP2970129A2 (es) |
JP (1) | JP2016514162A (es) |
KR (1) | KR20150143499A (es) |
CN (1) | CN105051013A (es) |
AR (1) | AR095562A1 (es) |
AU (1) | AU2014236232A1 (es) |
BR (1) | BR112015021602A2 (es) |
CA (1) | CA2901849A1 (es) |
CL (1) | CL2015002712A1 (es) |
EA (1) | EA201591699A1 (es) |
HK (2) | HK1216311A1 (es) |
IL (1) | IL240356A0 (es) |
MX (1) | MX2015011627A (es) |
NZ (1) | NZ630427A (es) |
PE (1) | PE20151935A1 (es) |
SG (1) | SG11201506409RA (es) |
TW (1) | TW201519892A (es) |
WO (1) | WO2014153145A2 (es) |
Families Citing this family (7)
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CN102781239B (zh) * | 2010-03-03 | 2015-01-21 | 泰华制药工业有限公司 | 使用拉喹莫德治疗狼疮关节炎 |
BR112014018485A8 (pt) | 2012-02-03 | 2017-07-11 | Teva Pharma | Uso de laquinimod para tratar pacientes com a doença de crohn que falharam com a primeira linha de terapia anti-tnf |
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) |
SG11201506409RA (en) * | 2013-03-14 | 2015-09-29 | Teva Pharma | Crystals of laquinimod sodium and improved process for the manufacture thereof |
CN106573014A (zh) | 2014-04-29 | 2017-04-19 | 梯瓦制药工业有限公司 | 用于治疗具有高残疾状况的复发‑缓解型多发性硬化症(rrms)的患者的拉喹莫德 |
CN107966506B (zh) * | 2017-11-20 | 2019-09-13 | 福州大学 | 一种橡胶及橡胶制品中n-乙基苯胺含量的检测方法 |
KR102069868B1 (ko) * | 2018-02-28 | 2020-01-23 | 고려대학교 산학협력단 | 합성가스 발효 균의 합성가스 발효 시의 대사체 분석을 위한 대사체 샘플링 및 분석 방법 |
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WO2014004733A1 (en) | 2012-06-26 | 2014-01-03 | The Regents Of The University Of California | Composition for lupus nephritis and methods of making and using the same |
AR091706A1 (es) | 2012-07-11 | 2015-02-25 | Teva Pharma | Formulaciones de laquinimod sin agentes alcalinizantes |
UY34896A (es) | 2012-07-12 | 2014-02-28 | Teva Pharma | Tratamiento de la esclerosis múltiple con una combinación de laquinimod y fampridina |
TW201410243A (zh) | 2012-08-13 | 2014-03-16 | Teva Pharma | 用於治療***素受體型1(cb1)媒介之疾病之拉喹莫德(laquinimod) |
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) |
SG11201506409RA (en) * | 2013-03-14 | 2015-09-29 | Teva Pharma | Crystals of laquinimod sodium and improved process for the manufacture thereof |
-
2014
- 2014-03-14 SG SG11201506409RA patent/SG11201506409RA/en unknown
- 2014-03-14 EP EP14721137.9A patent/EP2970129A2/en not_active Withdrawn
- 2014-03-14 EA EA201591699A patent/EA201591699A1/ru unknown
- 2014-03-14 BR BR112015021602A patent/BR112015021602A2/pt not_active IP Right Cessation
- 2014-03-14 PE PE2015001974A patent/PE20151935A1/es not_active Application Discontinuation
- 2014-03-14 CA CA2901849A patent/CA2901849A1/en not_active Abandoned
- 2014-03-14 US US14/214,191 patent/US9233927B2/en not_active Expired - Fee Related
- 2014-03-14 AU AU2014236232A patent/AU2014236232A1/en not_active Abandoned
- 2014-03-14 WO PCT/US2014/029292 patent/WO2014153145A2/en active Application Filing
- 2014-03-14 TW TW103109454A patent/TW201519892A/zh unknown
- 2014-03-14 CN CN201480014512.1A patent/CN105051013A/zh active Pending
- 2014-03-14 JP JP2016503050A patent/JP2016514162A/ja not_active Withdrawn
- 2014-03-14 US US14/773,683 patent/US20160046582A1/en not_active Abandoned
- 2014-03-14 KR KR1020157029570A patent/KR20150143499A/ko not_active Application Discontinuation
- 2014-03-14 NZ NZ630427A patent/NZ630427A/en not_active IP Right Cessation
- 2014-03-14 MX MX2015011627A patent/MX2015011627A/es unknown
- 2014-03-17 AR ARP140101184A patent/AR095562A1/es unknown
-
2015
- 2015-08-04 IL IL240356A patent/IL240356A0/en unknown
- 2015-09-14 CL CL2015002712A patent/CL2015002712A1/es unknown
- 2015-12-03 US US14/958,396 patent/US20160158216A1/en not_active Abandoned
-
2016
- 2016-04-11 HK HK16104113.6A patent/HK1216311A1/zh unknown
- 2016-06-22 HK HK16107245.0A patent/HK1220444A1/zh unknown
-
2017
- 2017-08-01 US US15/666,259 patent/US20170327464A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
WO2014153145A3 (en) | 2015-04-23 |
BR112015021602A2 (pt) | 2017-07-18 |
EA201591699A1 (ru) | 2016-02-29 |
HK1220444A1 (zh) | 2017-05-05 |
SG11201506409RA (en) | 2015-09-29 |
CA2901849A1 (en) | 2014-09-25 |
CL2015002712A1 (es) | 2016-04-15 |
US9233927B2 (en) | 2016-01-12 |
PE20151935A1 (es) | 2016-01-15 |
US20160158216A1 (en) | 2016-06-09 |
TW201519892A (zh) | 2015-06-01 |
WO2014153145A2 (en) | 2014-09-25 |
AU2014236232A1 (en) | 2015-11-05 |
HK1216311A1 (zh) | 2016-11-04 |
NZ630427A (en) | 2017-06-30 |
JP2016514162A (ja) | 2016-05-19 |
KR20150143499A (ko) | 2015-12-23 |
US20170327464A1 (en) | 2017-11-16 |
US20140271878A1 (en) | 2014-09-18 |
EP2970129A2 (en) | 2016-01-20 |
CN105051013A (zh) | 2015-11-11 |
IL240356A0 (en) | 2015-09-24 |
AR095562A1 (es) | 2015-10-28 |
US20160046582A1 (en) | 2016-02-18 |
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