BRPI0917562A8 - Composição farmacêutica estabilizada contra oxidação - Google Patents
Composição farmacêutica estabilizada contra oxidaçãoInfo
- Publication number
- BRPI0917562A8 BRPI0917562A8 BRPI0917562A BRPI0917562A BRPI0917562A8 BR PI0917562 A8 BRPI0917562 A8 BR PI0917562A8 BR PI0917562 A BRPI0917562 A BR PI0917562A BR PI0917562 A BRPI0917562 A BR PI0917562A BR PI0917562 A8 BRPI0917562 A8 BR PI0917562A8
- Authority
- BR
- Brazil
- Prior art keywords
- pharmaceutical composition
- light
- clevidipine
- against oxidation
- h324ns
- Prior art date
Links
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
-
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Dispersion Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Urology & Nephrology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Hydrogenated Pyridines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
COMPOSIÇÃO FARMACÊUTICA ESTABILIZADA CONTRA OXIDAÇÃO. Composições farmacêuticas, e um método de estabilizar as composições farmacêuticas tendo clevidipina, ou qualquer sal farmaceuticamente aceitável da mesma, como o ingrediente ativo é descrito. O método inclui diminuir ou inibir a via de oxidação da clevidipina. Isto pode ser realizado reduzindo a quantidade que a composição farmacêutica é exposta ao oxigênio e/ou á luz durante os processos de fabricação e armazenamento. De acordo com este método, oxigênio deve ser removido ou substituído, ou luz deve ser suficientemente bloqueada de modo que a energia da luz não pode alcançar o ingrediente ativo da composição, ou é reduzida para um nível que a reação de oxidação induzida por luz que converte clevidipina para H324nS é minimizada, de modo que p nível detectável total de H324nS em uma amostra de composição dada não execede cerca 0 2% em uma base de peso por peso.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US8559408P | 2008-08-01 | 2008-08-01 | |
US61/085,594 | 2008-08-01 | ||
US9381008P | 2008-09-03 | 2008-09-03 | |
US61/093,810 | 2008-09-03 | ||
PCT/US2009/004399 WO2010014234A1 (en) | 2008-08-01 | 2009-07-30 | Pharmaceutical compositions and methods for stabilizing the same |
Publications (4)
Publication Number | Publication Date |
---|---|
BRPI0917562A2 BRPI0917562A2 (pt) | 2017-06-20 |
BRPI0917562A8 true BRPI0917562A8 (pt) | 2017-12-12 |
BRPI0917562B1 BRPI0917562B1 (pt) | 2021-04-06 |
BRPI0917562B8 BRPI0917562B8 (pt) | 2021-05-25 |
Family
ID=41610652
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0917562A BRPI0917562B8 (pt) | 2008-08-01 | 2009-07-30 | composição farmacêutica estabilizada contra oxidação |
Country Status (21)
Country | Link |
---|---|
US (4) | US20100105743A1 (pt) |
EP (1) | EP2320739B1 (pt) |
JP (4) | JP2011529879A (pt) |
KR (4) | KR20160095206A (pt) |
CN (2) | CN106377501A (pt) |
AU (1) | AU2009277100B2 (pt) |
BR (1) | BRPI0917562B8 (pt) |
CA (1) | CA2732692C (pt) |
CY (1) | CY1122526T1 (pt) |
DK (1) | DK2320739T3 (pt) |
EA (1) | EA201170287A1 (pt) |
ES (1) | ES2770178T3 (pt) |
HR (1) | HRP20200136T1 (pt) |
HU (1) | HUE047692T2 (pt) |
LT (1) | LT2320739T (pt) |
MX (1) | MX2011001241A (pt) |
NZ (1) | NZ591204A (pt) |
PL (1) | PL2320739T3 (pt) |
PT (1) | PT2320739T (pt) |
SI (1) | SI2320739T1 (pt) |
WO (1) | WO2010014234A1 (pt) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20110076334A1 (en) * | 2009-09-30 | 2011-03-31 | Robert Cook | Methods and compositions for treatment of raynaud's phenomenon |
US8658676B2 (en) | 2010-10-12 | 2014-02-25 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
WO2012051116A1 (en) * | 2010-10-12 | 2012-04-19 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
JP2014509654A (ja) * | 2011-04-01 | 2014-04-21 | ザ メディシンズ カンパニー | 脳卒中損傷の低減に使用するための短時間作用型ジヒドロピリジン(クレビジピン) |
CN103134891A (zh) * | 2011-11-30 | 2013-06-05 | 天津金耀集团有限公司 | 一种丁酸氯维地平含量和有关物质的测定方法 |
BR112015009291B1 (pt) | 2012-10-26 | 2021-03-16 | Chiesi Farmaceutici S.P.A | uso de clevidipina para controle da pressão arterial e redução da dispneia na insuficiência cardíaca |
CN103520104B (zh) * | 2013-10-25 | 2015-08-26 | 北京蓝丹医药科技有限公司 | 丁酸氯维地平脂肪乳注射液及其制备方法 |
CN109776405A (zh) * | 2019-03-07 | 2019-05-21 | 重庆安格龙翔医药科技有限公司 | 一种丁酸氯维地平杂质的制备方法 |
Family Cites Families (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE756779A (fr) * | 1969-09-30 | 1971-03-01 | Warner Lambert Pharmaceutical | Solutions stables de cardenolides sensibles a l'oxydation |
US4150744A (en) * | 1976-02-27 | 1979-04-24 | Smith & Nephew Pharmaceuticals Ltd. | Packaging |
DE3532129A1 (de) * | 1985-09-10 | 1987-03-12 | Bayer Ag | Ss-carotin enthaltende gelatine |
US5651991A (en) * | 1987-10-28 | 1997-07-29 | Nippon Shinyaku Co. Ltd. | Drug carriers |
AU614465B2 (en) * | 1989-04-05 | 1991-08-29 | Yissum Research Development Company Of The Hebrew University Of Jerusalem | Medicinal emulsions |
SE9303744D0 (sv) | 1993-11-12 | 1993-11-12 | Astra Ab | Pharmaceutical emulsion |
SE9804002D0 (sv) | 1998-11-23 | 1998-11-23 | Astra Ab | New manufacturing process |
JP2000247883A (ja) * | 1999-02-23 | 2000-09-12 | Fujisawa Pharmaceut Co Ltd | ジヒドロピリジン系化合物を含有する内服用液剤 |
US20030102246A1 (en) * | 1999-03-20 | 2003-06-05 | Lts Lohmann Therapie-Systeme Ag | Method for improving the stability of stored and/or used light-sensitive therapeutic systems or components thereof |
US6956048B2 (en) * | 1999-03-31 | 2005-10-18 | Pharmacia & Upjohn Company | Pharmaceutical emulsions for retroviral protease inhibitors |
US6680334B2 (en) * | 2001-08-28 | 2004-01-20 | Pfizer Inc | Crystalline material |
JP2003104888A (ja) * | 2001-09-28 | 2003-04-09 | Taiyo Yakuhin Kogyo Kk | ジヒドロピリジン誘導体の錠剤 |
DE10224612A1 (de) * | 2002-06-04 | 2003-12-24 | Lohmann Therapie Syst Lts | Wirkstoffhaltige filmförmige Zubereitungen mit verbesserter chemischer Stabilität, und Verfahren zu deren Herstellung |
JP4667867B2 (ja) * | 2002-08-02 | 2011-04-13 | メルク・シャープ・エンド・ドーム・コーポレイション | 置換フロ[2,3−b]ピリジン誘導体 |
WO2004110368A2 (en) * | 2003-06-06 | 2004-12-23 | Merck & Co., Inc. | Combination therapy for the treatment of hypertension |
TW200613275A (en) * | 2004-08-24 | 2006-05-01 | Recordati Ireland Ltd | Lercanidipine salts |
EP1813274B1 (en) * | 2004-10-06 | 2009-12-16 | Eisai R&D Management Co., Ltd. | Medicinal composition, process for producing the same, and method of stabilizing dihydropyridine compound in medicinal composition |
US7737155B2 (en) * | 2005-05-17 | 2010-06-15 | Schering Corporation | Nitrogen-containing heterocyclic compounds and methods of use thereof |
US20070196465A1 (en) * | 2005-07-28 | 2007-08-23 | George Bobotas | Treatment with dihydropyridine calcium channel blockers and omega-3 fatty acids and a combination product thereof |
US7612102B2 (en) * | 2006-04-18 | 2009-11-03 | Ekr Therapeutics, Inc. | Pre-mixed, ready-to-use pharmaceutical compositions |
-
2009
- 2009-07-30 KR KR1020167021112A patent/KR20160095206A/ko active Application Filing
- 2009-07-30 KR KR1020117004355A patent/KR20110059843A/ko active Application Filing
- 2009-07-30 CN CN201610773076.7A patent/CN106377501A/zh active Pending
- 2009-07-30 HU HUE09803270A patent/HUE047692T2/hu unknown
- 2009-07-30 KR KR1020187014941A patent/KR101946977B1/ko active IP Right Grant
- 2009-07-30 EA EA201170287A patent/EA201170287A1/ru unknown
- 2009-07-30 MX MX2011001241A patent/MX2011001241A/es unknown
- 2009-07-30 PL PL09803270T patent/PL2320739T3/pl unknown
- 2009-07-30 CA CA2732692A patent/CA2732692C/en active Active
- 2009-07-30 CN CN2009801389616A patent/CN102186351A/zh active Pending
- 2009-07-30 PT PT98032709T patent/PT2320739T/pt unknown
- 2009-07-30 US US12/462,147 patent/US20100105743A1/en not_active Abandoned
- 2009-07-30 JP JP2011521123A patent/JP2011529879A/ja active Pending
- 2009-07-30 BR BRPI0917562A patent/BRPI0917562B8/pt active IP Right Grant
- 2009-07-30 EP EP09803270.9A patent/EP2320739B1/en active Active
- 2009-07-30 DK DK09803270.9T patent/DK2320739T3/da active
- 2009-07-30 NZ NZ591204A patent/NZ591204A/xx unknown
- 2009-07-30 WO PCT/US2009/004399 patent/WO2010014234A1/en active Application Filing
- 2009-07-30 ES ES09803270T patent/ES2770178T3/es active Active
- 2009-07-30 AU AU2009277100A patent/AU2009277100B2/en active Active
- 2009-07-30 KR KR1020177012094A patent/KR20170051542A/ko active Application Filing
- 2009-07-30 LT LTEP09803270.9T patent/LT2320739T/lt unknown
- 2009-07-30 SI SI200932033T patent/SI2320739T1/sl unknown
-
2012
- 2012-08-30 US US13/600,083 patent/US20120322836A1/en not_active Abandoned
-
2015
- 2015-01-23 JP JP2015010907A patent/JP2015098472A/ja not_active Withdrawn
-
2016
- 2016-08-29 JP JP2016166426A patent/JP2016216501A/ja active Pending
-
2017
- 2017-01-11 JP JP2017002785A patent/JP6537538B2/ja active Active
-
2018
- 2018-12-21 US US16/229,654 patent/US20190117660A1/en not_active Abandoned
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2019
- 2019-12-20 CY CY20191101341T patent/CY1122526T1/el unknown
-
2020
- 2020-01-29 HR HRP20200136TT patent/HRP20200136T1/hr unknown
-
2023
- 2023-05-30 US US18/203,381 patent/US20230302002A1/en active Pending
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
B25A | Requested transfer of rights approved |
Owner name: CHIESI FARMACEUTICI S.P.A. (IT) |
|
B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
B06T | Formal requirements before examination [chapter 6.20 patent gazette] | ||
B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
B09X | Republication of the decision to grant [chapter 9.1.3 patent gazette] | ||
B09X | Republication of the decision to grant [chapter 9.1.3 patent gazette] | ||
B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 06/04/2021, OBSERVADAS AS CONDICOES LEGAIS. |
|
B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/07/2009 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |