BRPI0917562B8 - composição farmacêutica estabilizada contra oxidação - Google Patents
composição farmacêutica estabilizada contra oxidaçãoInfo
- Publication number
- BRPI0917562B8 BRPI0917562B8 BRPI0917562A BRPI0917562A BRPI0917562B8 BR PI0917562 B8 BRPI0917562 B8 BR PI0917562B8 BR PI0917562 A BRPI0917562 A BR PI0917562A BR PI0917562 A BRPI0917562 A BR PI0917562A BR PI0917562 B8 BRPI0917562 B8 BR PI0917562B8
- Authority
- BR
- Brazil
- Prior art keywords
- light
- clevidipine
- pharmaceutical compositions
- pharmaceutical composition
- h324ns
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 6
- 238000007254 oxidation reaction Methods 0.000 title abstract 3
- 230000003647 oxidation Effects 0.000 title abstract 2
- 238000000034 method Methods 0.000 abstract 4
- KPBZROQVTHLCDU-GOSISDBHSA-N clevidipine Chemical compound CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)[C@H]1C1=CC=CC(Cl)=C1Cl KPBZROQVTHLCDU-GOSISDBHSA-N 0.000 abstract 3
- 229960003597 clevidipine Drugs 0.000 abstract 3
- 239000004480 active ingredient Substances 0.000 abstract 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 229910052760 oxygen Inorganic materials 0.000 abstract 2
- 239000001301 oxygen Substances 0.000 abstract 2
- 230000003247 decreasing effect Effects 0.000 abstract 1
- 239000000839 emulsion Substances 0.000 abstract 1
- 230000002401 inhibitory effect Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000037361 pathway Effects 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
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
- A61K31/495—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
- 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
- A61K31/435—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
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Dispersion Chemistry (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Vascular Medicine (AREA)
- Urology & Nephrology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Hydrogenated Pyridines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
composições farmacêuticas e formulação farmacêutica para uma emulsão. 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 BRPI0917562A8 (pt) | 2017-12-12 |
| BRPI0917562B1 BRPI0917562B1 (pt) | 2021-04-06 |
| BRPI0917562B8 true 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 (22)
| 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) |
| SM (1) | SMT202000110T1 (pt) |
| WO (1) | WO2010014234A1 (pt) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011041595A1 (en) * | 2009-09-30 | 2011-04-07 | Microdose Therapeutx, Inc. | Methods and compositions for treatment of raynaud's phenomenon |
| WO2012051116A1 (en) * | 2010-10-12 | 2012-04-19 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
| US8658676B2 (en) | 2010-10-12 | 2014-02-25 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
| CA2832066C (en) * | 2011-04-01 | 2023-04-18 | The Medicines Company | Short-acting dihydropyridines (clevidipine) for use in reducing stroke damage |
| 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 |
| EA030354B1 (ru) | 2012-10-26 | 2018-07-31 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Способ уменьшения диспноэ у пациента с острой сердечной недостаточностью |
| 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 |
| CN115569120A (zh) * | 2019-08-30 | 2023-01-06 | 赫尔森保健股份公司 | 具有改善稳定性的阿拉莫林片剂的生产方法 |
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 |
| US7091216B2 (en) * | 2002-08-02 | 2006-08-15 | Merck & Co., Inc. | Substituted furo[2,3-b]pyridine derivatives |
| US20060160834A1 (en) * | 2003-06-06 | 2006-07-20 | Fong Tung M | Combination therapy for the treatment of hypertension |
| TW200613275A (en) * | 2004-08-24 | 2006-05-01 | Recordati Ireland Ltd | Lercanidipine salts |
| DE602005018387D1 (de) * | 2004-10-06 | 2010-01-28 | Eisai R&D Man Co Ltd | Medizinische zusammensetzung, verfahren zu ihrer hdihydropyridin-verbindung in einer medizinischen zusammensetzung |
| US7737155B2 (en) * | 2005-05-17 | 2010-06-15 | Schering Corporation | Nitrogen-containing heterocyclic compounds and methods of use thereof |
| EP1919285A2 (en) * | 2005-07-28 | 2008-05-14 | Reliant Pharmaceuticals, Inc. | Treatment with dihydropyridine calcium channel blockers and omega-3 fatty acids and a combination product thereof |
| WO2007121483A2 (en) * | 2006-04-18 | 2007-10-25 | Ekr Therapeutics, Inc. | Pre-mixed, ready-to-use iv bolus compositions and methods of use |
-
2009
- 2009-07-30 LT LTEP09803270.9T patent/LT2320739T/lt unknown
- 2009-07-30 EP EP09803270.9A patent/EP2320739B1/en active Active
- 2009-07-30 US US12/462,147 patent/US20100105743A1/en not_active Abandoned
- 2009-07-30 AU AU2009277100A patent/AU2009277100B2/en active Active
- 2009-07-30 MX MX2011001241A patent/MX2011001241A/es unknown
- 2009-07-30 CA CA2732692A patent/CA2732692C/en active Active
- 2009-07-30 CN CN201610773076.7A patent/CN106377501A/zh active Pending
- 2009-07-30 DK DK09803270.9T patent/DK2320739T3/da active
- 2009-07-30 WO PCT/US2009/004399 patent/WO2010014234A1/en not_active Ceased
- 2009-07-30 KR KR1020167021112A patent/KR20160095206A/ko not_active Ceased
- 2009-07-30 CN CN2009801389616A patent/CN102186351A/zh active Pending
- 2009-07-30 ES ES09803270T patent/ES2770178T3/es active Active
- 2009-07-30 PL PL09803270T patent/PL2320739T3/pl unknown
- 2009-07-30 PT PT98032709T patent/PT2320739T/pt unknown
- 2009-07-30 NZ NZ591204A patent/NZ591204A/xx unknown
- 2009-07-30 BR BRPI0917562A patent/BRPI0917562B8/pt active IP Right Grant
- 2009-07-30 HR HRP20200136TT patent/HRP20200136T1/hr unknown
- 2009-07-30 KR KR1020177012094A patent/KR20170051542A/ko not_active Ceased
- 2009-07-30 SI SI200932033T patent/SI2320739T1/sl unknown
- 2009-07-30 KR KR1020187014941A patent/KR101946977B1/ko active Active
- 2009-07-30 SM SM20200110T patent/SMT202000110T1/it unknown
- 2009-07-30 JP JP2011521123A patent/JP2011529879A/ja active Pending
- 2009-07-30 EA EA201170287A patent/EA201170287A1/ru unknown
- 2009-07-30 KR KR1020117004355A patent/KR20110059843A/ko not_active Ceased
- 2009-07-30 HU HUE09803270A patent/HUE047692T2/hu 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
-
2019
- 2019-12-20 CY CY20191101341T patent/CY1122526T1/el unknown
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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. |
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| 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 |