BRPI0917562B8 - composição farmacêutica estabilizada contra oxidação - Google Patents

composição farmacêutica estabilizada contra oxidação

Info

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
Application number
BRPI0917562A
Other languages
English (en)
Inventor
Krishna Gopal
Ding Min
Motheram Rajeshwar
Original Assignee
Chiesi Farm Spa
The Medicines Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Chiesi Farm Spa, The Medicines Co filed Critical Chiesi Farm Spa
Publication of BRPI0917562A2 publication Critical patent/BRPI0917562A2/pt
Publication of BRPI0917562A8 publication Critical patent/BRPI0917562A8/pt
Publication of BRPI0917562B1 publication Critical patent/BRPI0917562B1/pt
Publication of BRPI0917562B8 publication Critical patent/BRPI0917562B8/pt

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
    • A61K31/495—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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Hydrogenated Pyridines (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.
BRPI0917562A 2008-08-01 2009-07-30 composição farmacêutica estabilizada contra oxidação BRPI0917562B8 (pt)

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) CN102186351A (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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101644286B1 (ko) * 2009-09-30 2016-08-10 마이크로도스 테라퓨특스, 인코포레이티드 레이노 증후군의 치료를 위한 방법들 및 조성물들
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
RU2623039C2 (ru) * 2011-04-01 2017-06-21 КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. Дигидропиридины (клевидипин) кратковременного действия для применения в восстановлении после инсульта
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
CN110840890A (zh) 2012-10-26 2020-02-28 凯西制药公司 用于在心力衰竭中控制血压和减轻呼吸困难的方法
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
JP7854809B2 (ja) * 2019-08-30 2026-05-07 ヘルシン ヘルスケア ソシエテ アノニム 安定性が改善されたアナモレリン錠剤の製造方法

Family Cites Families (20)

* Cited by examiner, † Cited by third party
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
CA2013755C (en) * 1989-04-05 1993-11-30 Simon Benita 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
ATE375349T1 (de) * 2002-08-02 2007-10-15 Merck & Co Inc Substituierte furo(2,3-b)pyridin derivate
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
US20080095841A1 (en) * 2004-10-06 2008-04-24 Eisai R&D Management Co., Ltd. Pharmaceutical Composition, Method for Producing the Same, and Method for Stabilizing Dihydropyridine Compound in the Pharmaceutical Composition
US7737155B2 (en) * 2005-05-17 2010-06-15 Schering Corporation Nitrogen-containing heterocyclic compounds and methods of use thereof
AU2006275784A1 (en) * 2005-07-28 2007-02-08 Reliant Pharmaceuticals, Inc. Treatment with dihydropyridine calcium channel blockers and omega-3 fatty acids and a combination product thereof
NZ572226A (en) * 2006-04-18 2011-05-27 Ekr Therapeutics Inc Pre-mixed, ready-to-use IV bolus compositions comprising nicardipine and methods of use

Also Published As

Publication number Publication date
JP2016216501A (ja) 2016-12-22
LT2320739T (lt) 2020-01-27
KR20160095206A (ko) 2016-08-10
AU2009277100B2 (en) 2015-05-28
CY1122526T1 (el) 2021-01-27
CN102186351A (zh) 2011-09-14
JP2017081980A (ja) 2017-05-18
WO2010014234A1 (en) 2010-02-04
JP2015098472A (ja) 2015-05-28
BRPI0917562A8 (pt) 2017-12-12
CA2732692A1 (en) 2010-02-04
HRP20200136T1 (hr) 2020-08-21
EA201170287A1 (ru) 2011-10-31
BRPI0917562B1 (pt) 2021-04-06
DK2320739T3 (da) 2020-02-24
EP2320739B1 (en) 2019-11-27
MX2011001241A (es) 2011-08-03
EP2320739A4 (en) 2011-08-24
US20230302002A1 (en) 2023-09-28
JP6537538B2 (ja) 2019-07-03
SMT202000110T1 (it) 2020-03-13
US20190117660A1 (en) 2019-04-25
HUE047692T2 (hu) 2020-05-28
PT2320739T (pt) 2020-02-18
NZ591204A (en) 2013-02-22
US20100105743A1 (en) 2010-04-29
ES2770178T3 (es) 2020-06-30
SI2320739T1 (sl) 2020-03-31
KR20180059956A (ko) 2018-06-05
KR20170051542A (ko) 2017-05-11
BRPI0917562A2 (pt) 2017-06-20
EP2320739A1 (en) 2011-05-18
AU2009277100A1 (en) 2010-02-04
PL2320739T3 (pl) 2020-06-01
KR20110059843A (ko) 2011-06-07
CN106377501A (zh) 2017-02-08
US20120322836A1 (en) 2012-12-20
CA2732692C (en) 2019-12-24
JP2011529879A (ja) 2011-12-15
KR101946977B1 (ko) 2019-05-21

Similar Documents

Publication Publication Date Title
BRPI0917562A8 (pt) Composição farmacêutica estabilizada contra oxidação
Martínez‐Klimova et al. Mitochondrial dysfunction and endoplasmic reticulum stress in the promotion of fibrosis in obstructive nephropathy induced by unilateral ureteral obstruction
Bos et al. Hydrogen sulfide: physiological properties and therapeutic potential in ischaemia
Cao et al. The role of hydrogen sulfide in renal system
Elsheikh et al. Enhanced chemopreventive effects of a hydrogen sulfide-releasing anti-inflammatory drug (ATB-346) in experimental colorectal cancer
BR0016555A (pt) Composições farmacêuticas que proporcionam concentrações acrescidas de droga
BRPI0514221A (pt) composição fungicida contendo derivado de amida de ácido
UY32644A (es) Compuesto anticancerígeno y composición farmacéutica que lo contiene
BRPI0706676B8 (pt) uso de uma solução aquosa com potencial de oxirredução
BRPI0912842A8 (pt) composição farmacêutica, métodos para prevenir ou tratar o rubor induzido por niacina em um indivíduo, para reduzir pelo menos um sintoma de rubor relacionado com a terapia com niacina em um indivíduo, para diminuir os efeitos colaterais relacionados com a protaglandina em um indivíduo, para diminuir uma taxa de descontinuação do tratamento com niacina por um indivíduo, para aumentar a submissão do paciente ao tratamento com niacina, para tratar aterosclerose em um paciente, para tratar uma doença relacionada com um perfil de hdl baixo em um paciente, formulação do ácido nicotínico de dispensação modificada, uso da composição farmacêutica, e, microcápsula de aspirina
Fink et al. Effect of mitoquinone (Mito-Q) on neuropathic endpoints in an obese and type 2 diabetic rat model
SI2554183T1 (en) A pharmaceutical composition comprising the GLP-1 agonist and insulin and methionine
BR0314943A (pt) Inibidores da proteìna reguladora da condutância transmembrana da fibrose cìstica e usos destes
DK2207770T3 (da) 1, 2, 3-triazolderivater til anvendelse som stearoyl-coa desaturase-inhibitorer
AR036248A1 (es) Derivados de 2h-piridazin-3-ona, composiciones farmaceuticas que los contienen y un proceso para la preparacion de dichos derivados y el uso de dichos derivados para la preparacion de una composicion farmaceutica
Frosini et al. Selective ozone concentrations may reduce the ischemic damage after a stroke
IL251413B2 (en) Composition of injectable buprenorphine
Okamoto et al. Protective effect of hydrogen sulfide on pancreatic beta-cells
Plecitá-Hlavatá et al. Pro-oxidant mitochondrial matrix-targeted ubiquinone MitoQ10 acts as anti-oxidant at retarded electron transport or proton pumping within Complex I
Yu et al. Prodrugs of persulfide and sulfide: is there a pharmacological difference between the two in the context of rapid exchanges among various sulfur species in vivo?
MX2021014561A (es) Uso de una composicion de albumina con o sin agentes pro-emt y anti-emt (agentes para prevenir o minimizar la transicion epitelio mesenquima emt), para el tratamiento de enfermedades o afecciones de hemorragias, quemaduras, disfuncion hepatica, cancer, etc.
Ornelas et al. Mimicry of microbially-derived butyrate reveals templates for potent intestinal epithelial HIF stabilizers
Hucks et al. Homocysteine induced impairment of nitric oxide-dependent vasorelaxation is reversible by the superoxide dismutase mimetic TEMPOL
Nishima et al. Suppressing succinate accumulation during ischemia protects the kidney from IRI
Schalinske Interrelationship between diabetes and homocysteine metabolism: hormonal regulation of cystathionine [beta]-synthase

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