BRPI0917562A8 - Composição farmacêutica estabilizada contra oxidação - Google Patents

Composição farmacêutica estabilizada contra oxidação

Info

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
Application number
BRPI0917562A
Other languages
English (en)
Inventor
Motheram Rajeshwar
Krishna Gopal
Ding Min
Original Assignee
The Medicines Co
Chiesi Farm Spa
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 The Medicines Co, Chiesi Farm Spa filed Critical The Medicines Co
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
    • A61K31/435—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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Urology & Nephrology (AREA)
  • Neurology (AREA)
  • Neurosurgery (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.
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 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) 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)
WO (1) WO2010014234A1 (pt)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120100945A (ko) * 2009-09-30 2012-09-12 마이크로도스 테라퓨특스, 인코포레이티드 레이노 증후군의 치료를 위한 방법들 및 조성물들
HUE026295T2 (en) 2010-10-12 2016-06-28 The Medicines Co Clevidipine emulsion formulations containing antimicrobial agents
US8658676B2 (en) 2010-10-12 2014-02-25 The Medicines Company Clevidipine emulsion formulations containing antimicrobial agents
BR112013025368A8 (pt) * 2011-04-01 2018-06-12 The Medicines Co Medicamento, método para preparar um medicamento útil para reduzir danos por derrame em um sujeito com derrame, método para preparar um medicamento útil para reduzir a pressão sanguínea e reduzir danos por derrame em um sujeito com derrame
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

Family Cites Families (20)

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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
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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
ES2294330T3 (es) * 2002-08-02 2008-04-01 MERCK & CO., INC. Derivados de furo(2,3-b)piridina sustituidos.
EP1635773A2 (en) * 2003-06-06 2006-03-22 Merck & Co., Inc. (a New Jersey corp.) Combination therapy for the treatment of hypertension
TW200613275A (en) * 2004-08-24 2006-05-01 Recordati Ireland Ltd Lercanidipine salts
JP4509118B2 (ja) * 2004-10-06 2010-07-21 エルメッド エーザイ株式会社 医薬組成物及びその製造方法、並びに医薬組成物におけるジヒドロピリジン系化合物の安定化方法
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BRPI0614417A2 (pt) * 2005-07-28 2011-03-29 Reliant Pharmaceuticals Inc composições farmacêuticas compreendendo bloqueadores de canais de cálcio de dihidropiridina e ácidos graxos de Èmega-3 e métodos de tratamento utilizando as mesmas
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Also Published As

Publication number Publication date
CA2732692C (en) 2019-12-24
KR20170051542A (ko) 2017-05-11
SI2320739T1 (sl) 2020-03-31
ES2770178T3 (es) 2020-06-30
KR20160095206A (ko) 2016-08-10
JP2016216501A (ja) 2016-12-22
DK2320739T3 (da) 2020-02-24
CA2732692A1 (en) 2010-02-04
JP2015098472A (ja) 2015-05-28
EA201170287A1 (ru) 2011-10-31
HUE047692T2 (hu) 2020-05-28
JP2011529879A (ja) 2011-12-15
HRP20200136T1 (hr) 2020-08-21
BRPI0917562B8 (pt) 2021-05-25
EP2320739B1 (en) 2019-11-27
NZ591204A (en) 2013-02-22
US20100105743A1 (en) 2010-04-29
PL2320739T3 (pl) 2020-06-01
KR20180059956A (ko) 2018-06-05
CY1122526T1 (el) 2021-01-27
KR101946977B1 (ko) 2019-05-21
JP6537538B2 (ja) 2019-07-03
AU2009277100A1 (en) 2010-02-04
CN102186351A (zh) 2011-09-14
US20190117660A1 (en) 2019-04-25
LT2320739T (lt) 2020-01-27
MX2011001241A (es) 2011-08-03
US20230302002A1 (en) 2023-09-28
BRPI0917562A2 (pt) 2017-06-20
PT2320739T (pt) 2020-02-18
US20120322836A1 (en) 2012-12-20
JP2017081980A (ja) 2017-05-18
EP2320739A4 (en) 2011-08-24
CN106377501A (zh) 2017-02-08
BRPI0917562B1 (pt) 2021-04-06
AU2009277100B2 (en) 2015-05-28
KR20110059843A (ko) 2011-06-07
WO2010014234A1 (en) 2010-02-04
EP2320739A1 (en) 2011-05-18

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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