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DK2320740T3 - Farmaceutiske sammensætninger af clevidipin og fremgangsmåder tilfremstilling af koncentrationer deraf med lave urenhedsgrader - Google Patents

Farmaceutiske sammensætninger af clevidipin og fremgangsmåder tilfremstilling af koncentrationer deraf med lave urenhedsgrader

Info

Publication number
DK2320740T3
DK2320740T3 DK09803550.4T DK09803550T DK2320740T3 DK 2320740 T3 DK2320740 T3 DK 2320740T3 DK 09803550 T DK09803550 T DK 09803550T DK 2320740 T3 DK2320740 T3 DK 2320740T3
Authority
DK
Denmark
Prior art keywords
clevidipin
concentrations
preparing
methods
pharmaceutical compositions
Prior art date
Application number
DK09803550.4T
Other languages
English (en)
Inventor
Kornepati Ramakrishna
Keith Flood
Rajeshwar Motheram
Gopal Krishna
Min Ding
Original Assignee
Hospira Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41610719&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2320740(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hospira Inc, Medicines Co filed Critical Hospira Inc
Application granted granted Critical
Publication of DK2320740T3 publication Critical patent/DK2320740T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/4353Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
DK09803550.4T 2008-08-01 2009-07-29 Farmaceutiske sammensætninger af clevidipin og fremgangsmåder tilfremstilling af koncentrationer deraf med lave urenhedsgrader DK2320740T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US8559708P 2008-08-01 2008-08-01
US9377208P 2008-09-03 2008-09-03
PCT/US2009/052127 WO2010014727A1 (en) 2008-08-01 2009-07-29 Pharmaceutical compositions and methods for producing low impurity concentrations of the same

Publications (1)

Publication Number Publication Date
DK2320740T3 true DK2320740T3 (da) 2014-06-30

Family

ID=41610719

Family Applications (1)

Application Number Title Priority Date Filing Date
DK09803550.4T DK2320740T3 (da) 2008-08-01 2009-07-29 Farmaceutiske sammensætninger af clevidipin og fremgangsmåder tilfremstilling af koncentrationer deraf med lave urenhedsgrader

Country Status (20)

Country Link
US (6) US20100113534A1 (da)
EP (2) EP2320740B1 (da)
JP (1) JP5674660B2 (da)
KR (1) KR101772602B1 (da)
CN (1) CN102170786B (da)
AU (1) AU2009276560B2 (da)
BR (1) BRPI0916936B8 (da)
CA (2) CA3108961C (da)
CY (1) CY1116490T1 (da)
DK (1) DK2320740T3 (da)
EA (1) EA021336B1 (da)
ES (1) ES2468837T3 (da)
HR (1) HRP20140434T1 (da)
MX (1) MX2011001240A (da)
NZ (1) NZ591205A (da)
PL (1) PL2320740T3 (da)
PT (1) PT2320740E (da)
SI (1) SI2320740T1 (da)
SM (1) SMT201400081B (da)
WO (1) WO2010014727A1 (da)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101772602B1 (ko) 2008-08-01 2017-08-29 치에시 파마슈티시 에스.피.아. 약제학적 조성물 및 그의 저 불순물 농축물을 제조하는 방법
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
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
WO2014066870A1 (en) 2012-10-26 2014-05-01 The Medicines Company Methods for controlling blood pressure and reducing dyspnea in heart failure
CN103417539B (zh) * 2013-08-22 2015-11-25 北京蓝丹医药科技有限公司 一种丁酸氯维地平药物组合物
CN104974042A (zh) * 2014-04-09 2015-10-14 上海信谊金朱药业有限公司 化合物的制备方法
CN104974043A (zh) * 2014-04-09 2015-10-14 上海信谊金朱药业有限公司 丁酸氯维地平的杂质化合物的制备方法
KR102380701B1 (ko) * 2014-05-19 2022-03-31 치에시 파마슈티시 에스.피.아. 클레비디핀 나노입자 및 그의 제약적 조성물
CN104458937B (zh) * 2014-11-20 2017-02-22 北京京科泰来科技有限公司 一种丁酸氯维地平脂肪乳有关物质检测方法
CN104597192B (zh) * 2014-12-31 2016-08-24 武汉科福新药有限责任公司 一种丁酸氯维地平及其制剂中有关物质的检测方法
CN105853353A (zh) * 2015-01-20 2016-08-17 江苏正大丰海制药有限公司 一种氯维地平脂肪乳注射液的制备方法
CN107362139B (zh) * 2017-08-29 2020-11-03 辅必成(上海)医药科技有限公司 一种丁酸氯维地平的乳剂注射液
US20200316043A1 (en) * 2017-12-20 2020-10-08 Aurobindo Pharma Ltd. Pharmaceutical composition comprising clevidipine and process for preparation thereof
CN109956943B (zh) * 2019-04-18 2021-07-20 合肥合源药业有限公司 一种二氢吡啶类药物中脱羧缩合杂质及其制备、控制方法

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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
SE9303657D0 (sv) * 1993-11-05 1993-11-05 Astra Ab Short-acting dihydropyridines
SE9303744D0 (sv) 1993-11-12 1993-11-12 Astra Ab Pharmaceutical emulsion
GB9405593D0 (en) 1994-03-22 1994-05-11 Zeneca Ltd Pharmaceutical compositions
SE9804002D0 (sv) * 1998-11-23 1998-11-23 Astra Ab New manufacturing process
AU3883700A (en) 1999-03-31 2000-10-16 Pharmacia & Upjohn Company Pharmaceutical emulsions for retroviral protease inhibitors
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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
CA2494091C (en) * 2002-08-02 2011-02-01 Richard B. Toupence Substituted furo [2,3-b| pyridine derivatives
WO2004110368A2 (en) * 2003-06-06 2004-12-23 Merck & Co., Inc. Combination therapy for the treatment of hypertension
US20050186230A1 (en) 2004-01-23 2005-08-25 Sd Pharmaceuticals, Inc. Elemene compositions containing liquid oil
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
US20100016378A1 (en) * 2005-04-28 2010-01-21 Toshio Suzuki Method of preventing dihydropyridine compound from degradation
US7737155B2 (en) * 2005-05-17 2010-06-15 Schering Corporation Nitrogen-containing heterocyclic compounds and methods of use thereof
CA2616806A1 (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
KR101772602B1 (ko) 2008-08-01 2017-08-29 치에시 파마슈티시 에스.피.아. 약제학적 조성물 및 그의 저 불순물 농축물을 제조하는 방법
US8501727B2 (en) 2008-08-22 2013-08-06 Milestone Pharmaceuticals Inc. Short acting benzothiazepine calcium channel blockers and uses thereof
CN101766568A (zh) 2008-12-31 2010-07-07 北京利乐生制药科技有限公司 一种含有氯维地平的乳剂及其制备工艺和用途
CN101780036B (zh) 2010-03-30 2011-11-16 武汉武药科技有限公司 丁酸氯维地平脂微球注射液及其制备方法
US8658676B2 (en) 2010-10-12 2014-02-25 The Medicines Company Clevidipine emulsion formulations containing antimicrobial agents
HUE026295T2 (en) 2010-10-12 2016-06-28 The Medicines Co Clevidipine emulsion formulations containing antimicrobial agents

Also Published As

Publication number Publication date
CA2732760A1 (en) 2010-02-04
KR101772602B1 (ko) 2017-08-29
MX2011001240A (es) 2011-08-12
EA021336B1 (ru) 2015-05-29
PL2320740T3 (pl) 2014-09-30
US20140005233A1 (en) 2014-01-02
US20190091212A1 (en) 2019-03-28
AU2009276560A1 (en) 2010-02-04
US20100113534A1 (en) 2010-05-06
BRPI0916936A2 (pt) 2017-05-23
ES2468837T3 (es) 2014-06-17
WO2010014727A1 (en) 2010-02-04
EP2320740A1 (en) 2011-05-18
CN102170786A (zh) 2011-08-31
US20220000849A1 (en) 2022-01-06
CN102170786B (zh) 2015-05-27
BRPI0916936B1 (pt) 2020-08-04
AU2009276560B2 (en) 2015-04-16
BRPI0916936A8 (pt) 2017-12-05
EA201170289A1 (ru) 2011-10-31
JP5674660B2 (ja) 2015-02-25
BRPI0916936B8 (pt) 2021-05-25
SMT201400081B (it) 2014-09-08
SI2320740T1 (sl) 2014-08-29
HRP20140434T1 (hr) 2014-08-01
EP2320740B1 (en) 2014-03-26
KR20110060889A (ko) 2011-06-08
CA3108961A1 (en) 2010-02-04
EP2320740A4 (en) 2011-11-30
US20250213540A1 (en) 2025-07-03
JP2011529900A (ja) 2011-12-15
EP2719386A1 (en) 2014-04-16
CA3108961C (en) 2024-07-02
PT2320740E (pt) 2014-06-12
US11058672B2 (en) 2021-07-13
NZ591205A (en) 2012-11-30
US20120322835A1 (en) 2012-12-20
CY1116490T1 (el) 2017-03-15

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