PL2320740T3 - Kompozycje farmaceutyczne klewidypiny oraz sposoby ich wytwarzania z niskim stężeniem zanieczyszczeń - Google Patents

Kompozycje farmaceutyczne klewidypiny oraz sposoby ich wytwarzania z niskim stężeniem zanieczyszczeń

Info

Publication number
PL2320740T3
PL2320740T3 PL09803550T PL09803550T PL2320740T3 PL 2320740 T3 PL2320740 T3 PL 2320740T3 PL 09803550 T PL09803550 T PL 09803550T PL 09803550 T PL09803550 T PL 09803550T PL 2320740 T3 PL2320740 T3 PL 2320740T3
Authority
PL
Poland
Prior art keywords
clevidipine
methods
same
pharmaceutical compositions
low impurity
Prior art date
Application number
PL09803550T
Other languages
English (en)
Inventor
Rajeshwar Motheram
Gopal Krishna
Min Ding
Keith Flood
Kornepati Ramakrishna
Original Assignee
The Medicines Co
Hospira Inc
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=PL2320740(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by The Medicines Co, Hospira Inc filed Critical The Medicines Co
Publication of PL2320740T3 publication Critical patent/PL2320740T3/pl

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
    • 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
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—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 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column 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)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PL09803550T 2008-08-01 2009-07-29 Kompozycje farmaceutyczne klewidypiny oraz sposoby ich wytwarzania z niskim stężeniem zanieczyszczeń PL2320740T3 (pl)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US8559708P 2008-08-01 2008-08-01
US9377208P 2008-09-03 2008-09-03
EP09803550.4A EP2320740B1 (en) 2008-08-01 2009-07-29 Pharmaceutical compositions of clevidipine and methods for producing low impurity concentrations of the same
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
PL2320740T3 true PL2320740T3 (pl) 2014-09-30

Family

ID=41610719

Family Applications (1)

Application Number Title Priority Date Filing Date
PL09803550T PL2320740T3 (pl) 2008-08-01 2009-07-29 Kompozycje farmaceutyczne klewidypiny oraz sposoby ich wytwarzania z niskim stężeniem zanieczyszczeń

Country Status (20)

Country Link
US (6) US20100113534A1 (pl)
EP (2) EP2719386A1 (pl)
JP (1) JP5674660B2 (pl)
KR (1) KR101772602B1 (pl)
CN (1) CN102170786B (pl)
AU (1) AU2009276560B2 (pl)
BR (1) BRPI0916936B8 (pl)
CA (2) CA3108961C (pl)
CY (1) CY1116490T1 (pl)
DK (1) DK2320740T3 (pl)
EA (1) EA021336B1 (pl)
ES (1) ES2468837T3 (pl)
HR (1) HRP20140434T1 (pl)
MX (1) MX2011001240A (pl)
NZ (1) NZ591205A (pl)
PL (1) PL2320740T3 (pl)
PT (1) PT2320740E (pl)
SI (1) SI2320740T1 (pl)
SM (1) SMT201400081B (pl)
WO (1) WO2010014727A1 (pl)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010014727A1 (en) 2008-08-01 2010-02-04 The Medicines Company Pharmaceutical compositions and methods for producing low impurity concentrations of the same
PL2627173T5 (pl) * 2010-10-12 2019-11-29 Chiesi Farm Spa Formulacje emulsyjne klewidypiny zawierające środki przeciw mikrobom
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
KR102299073B1 (ko) 2012-10-26 2021-09-09 치에시 파마슈티시 에스.피.아. 심부전에서 혈압을 조절하고 호흡곤란을 감소시키는 방법
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
CA2947486C (en) * 2014-05-19 2023-09-26 The Medicines Company Clevidipine nanoparticles and pharmaceutical compositions thereof
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
WO2019123221A1 (en) * 2017-12-20 2019-06-27 Aurobindo Pharma Limited 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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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
ATE287714T1 (de) 1999-03-31 2005-02-15 Upjohn Co Pharmazeutische emulsionen für retroviral- protease hemmende verbindungen
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
EP1558252B1 (en) * 2002-08-02 2007-10-10 Merck & Co., Inc. Substituted furo [2,3-b]pyridine derivatives
EP1635773A2 (en) * 2003-06-06 2006-03-22 Merck & Co., Inc. (a New Jersey corp.) 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
WO2006118210A1 (ja) * 2005-04-28 2006-11-09 Eisai R & D Management Co., Ltd. ジヒドロピリジン系化合物の分解を防止する方法
US7737155B2 (en) * 2005-05-17 2010-06-15 Schering Corporation Nitrogen-containing heterocyclic compounds and methods of use thereof
MX2008001282A (es) * 2005-07-28 2008-03-24 Reliant Pharmaceuticals Inc Tratamiento con bloqueadores del canal del calcio de dihidropiridina y acidos grasos omega-3 y un producto de combinacion de los mismos.
WO2010014727A1 (en) 2008-08-01 2010-02-04 The Medicines Company Pharmaceutical compositions and methods for producing low impurity concentrations of the same
WO2010022259A1 (en) 2008-08-22 2010-02-25 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
PL2627173T5 (pl) 2010-10-12 2019-11-29 Chiesi Farm Spa Formulacje emulsyjne klewidypiny zawierające środki przeciw mikrobom

Also Published As

Publication number Publication date
BRPI0916936B1 (pt) 2020-08-04
JP5674660B2 (ja) 2015-02-25
KR101772602B1 (ko) 2017-08-29
DK2320740T3 (da) 2014-06-30
EP2719386A1 (en) 2014-04-16
US20250213540A1 (en) 2025-07-03
SMT201400081B (it) 2014-09-08
ES2468837T3 (es) 2014-06-17
EA021336B1 (ru) 2015-05-29
EP2320740A1 (en) 2011-05-18
US11058672B2 (en) 2021-07-13
JP2011529900A (ja) 2011-12-15
HRP20140434T1 (hr) 2014-08-01
CA2732760A1 (en) 2010-02-04
US20220000849A1 (en) 2022-01-06
BRPI0916936A2 (pt) 2017-05-23
CA3108961C (en) 2024-07-02
BRPI0916936A8 (pt) 2017-12-05
EA201170289A1 (ru) 2011-10-31
AU2009276560A1 (en) 2010-02-04
BRPI0916936B8 (pt) 2021-05-25
EP2320740B1 (en) 2014-03-26
EP2320740A4 (en) 2011-11-30
PT2320740E (pt) 2014-06-12
CN102170786B (zh) 2015-05-27
SI2320740T1 (sl) 2014-08-29
US20190091212A1 (en) 2019-03-28
KR20110060889A (ko) 2011-06-08
US20100113534A1 (en) 2010-05-06
CA3108961A1 (en) 2010-02-04
NZ591205A (en) 2012-11-30
CN102170786A (zh) 2011-08-31
US20120322835A1 (en) 2012-12-20
AU2009276560B2 (en) 2015-04-16
WO2010014727A1 (en) 2010-02-04
CY1116490T1 (el) 2017-03-15
US20140005233A1 (en) 2014-01-02
MX2011001240A (es) 2011-08-12

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