EA201170289A1 - Фармацевтические композиции и способы их получения при низкой концентрации примесей - Google Patents

Фармацевтические композиции и способы их получения при низкой концентрации примесей

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Publication number
EA201170289A1
EA201170289A1 EA201170289A EA201170289A EA201170289A1 EA 201170289 A1 EA201170289 A1 EA 201170289A1 EA 201170289 A EA201170289 A EA 201170289A EA 201170289 A EA201170289 A EA 201170289A EA 201170289 A1 EA201170289 A1 EA 201170289A1
Authority
EA
Eurasian Patent Office
Prior art keywords
impurities
production
methods
pharmaceutical compositions
low concentration
Prior art date
Application number
EA201170289A
Other languages
English (en)
Other versions
EA021336B1 (ru
Inventor
Раджешвар Мозерам
Гопал Кришна
Минь Дин
Кейт Флад
Корнепати Рамакришна
Original Assignee
Дзе Медсинз Компани
Хоспира, Инк.
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=EA201170289(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Дзе Медсинз Компани, Хоспира, Инк. filed Critical Дзе Медсинз Компани
Publication of EA201170289A1 publication Critical patent/EA201170289A1/ru
Publication of EA021336B1 publication Critical patent/EA021336B1/ru

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)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Описывается композиция, имеющая клевидипин в качестве активного ингредиента. Композиция содержит клевидипин в качестве активного ингредиента и содержание примеси Н168/79, которое не больше примерно чем 1,5%, или где отношение клевидипина к Н168/79 равно или выше чем 60:1.
EA201170289A 2008-08-01 2009-07-29 Фармацевтические композиции и способы их получения при низкой концентрации примесей EA021336B1 (ru)

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 (2)

Publication Number Publication Date
EA201170289A1 true EA201170289A1 (ru) 2011-10-31
EA021336B1 EA021336B1 (ru) 2015-05-29

Family

ID=41610719

Family Applications (1)

Application Number Title Priority Date Filing Date
EA201170289A EA021336B1 (ru) 2008-08-01 2009-07-29 Фармацевтические композиции и способы их получения при низкой концентрации примесей

Country Status (20)

Country Link
US (5) US20100113534A1 (ru)
EP (2) EP2320740B1 (ru)
JP (1) JP5674660B2 (ru)
KR (1) KR101772602B1 (ru)
CN (1) CN102170786B (ru)
AU (1) AU2009276560B2 (ru)
BR (1) BRPI0916936B8 (ru)
CA (2) CA3108961A1 (ru)
CY (1) CY1116490T1 (ru)
DK (1) DK2320740T3 (ru)
EA (1) EA021336B1 (ru)
ES (1) ES2468837T3 (ru)
HR (1) HRP20140434T1 (ru)
MX (1) MX2011001240A (ru)
NZ (1) NZ591205A (ru)
PL (1) PL2320740T3 (ru)
PT (1) PT2320740E (ru)
SI (1) SI2320740T1 (ru)
SM (1) SMT201400081B (ru)
WO (1) WO2010014727A1 (ru)

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AU2009276560B2 (en) 2008-08-01 2015-04-16 Chiesi Farmaceutici S.P.A. Pharmaceutical compositions and methods for producing low impurity concentrations of the same
AU2011313852B2 (en) * 2010-10-12 2015-07-02 Chiesi Farmaceutici S.P.A. 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
JP6329957B2 (ja) 2012-10-26 2018-05-23 キエージィ ファーマチェウティチ エス．ペー．アー． 心不全において血圧を制御するためおよび呼吸困難を低減させるための方法
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
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
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
RU2759673C2 (ru) * 2014-05-19 2021-11-16 КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. Наночастицы клевидипина и их фармацевтические композиции
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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US8658676B2 (en) 2010-10-12 2014-02-25 The Medicines Company Clevidipine emulsion formulations containing antimicrobial agents
AU2011313852B2 (en) 2010-10-12 2015-07-02 Chiesi Farmaceutici S.P.A. Clevidipine emulsion formulations containing antimicrobial agents

Also Published As

Publication number Publication date
EP2320740A1 (en) 2011-05-18
DK2320740T3 (da) 2014-06-30
AU2009276560A1 (en) 2010-02-04
PT2320740E (pt) 2014-06-12
BRPI0916936A2 (pt) 2017-05-23
US20220000849A1 (en) 2022-01-06
KR20110060889A (ko) 2011-06-08
CN102170786B (zh) 2015-05-27
KR101772602B1 (ko) 2017-08-29
CA2732760A1 (en) 2010-02-04
AU2009276560B2 (en) 2015-04-16
WO2010014727A1 (en) 2010-02-04
EA021336B1 (ru) 2015-05-29
NZ591205A (en) 2012-11-30
US20100113534A1 (en) 2010-05-06
MX2011001240A (es) 2011-08-12
JP5674660B2 (ja) 2015-02-25
US20190091212A1 (en) 2019-03-28
BRPI0916936B8 (pt) 2021-05-25
CN102170786A (zh) 2011-08-31
US20120322835A1 (en) 2012-12-20
ES2468837T3 (es) 2014-06-17
PL2320740T3 (pl) 2014-09-30
US20140005233A1 (en) 2014-01-02
EP2320740A4 (en) 2011-11-30
US11058672B2 (en) 2021-07-13
CY1116490T1 (el) 2017-03-15
SMT201400081B (it) 2014-09-08
JP2011529900A (ja) 2011-12-15
CA3108961A1 (en) 2010-02-04
BRPI0916936B1 (pt) 2020-08-04
BRPI0916936A8 (pt) 2017-12-19
EP2320740B1 (en) 2014-03-26
HRP20140434T1 (hr) 2014-08-01
SI2320740T1 (sl) 2014-08-29
EP2719386A1 (en) 2014-04-16

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Designated state(s): AM AZ BY KZ KG MD TJ TM

PC4A Registration of transfer of a eurasian patent by assignment