HRP20140434T1 - Farmaceutski sastav clevidipine-a i metode za proizvodnju istih sa niskim koncentracijama neäśistoä†a - Google Patents
Farmaceutski sastav clevidipine-a i metode za proizvodnju istih sa niskim koncentracijama neäśistoä†a Download PDFInfo
- Publication number
- HRP20140434T1 HRP20140434T1 HRP20140434AT HRP20140434T HRP20140434T1 HR P20140434 T1 HRP20140434 T1 HR P20140434T1 HR P20140434A T HRP20140434A T HR P20140434AT HR P20140434 T HRP20140434 T HR P20140434T HR P20140434 T1 HRP20140434 T1 HR P20140434T1
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- Prior art keywords
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- composition
- mixture
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Links
- 238000000034 method Methods 0.000 title claims 7
- 239000012535 impurity Substances 0.000 title claims 4
- 239000008194 pharmaceutical composition Substances 0.000 title claims 4
- 239000000203 mixture Substances 0.000 claims 15
- 239000007857 degradation product Substances 0.000 claims 7
- KPBZROQVTHLCDU-GOSISDBHSA-N clevidipine Chemical compound CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)[C@H]1C1=CC=CC(Cl)=C1Cl KPBZROQVTHLCDU-GOSISDBHSA-N 0.000 claims 5
- 229960003597 clevidipine Drugs 0.000 claims 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 4
- 239000008346 aqueous phase Substances 0.000 claims 4
- 238000010438 heat treatment Methods 0.000 claims 4
- 239000000047 product Substances 0.000 claims 3
- 238000000354 decomposition reaction Methods 0.000 claims 2
- 210000002969 egg yolk Anatomy 0.000 claims 2
- 239000000839 emulsion Substances 0.000 claims 2
- 235000011187 glycerol Nutrition 0.000 claims 2
- 150000003904 phospholipids Chemical class 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000002002 slurry Substances 0.000 claims 2
- 206010020772 Hypertension Diseases 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 230000015556 catabolic process Effects 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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)
Claims (12)
1. Farmaceutski sastav koji sadrži clevidipine ili bilo koju od njegovih farmaceutski prihvatljivih soli kao aktivnu supstancu, a čiji proizvod razgradnje ima sljedeću formulu:
[image]
gdje je količina proizvoda razgradnje približno jednaka ili manja od oko 1.5% iskazano na bazi mase i gdje je farmaceutski sastav pripremljen kao emulzija tipa ulja u vodi koja ima pH od oko 6 do oko 8.8.
2. Sastav prema zahtjevu 1, gdje je nivo proizvoda razgradnje H168/79 u sastavu približno jednak ili manji od oko 1.5% kada se sastav čuva na odgovarajućoj temperaturi.
3. Farmaceutski sastav koji sadrži clevidipine ili bilo koju od njegovih farmaceutski prihvatljivih soli kao aktivni sastojak, pripremljen procesom koji obuhvaća:
Zagrijavanje ulja na temperaturu od oko70°C do oko82°C;
Dodavanje clevidipine-a zagrijanomuljuizagrijevanjemješavinenaoko78°C do 82°C;
Dodavanje fosfolipida iz žumanjka mješavini; i
Dodavanje vodene faze;
Gdje vodena faza u osnovi sadrži glicerin a pH je podešen na od oko 6 do oko 8.8;i
gdje je količina proizvoda razgradnje sa sljedećom formulom:
[image]
Približno jednaka ili manja od oko 1.5%.
4. Sastav prema bilo kojem od zahtjeva 1 do 3, gdje je količina proizvoda razgradnje H168/79 približno jednaka ili manja od oko1.0%.
5. Sastav zahtjeva 4, gdje je količina proizvoda razgradnje H168/79 približno jednaka ili manja od oko0.5%.
6. Sastav prema zahtjevima od 1 do 5, gdje sastav dalje uključuje smanjeni nivo jednog ili više proizvoda razgradnje izabranih iz grupe koja sadrži:
[image]
i
[image]
gdje sastavi sadrže jednako ili ne više od 0.2% svake nečistoće na bazi mase nečistoće prema masi clevidipine-a.
7. Sastav prema bilo kojem od prethodnih zahtjeva za upotrebu u liječenju ili prevenciji hipertenzije.
8. Metoda za smanjenje nečistoća u sastavu prema zahtjevima 1 i 2 i zahtjevima 4 do 6 a što zavisi od zahtjeva 1, koja uključuje:
zagrijevanje ulja na temperaturu od oko70°C do oko82°C;
dodavanje clevidipine-a zagrijanomuljuizagrijevanjemješavinenaoko78°C do 82°C;
dodavanje fosfolipida iz žumanjka mješavini; i
dodavanje vodene faze;
gdje je pH je podešen na od oko 6 do oko 8.8; i
homogeniziranje emulzije; i
gdje je količina proizvoda razgradnje sa formulom:
[image]
približno jednaka ili manja od oko1.5%.
9. Metoda zahtjeva 8, gdje je količina proizvoda razgradnje H168/79 približno jednaka ili manja od oko1.0%.
10. Metoda zahtjeva 9, gdje je količina proizvoda razgradnje H168/79 približno jednaka ili manja od oko0.5%.
11. Metoda prema bilo kojem od zahtjeva 8 do 10, gdje vodena faza sadrži u osnovi glicerin.
12. Metoda prema bilo kojem od zahtjeva 8 do 10, gdje je mješavina homogenizirana na oko 25°C, po mogućnosti na oko15°C, prije na oko10°C, a najprije na oko5°C.
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 |
|---|---|
| HRP20140434T1 true HRP20140434T1 (hr) | 2014-08-01 |
Family
ID=41610719
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20140434AT HRP20140434T1 (hr) | 2008-08-01 | 2014-05-13 | Farmaceutski sastav clevidipine-a i metode za proizvodnju istih sa niskim koncentracijama neäśistoä†a |
Country Status (20)
| Country | Link |
|---|---|
| US (5) | US20100113534A1 (hr) |
| EP (2) | EP2719386A1 (hr) |
| JP (1) | JP5674660B2 (hr) |
| KR (1) | KR101772602B1 (hr) |
| CN (1) | CN102170786B (hr) |
| AU (1) | AU2009276560B2 (hr) |
| BR (1) | BRPI0916936B8 (hr) |
| CA (2) | CA3108961A1 (hr) |
| CY (1) | CY1116490T1 (hr) |
| DK (1) | DK2320740T3 (hr) |
| EA (1) | EA021336B1 (hr) |
| ES (1) | ES2468837T3 (hr) |
| HR (1) | HRP20140434T1 (hr) |
| MX (1) | MX2011001240A (hr) |
| NZ (1) | NZ591205A (hr) |
| PL (1) | PL2320740T3 (hr) |
| PT (1) | PT2320740E (hr) |
| SI (1) | SI2320740T1 (hr) |
| SM (1) | SMT201400081B (hr) |
| WO (1) | WO2010014727A1 (hr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ591205A (en) | 2008-08-01 | 2012-11-30 | Medicines Co | Pharmaceutical compositions comprising clevidipine and methods for producing low impurity concentrations of the same |
| NZ610465A (en) * | 2010-10-12 | 2015-05-29 | 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 |
| CN104968199A (zh) | 2012-10-26 | 2015-10-07 | 医药公司 | 用于在心力衰竭中控制血压和减轻呼吸困难的方法 |
| 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 |
| WO2015179334A1 (en) * | 2014-05-19 | 2015-11-26 | 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 |
Family Cites Families (24)
| 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 |
| US6956048B2 (en) * | 1999-03-31 | 2005-10-18 | Pharmacia & Upjohn Company | Pharmaceutical emulsions for retroviral protease inhibitors |
| WO2000057885A1 (en) | 1999-03-31 | 2000-10-05 | 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 |
| AU2003257145B2 (en) * | 2002-08-02 | 2008-11-13 | Merck Sharp & Dohme Corp. | Substituted furo (2,3-b) pyridine derivatives |
| US20060160834A1 (en) * | 2003-06-06 | 2006-07-20 | Fong Tung M | 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 |
| CN101068546A (zh) | 2004-10-06 | 2007-11-07 | 卫材R&D管理有限公司 | 医药组合物及其制造方法以及医药组合物中的二氢吡啶类化合物的稳定化方法 |
| 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 |
| NZ591205A (en) | 2008-08-01 | 2012-11-30 | Medicines Co | Pharmaceutical compositions comprising clevidipine 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 |
| NZ610465A (en) | 2010-10-12 | 2015-05-29 | 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 |
-
2009
- 2009-07-29 NZ NZ591205A patent/NZ591205A/xx unknown
- 2009-07-29 CA CA3108961A patent/CA3108961A1/en active Pending
- 2009-07-29 EP EP14150954.7A patent/EP2719386A1/en not_active Withdrawn
- 2009-07-29 WO PCT/US2009/052127 patent/WO2010014727A1/en active Application Filing
- 2009-07-29 AU AU2009276560A patent/AU2009276560B2/en active Active
- 2009-07-29 DK DK09803550.4T patent/DK2320740T3/da active
- 2009-07-29 SI SI200930923T patent/SI2320740T1/sl unknown
- 2009-07-29 JP JP2011521291A patent/JP5674660B2/ja active Active
- 2009-07-29 US US12/511,631 patent/US20100113534A1/en not_active Abandoned
- 2009-07-29 CN CN200980139203.6A patent/CN102170786B/zh active Active
- 2009-07-29 KR KR1020117004358A patent/KR101772602B1/ko active IP Right Grant
- 2009-07-29 ES ES09803550.4T patent/ES2468837T3/es active Active
- 2009-07-29 BR BRPI0916936A patent/BRPI0916936B8/pt active IP Right Grant
- 2009-07-29 CA CA2732760A patent/CA2732760A1/en not_active Abandoned
- 2009-07-29 PT PT98035504T patent/PT2320740E/pt unknown
- 2009-07-29 MX MX2011001240A patent/MX2011001240A/es active IP Right Grant
- 2009-07-29 EP EP09803550.4A patent/EP2320740B1/en active Active
- 2009-07-29 EA EA201170289A patent/EA021336B1/ru not_active IP Right Cessation
- 2009-07-29 PL PL09803550T patent/PL2320740T3/pl unknown
-
2012
- 2012-08-30 US US13/600,056 patent/US20120322835A1/en not_active Abandoned
-
2013
- 2013-06-17 US US13/919,893 patent/US20140005233A1/en not_active Abandoned
-
2014
- 2014-05-13 HR HRP20140434AT patent/HRP20140434T1/hr unknown
- 2014-05-30 CY CY20141100388T patent/CY1116490T1/el unknown
- 2014-06-25 SM SM201400081T patent/SMT201400081B/xx unknown
-
2018
- 2018-11-21 US US16/197,647 patent/US11058672B2/en active Active
-
2021
- 2021-06-16 US US17/304,216 patent/US20220000849A1/en active Pending
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