JP2014504259A5 - - Google Patents
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- JP2014504259A5 JP2014504259A5 JP2013533916A JP2013533916A JP2014504259A5 JP 2014504259 A5 JP2014504259 A5 JP 2014504259A5 JP 2013533916 A JP2013533916 A JP 2013533916A JP 2013533916 A JP2013533916 A JP 2013533916A JP 2014504259 A5 JP2014504259 A5 JP 2014504259A5
- Authority
- JP
- Japan
- Prior art keywords
- oil
- pharmaceutical formulation
- group
- pharmaceutically acceptable
- formulation according
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
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- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- -1 propylene glycol diester Chemical class 0.000 claims 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims 2
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 150000007513 acids Chemical class 0.000 claims 2
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims 2
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims 2
- KXGVEGMKQFWNSR-UHFFFAOYSA-N deoxycholic acid Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 KXGVEGMKQFWNSR-UHFFFAOYSA-N 0.000 claims 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims 2
- 239000003995 emulsifying agent Substances 0.000 claims 2
- 239000000194 fatty acid Substances 0.000 claims 2
- 229930195729 fatty acid Natural products 0.000 claims 2
- 150000002632 lipids Chemical class 0.000 claims 2
- 244000005700 microbiome Species 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims 2
- QIJRTFXNRTXDIP-UHFFFAOYSA-N (1-carboxy-2-sulfanylethyl)azanium;chloride;hydrate Chemical compound O.Cl.SCC(N)C(O)=O QIJRTFXNRTXDIP-UHFFFAOYSA-N 0.000 claims 1
- BHQCQFFYRZLCQQ-UHFFFAOYSA-N (3alpha,5alpha,7alpha,12alpha)-3,7,12-trihydroxy-cholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)C(O)C2 BHQCQFFYRZLCQQ-UHFFFAOYSA-N 0.000 claims 1
- LDVVTQMJQSCDMK-UHFFFAOYSA-N 1,3-dihydroxypropan-2-yl formate Chemical compound OCC(CO)OC=O LDVVTQMJQSCDMK-UHFFFAOYSA-N 0.000 claims 1
- 239000004380 Cholic acid Substances 0.000 claims 1
- IELOKBJPULMYRW-NJQVLOCASA-N D-alpha-Tocopheryl Acid Succinate Chemical compound OC(=O)CCC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C IELOKBJPULMYRW-NJQVLOCASA-N 0.000 claims 1
- 235000010469 Glycine max Nutrition 0.000 claims 1
- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims 1
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims 1
- 235000019483 Peanut oil Nutrition 0.000 claims 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 1
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims 1
- 235000019486 Sunflower oil Nutrition 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- 235000006708 antioxidants Nutrition 0.000 claims 1
- 235000010385 ascorbyl palmitate Nutrition 0.000 claims 1
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims 1
- 239000004359 castor oil Substances 0.000 claims 1
- 235000019438 castor oil Nutrition 0.000 claims 1
- 235000019416 cholic acid Nutrition 0.000 claims 1
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 claims 1
- 229960002471 cholic acid Drugs 0.000 claims 1
- 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 1
- 229960003597 clevidipine Drugs 0.000 claims 1
- 239000007957 coemulsifier Substances 0.000 claims 1
- 235000005687 corn oil Nutrition 0.000 claims 1
- 239000002285 corn oil Substances 0.000 claims 1
- 235000012343 cottonseed oil Nutrition 0.000 claims 1
- 239000002385 cottonseed oil Substances 0.000 claims 1
- 229960001305 cysteine hydrochloride Drugs 0.000 claims 1
- 229940099418 d- alpha-tocopherol succinate Drugs 0.000 claims 1
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 1
- 230000003111 delayed effect Effects 0.000 claims 1
- KXGVEGMKQFWNSR-LLQZFEROSA-N deoxycholic acid Chemical compound C([C@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 KXGVEGMKQFWNSR-LLQZFEROSA-N 0.000 claims 1
- 229960003964 deoxycholic acid Drugs 0.000 claims 1
- 239000008344 egg yolk phospholipid Substances 0.000 claims 1
- 229940068998 egg yolk phospholipid Drugs 0.000 claims 1
- 150000002148 esters Chemical class 0.000 claims 1
- 235000011187 glycerol Nutrition 0.000 claims 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims 1
- 239000001087 glyceryl triacetate Substances 0.000 claims 1
- 235000013773 glyceryl triacetate Nutrition 0.000 claims 1
- 239000008350 hydrogenated phosphatidyl choline Substances 0.000 claims 1
- 238000007654 immersion Methods 0.000 claims 1
- 239000002609 medium Substances 0.000 claims 1
- 230000000813 microbial effect Effects 0.000 claims 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid group Chemical group C(CCCCCCC\C=C/CCCCCCCC)(=O)O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims 1
- 239000004006 olive oil Substances 0.000 claims 1
- 235000008390 olive oil Nutrition 0.000 claims 1
- 239000000312 peanut oil Substances 0.000 claims 1
- 150000008105 phosphatidylcholines Chemical class 0.000 claims 1
- 150000003904 phospholipids Chemical class 0.000 claims 1
- 229920001983 poloxamer Polymers 0.000 claims 1
- 229920001987 poloxamine Polymers 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229940068965 polysorbates Drugs 0.000 claims 1
- 235000010388 propyl gallate Nutrition 0.000 claims 1
- 239000000473 propyl gallate Substances 0.000 claims 1
- 229940075579 propyl gallate Drugs 0.000 claims 1
- 239000008349 purified phosphatidyl choline Substances 0.000 claims 1
- 239000003813 safflower oil Substances 0.000 claims 1
- 239000008159 sesame oil Substances 0.000 claims 1
- 235000011803 sesame oil Nutrition 0.000 claims 1
- 235000010378 sodium ascorbate Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims 1
- 229960005055 sodium ascorbate Drugs 0.000 claims 1
- WBHQBSYUUJJSRZ-UHFFFAOYSA-M sodium bisulfate Chemical compound [Na+].OS([O-])(=O)=O WBHQBSYUUJJSRZ-UHFFFAOYSA-M 0.000 claims 1
- 229910000342 sodium bisulfate Inorganic materials 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 229960001790 sodium citrate Drugs 0.000 claims 1
- 235000011083 sodium citrates Nutrition 0.000 claims 1
- 229940079827 sodium hydrogen sulfite Drugs 0.000 claims 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims 1
- 235000010265 sodium sulphite Nutrition 0.000 claims 1
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims 1
- 239000003549 soybean oil Substances 0.000 claims 1
- 235000012424 soybean oil Nutrition 0.000 claims 1
- 239000002600 sunflower oil Substances 0.000 claims 1
- 239000008348 synthetic phosphatidyl choline Substances 0.000 claims 1
- 235000010384 tocopherol Nutrition 0.000 claims 1
- 239000011732 tocopherol Substances 0.000 claims 1
- 229960001295 tocopherol Drugs 0.000 claims 1
- 229930003799 tocopherol Natural products 0.000 claims 1
- 229960002622 triacetin Drugs 0.000 claims 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US39229410P | 2010-10-12 | 2010-10-12 | |
| US61/392,294 | 2010-10-12 | ||
| PCT/US2011/055617 WO2012051116A1 (en) | 2010-10-12 | 2011-10-10 | Clevidipine emulsion formulations containing antimicrobial agents |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014120354A Division JP6437743B2 (ja) | 2010-10-12 | 2014-06-11 | 抗菌剤を含むクレビジピン乳化製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2014504259A JP2014504259A (ja) | 2014-02-20 |
| JP2014504259A5 true JP2014504259A5 (enExample) | 2014-04-10 |
| JP6040437B2 JP6040437B2 (ja) | 2016-12-07 |
Family
ID=45925617
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013533916A Active JP6040437B2 (ja) | 2010-10-12 | 2011-10-10 | 抗菌剤を含むクレビジピン乳化製剤 |
| JP2014120354A Active JP6437743B2 (ja) | 2010-10-12 | 2014-06-11 | 抗菌剤を含むクレビジピン乳化製剤 |
| JP2016123498A Active JP6326094B2 (ja) | 2010-10-12 | 2016-06-22 | 抗菌剤を含むクレビジピン乳化製剤 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2014120354A Active JP6437743B2 (ja) | 2010-10-12 | 2014-06-11 | 抗菌剤を含むクレビジピン乳化製剤 |
| JP2016123498A Active JP6326094B2 (ja) | 2010-10-12 | 2016-06-22 | 抗菌剤を含むクレビジピン乳化製剤 |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US10010537B2 (enExample) |
| EP (1) | EP2627173B2 (enExample) |
| JP (3) | JP6040437B2 (enExample) |
| KR (2) | KR20130101080A (enExample) |
| CN (1) | CN103237446B (enExample) |
| AU (1) | AU2011313852B2 (enExample) |
| BR (1) | BR112013008601B1 (enExample) |
| CA (1) | CA2814495C (enExample) |
| DK (1) | DK2627173T4 (enExample) |
| EA (1) | EA022849B1 (enExample) |
| ES (1) | ES2539861T5 (enExample) |
| HU (1) | HUE026295T2 (enExample) |
| MX (2) | MX356537B (enExample) |
| NZ (1) | NZ610465A (enExample) |
| PL (1) | PL2627173T5 (enExample) |
| PT (1) | PT2627173E (enExample) |
| WO (1) | WO2012051116A1 (enExample) |
Families Citing this family (18)
| 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 |
| 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 |
| WO2014066870A1 (en) * | 2012-10-26 | 2014-05-01 | The Medicines Company | Methods for controlling blood pressure and reducing dyspnea in heart failure |
| CN103169672A (zh) * | 2012-12-26 | 2013-06-26 | 辰欣药业股份有限公司 | 一种丁酸氯维地平冻干乳剂 |
| CN103110580B (zh) * | 2013-02-20 | 2014-09-17 | 北京德立福瑞医药科技有限公司 | 丁酸氯维地平注射剂 |
| CN103126986A (zh) * | 2013-03-19 | 2013-06-05 | 董慧芳 | 一种丁酸氯维地平静脉注射用乳剂及其制备方法 |
| TW201538181A (zh) * | 2014-03-19 | 2015-10-16 | Pures Biotech Co Ltd | 用於潤滑保濕消毒滅菌之半流體組成物及其使用方法 |
| KR102380701B1 (ko) * | 2014-05-19 | 2022-03-31 | 치에시 파마슈티시 에스.피.아. | 클레비디핀 나노입자 및 그의 제약적 조성물 |
| CN105456189A (zh) * | 2014-09-12 | 2016-04-06 | 武汉大安制药有限公司 | 一种丁酸氯维地平乳剂注射剂及其制备方法 |
| CN104523590B (zh) * | 2014-12-09 | 2017-09-15 | 山东威高药业股份有限公司 | 一种丁酸氯维地平脂肪乳注射液 |
| CN107661294B (zh) * | 2016-07-27 | 2020-04-14 | 武汉科福新药有限责任公司 | 抗高血压药物脂肪乳注射剂及其制备方法 |
| US20200316043A1 (en) * | 2017-12-20 | 2020-10-08 | Aurobindo Pharma Ltd. | Pharmaceutical composition comprising clevidipine and process for preparation thereof |
| CN108324703B (zh) * | 2018-01-26 | 2020-07-28 | 中国医学科学院阜外医院 | 用于保护缺血心肌的注射剂及其制备方法 |
| CN109602704A (zh) * | 2019-01-23 | 2019-04-12 | 广东嘉博制药有限公司 | 丁酸氯维地平脂肪乳注射液及其制备工艺 |
| 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 |
| US11135208B2 (en) | 2019-08-12 | 2021-10-05 | American Regent, Inc. | 1,4-dihydropyridine compositions, methods of making and use |
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| CN101791311A (zh) | 2009-12-31 | 2010-08-04 | 广州中大创新药物研究与开发中心有限公司 | 一种具有短效降压作用的药物组合物 |
| 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 |
| HUE026295T2 (en) | 2010-10-12 | 2016-06-28 | The Medicines Co | Clevidipine emulsion formulations containing antimicrobial agents |
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2011
- 2011-10-10 HU HUE11833207A patent/HUE026295T2/en unknown
- 2011-10-10 AU AU2011313852A patent/AU2011313852B2/en active Active
- 2011-10-10 MX MX2014014773A patent/MX356537B/es unknown
- 2011-10-10 KR KR1020137012057A patent/KR20130101080A/ko not_active Ceased
- 2011-10-10 KR KR1020167006219A patent/KR101786857B1/ko active Active
- 2011-10-10 US US13/270,004 patent/US10010537B2/en active Active
- 2011-10-10 JP JP2013533916A patent/JP6040437B2/ja active Active
- 2011-10-10 BR BR112013008601-7A patent/BR112013008601B1/pt active IP Right Grant
- 2011-10-10 MX MX2013004151A patent/MX2013004151A/es active IP Right Grant
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- 2011-10-10 CN CN201180048865.XA patent/CN103237446B/zh not_active Ceased
- 2011-10-10 EA EA201390541A patent/EA022849B1/ru unknown
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2016
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