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.)
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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 (OSRAM) | 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 (OSRAM) |
| EP (1) | EP2627173B2 (OSRAM) |
| JP (3) | JP6040437B2 (OSRAM) |
| KR (2) | KR20130101080A (OSRAM) |
| CN (1) | CN103237446B (OSRAM) |
| AU (1) | AU2011313852B2 (OSRAM) |
| BR (1) | BR112013008601B1 (OSRAM) |
| CA (1) | CA2814495C (OSRAM) |
| DK (1) | DK2627173T4 (OSRAM) |
| EA (1) | EA022849B1 (OSRAM) |
| ES (1) | ES2539861T5 (OSRAM) |
| HU (1) | HUE026295T2 (OSRAM) |
| MX (2) | MX356537B (OSRAM) |
| NZ (1) | NZ610465A (OSRAM) |
| PL (1) | PL2627173T5 (OSRAM) |
| PT (1) | PT2627173E (OSRAM) |
| WO (1) | WO2012051116A1 (OSRAM) |
Families Citing this family (18)
| 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 |
| BR112013008601B1 (pt) | 2010-10-12 | 2020-03-31 | Chiesi Farmaceutici S.P.A. | Formulações de emulsão de clevidipina contendo agentes antimicrobianos |
| US8658676B2 (en) | 2010-10-12 | 2014-02-25 | The Medicines Company | Clevidipine emulsion formulations containing antimicrobial agents |
| JP2014509654A (ja) * | 2011-04-01 | 2014-04-21 | ザ メディシンズ カンパニー | 脳卒中損傷の低減に使用するための短時間作用型ジヒドロピリジン（クレビジピン） |
| UA117571C2 (uk) * | 2012-10-26 | 2018-08-27 | Чіесі Фармацеутічі С.П.А. | Способи контролювання кров'яного тиску та зниження диспное при серцевій недостатності |
| 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 |
| CN106456617A (zh) * | 2014-05-19 | 2017-02-22 | 医药公司 | 氯维地平纳米颗粒及其药物组合物 |
| 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 |
| CN111671725B (zh) * | 2018-01-26 | 2023-03-21 | 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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| BR112013008601B1 (pt) | 2010-10-12 | 2020-03-31 | Chiesi Farmaceutici S.P.A. | Formulações de emulsão de clevidipina contendo agentes antimicrobianos |
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2011
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