KR102459416B1 - 포스네투피탄트의 생리학적으로 균형잡힌 주사가능 제제 - Google Patents
포스네투피탄트의 생리학적으로 균형잡힌 주사가능 제제 Download PDFInfo
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- KR102459416B1 KR102459416B1 KR1020187034943A KR20187034943A KR102459416B1 KR 102459416 B1 KR102459416 B1 KR 102459416B1 KR 1020187034943 A KR1020187034943 A KR 1020187034943A KR 20187034943 A KR20187034943 A KR 20187034943A KR 102459416 B1 KR102459416 B1 KR 102459416B1
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- South Korea
- Prior art keywords
- formulation
- fosnetupitant
- weight
- sodium hydroxide
- palonosetron
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- HZIYEEMJNBKMJH-UHFFFAOYSA-N [4-[5-[[2-[3,5-bis(trifluoromethyl)phenyl]-2-methylpropanoyl]-methylamino]-4-(2-methylphenyl)pyridin-2-yl]-1-methylpiperazin-1-ium-1-yl]methyl hydrogen phosphate Chemical compound C=1N=C(N2CC[N+](C)(COP(O)([O-])=O)CC2)C=C(C=2C(=CC=CC=2)C)C=1N(C)C(=O)C(C)(C)C1=CC(C(F)(F)F)=CC(C(F)(F)F)=C1 HZIYEEMJNBKMJH-UHFFFAOYSA-N 0.000 title claims abstract description 105
- 229950010727 fosnetupitant Drugs 0.000 title claims abstract description 103
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- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 87
- 239000012458 free base Substances 0.000 claims description 47
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 34
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- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 31
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- OLDRWYVIKMSFFB-SSPJITILSA-N palonosetron hydrochloride Chemical compound Cl.C1N(CC2)CCC2[C@@H]1N1C(=O)C(C=CC=C2CCC3)=C2[C@H]3C1 OLDRWYVIKMSFFB-SSPJITILSA-N 0.000 claims description 22
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- CPZBLNMUGSZIPR-NVXWUHKLSA-N palonosetron Chemical compound C1N(CC2)CCC2[C@@H]1N1C(=O)C(C=CC=C2CCC3)=C2[C@H]3C1 CPZBLNMUGSZIPR-NVXWUHKLSA-N 0.000 claims description 18
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- A61K31/33—Heterocyclic compounds
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
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- 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
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
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- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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| US201662345942P | 2016-06-06 | 2016-06-06 | |
| US62/345,942 | 2016-06-06 | ||
| PCT/EP2017/063268 WO2017211663A1 (en) | 2016-06-06 | 2017-06-01 | Physiologically balanced injectable formulations of fosnetupitant |
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| KR20190015276A KR20190015276A (ko) | 2019-02-13 |
| KR102459416B1 true KR102459416B1 (ko) | 2022-10-27 |
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| US11654154B2 (en) | 2019-01-29 | 2023-05-23 | Navinta Iii Inc | Process for preparing injectable Fosaprepitant Dimeglumine compositions having improved storage stability |
| US12097197B2 (en) | 2021-12-21 | 2024-09-24 | Slayback Pharma Llc | Stable liquid compositions of netupitant and palonosetron |
| JP7783403B2 (ja) * | 2022-03-23 | 2025-12-09 | 大鵬薬品工業株式会社 | ホスネツピタント又はその医薬上許容される塩の安定化製剤およびその製造方法 |
| WO2025036703A1 (en) * | 2023-08-13 | 2025-02-20 | Helsinn Healthcare Sa | Fosnetupitant for administration via intravenous bolus |
| WO2025056094A1 (zh) * | 2023-09-15 | 2025-03-20 | 广州帝奇医药技术有限公司 | 一种冻干制剂和注射液及其制备方法 |
| CN119185243A (zh) * | 2024-11-28 | 2024-12-27 | 山东齐都药业有限公司 | 福奈妥匹坦帕洛诺司琼口服掩味颗粒剂及其制备方法与应用 |
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| US20060167072A1 (en) * | 2004-01-30 | 2006-07-27 | Helsinn Healthcare Sa | Liquid pharmaceutical formulations of palonosetron |
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| IL111960A (en) | 1993-12-17 | 1999-12-22 | Merck & Co Inc | Morpholines and thiomorpholines their preparation and pharmaceutical compositions containing them |
| KR100286412B1 (ko) | 1993-12-29 | 2001-04-16 | 더블유. 지. 콜 | 치환된 모르폴린 유도체, 이의 제조방법 및 이를 포함하는 약제학적 조성물 |
| IL112778A0 (en) | 1994-03-04 | 1995-05-26 | Merck & Co Inc | Substituted heterocycles, their preparation and pharmaceutical compositions containing them |
| JO2735B1 (en) * | 2003-01-30 | 2013-09-15 | هيلسين هيلث كير أس ايه. | Liquid pharmaceutical formations of balloonosterone |
| US20100048607A1 (en) * | 2008-08-25 | 2010-02-25 | Chandrashekhar Kocherlakota | Formulations comprising palonosetron |
| US8426450B1 (en) | 2011-11-29 | 2013-04-23 | Helsinn Healthcare Sa | Substituted 4-phenyl pyridines having anti-emetic effect |
| EP2866797B1 (en) * | 2012-07-06 | 2020-04-29 | Pharmathen S.A. | Stable injectable pharmaceutical composition of neurokinin 1 receptor antagonist and process for preparation thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060167072A1 (en) * | 2004-01-30 | 2006-07-27 | Helsinn Healthcare Sa | Liquid pharmaceutical formulations of palonosetron |
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