RU2015122023A - Стабилизированная композиция пеметрекседа - Google Patents
Стабилизированная композиция пеметрекседа Download PDFInfo
- Publication number
- RU2015122023A RU2015122023A RU2015122023A RU2015122023A RU2015122023A RU 2015122023 A RU2015122023 A RU 2015122023A RU 2015122023 A RU2015122023 A RU 2015122023A RU 2015122023 A RU2015122023 A RU 2015122023A RU 2015122023 A RU2015122023 A RU 2015122023A
- Authority
- RU
- Russia
- Prior art keywords
- pemetrexed
- composition
- pemetrexed composition
- salt
- cysteine
- Prior art date
Links
- QOFFJEBXNKRSPX-ZDUSSCGKSA-N pemetrexed Chemical compound C1=N[C]2NC(N)=NC(=O)C2=C1CCC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 QOFFJEBXNKRSPX-ZDUSSCGKSA-N 0.000 title claims 10
- 229960005079 pemetrexed Drugs 0.000 title claims 10
- 150000001860 citric acid derivatives Chemical class 0.000 claims 4
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical group O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Anti-Oxidant Or Stabilizer Compositions (AREA)
Claims (6)
1. Композиция пеметрекседа, содержащая пеметрексед или его фармацевтически приемлемую соль в качестве активного ингредиента; N-ацетил-L-цистеин и цитратную соль.
2. Композиция пеметрекседа по п. 1, где отношение концентраций пеметрексед или его фармацевтически приемлемая соль N-ацетил-L-цистеин: цитратная соль составляет 1-30:0,15-2,0:1,0-15,0.
3. Композиция пеметрекседа по п. 2, где отношение концентраций пеметрексед или его фармацевтически приемлемая соль N-ацетил-L-цистеин: цитратная соль составляет 1-30:1,5:1,0-15,0.
4. Композиция пеметрекседа по п. 1, где цитратная соль представляет собой цитрат натрия.
5. Композиция пеметрекседа по п. 1, представляющая собой жидкую композицию, которую можно хранить в состоянии раствора.
6. Композиция пеметрекседа по п. 1, представляющая собой инъекционную жидкую композицию, содержащуюся в герметичном контейнере, таким образом, что она является готовой к применению.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR10-2012-0137375 | 2012-11-29 | ||
| KR1020120137375A KR101260636B1 (ko) | 2012-11-29 | 2012-11-29 | 안정화된 페메트렉시드 제제 |
| PCT/KR2013/010967 WO2014084651A1 (en) | 2012-11-29 | 2013-11-29 | A stabilized pemetrexed formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015122023A true RU2015122023A (ru) | 2017-01-10 |
| RU2620341C2 RU2620341C2 (ru) | 2017-05-24 |
Family
ID=48665454
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015122023A RU2620341C2 (ru) | 2012-11-29 | 2013-11-29 | Стабилизированная композиция пеметрекседа |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US9265832B2 (ru) |
| EP (1) | EP2925325B1 (ru) |
| JP (1) | JP5934448B2 (ru) |
| KR (1) | KR101260636B1 (ru) |
| CN (1) | CN104812392B (ru) |
| AR (1) | AR093645A1 (ru) |
| BR (1) | BR112015012460B1 (ru) |
| CL (1) | CL2015001461A1 (ru) |
| ES (1) | ES2656901T3 (ru) |
| HK (1) | HK1212224A1 (ru) |
| JO (1) | JOP20130342B1 (ru) |
| MX (1) | MX355461B (ru) |
| PH (1) | PH12015500900B1 (ru) |
| RU (1) | RU2620341C2 (ru) |
| TW (1) | TWI498128B (ru) |
| WO (1) | WO2014084651A1 (ru) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102012010774A1 (de) * | 2012-05-31 | 2013-12-05 | Stada Arzneimittel Ag | Pharmazeutische Pemetrexed-Lösung |
| KR101485243B1 (ko) * | 2013-05-08 | 2015-01-21 | 씨제이헬스케어 주식회사 | 안정화된 페메트렉시드 제제 |
| JP6094388B2 (ja) * | 2013-06-07 | 2017-03-15 | ニプロ株式会社 | ペメトレキセドを含む注射用組成物 |
| PL3040074T3 (pl) | 2013-10-03 | 2019-03-29 | Fujifilm Corporation | Preparat iniekcyjny i sposób jego wytwarzania |
| JP6120766B2 (ja) * | 2013-12-27 | 2017-04-26 | 富士フイルム株式会社 | 注射液製剤及びその製造方法 |
| KR101703980B1 (ko) | 2013-12-30 | 2017-02-08 | 주식회사 삼양바이오팜 | 항산화제를 함유하지 않는 약학 조성물 및 그의 제조방법 |
| ES2686870T3 (es) * | 2014-03-28 | 2018-10-22 | Fujifilm Corporation | Preparación de inyección y método para producirla |
| GB201418555D0 (en) * | 2014-10-16 | 2014-12-03 | Teva Gmbh | Pemetrexed formulations |
| KR101770605B1 (ko) * | 2014-11-17 | 2017-08-23 | 동아에스티 주식회사 | 페메트렉시드 또는 그것의 약제학적으로 허용가능 한 염을 함유하는 안정한 약제학적 조성물 |
| KR101919436B1 (ko) | 2015-05-28 | 2018-11-16 | 주식회사 삼양바이오팜 | 안정화된 약학 조성물 및 그의 제조방법 |
| KR101693675B1 (ko) | 2015-12-14 | 2017-01-06 | 주식회사 종근당 | 페메트렉시드 또는 그의 약제학적으로 허용가능한 염을 함유하는 안정화된 약학조성물 |
| JP6837895B2 (ja) * | 2017-04-04 | 2021-03-03 | 日本化薬株式会社 | 医薬品溶液製剤の製造方法 |
| US20200246263A1 (en) * | 2017-08-29 | 2020-08-06 | Fresenius Kabi Oncology Limited | Stable liquid compositions of pemetrexed |
| KR102040034B1 (ko) | 2017-12-13 | 2019-11-05 | 주식회사 아이큐어비앤피 | 페메트렉시드를 포함하는 경구용 약학 조성물 및 이의 제조방법 |
| US10966982B2 (en) | 2018-11-20 | 2021-04-06 | Cipla Limited | Stable pharmaceutical formulations of pemetrexed |
| US20230201203A1 (en) * | 2020-04-09 | 2023-06-29 | Emphascience, Inc. | Methods of treatment using antifolates and pharmaceutical formulations comprising antifolates |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR0162654B1 (ko) | 1989-12-11 | 1998-11-16 | 알렌 제이. 시니스갤리 | N-(피롤로[2,3-d]피리미딘-3-일아크릴)-글루타민산 유도체 |
| CA2032695A1 (en) | 1989-12-20 | 1991-06-21 | Hiroshi Akimoto | Condensed heterocyclic compounds, their production and use |
| TR200401436T4 (tr) * | 2000-02-04 | 2004-07-21 | Eli Lilly And Company | Monotiyogliserol, L-sistem veya tiyoglikolik asitle birlikte pemetrexed içeren farmasötik bileşim |
| US6686365B2 (en) * | 2000-02-04 | 2004-02-03 | Eli Lilly And Company | Pharmaceutical composition |
| KR100774366B1 (ko) | 2001-09-10 | 2007-11-08 | 주식회사 중외제약 | 파클리탁셀 주사제 조성물 |
| CH697021A5 (de) * | 2003-06-26 | 2008-03-31 | Merck Eprova Ag | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
| DK1767219T3 (da) | 2004-03-10 | 2010-05-10 | Shimoda Biotech Pty Ltd | Stabile injicerbare diclofenac-sammensætninger |
| KR101083230B1 (ko) * | 2006-08-14 | 2011-11-11 | 시코르, 인크. | 페메트렉세드 이산의 동결 건조된 약학적 허용염의 제조 방법 |
| EP2072518A1 (en) * | 2007-12-23 | 2009-06-24 | Sun Pharma Advanced Research Company Limited | Stable Amorphous Form of Pemextred Disodium |
| JP2013540104A (ja) | 2010-07-28 | 2013-10-31 | イーグル・ファーマシューティカルズ・インコーポレーテッド | 延長された保存安定性を有するペメトレキセドを含有する医薬組成物 |
| KR101069128B1 (ko) * | 2011-03-10 | 2011-09-30 | 건일제약 주식회사 | 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법 |
| DE102012010774A1 (de) * | 2012-05-31 | 2013-12-05 | Stada Arzneimittel Ag | Pharmazeutische Pemetrexed-Lösung |
| KR101485243B1 (ko) * | 2013-05-08 | 2015-01-21 | 씨제이헬스케어 주식회사 | 안정화된 페메트렉시드 제제 |
-
2012
- 2012-11-29 KR KR1020120137375A patent/KR101260636B1/ko active IP Right Grant
-
2013
- 2013-11-27 JO JOP/2013/0342A patent/JOP20130342B1/ar active
- 2013-11-28 TW TW102143402A patent/TWI498128B/zh active
- 2013-11-28 AR ARP130104389A patent/AR093645A1/es not_active Application Discontinuation
- 2013-11-29 ES ES13858153.3T patent/ES2656901T3/es active Active
- 2013-11-29 EP EP13858153.3A patent/EP2925325B1/en active Active
- 2013-11-29 US US14/646,615 patent/US9265832B2/en active Active
- 2013-11-29 CN CN201380062109.1A patent/CN104812392B/zh active Active
- 2013-11-29 BR BR112015012460-7A patent/BR112015012460B1/pt active IP Right Grant
- 2013-11-29 MX MX2015006325A patent/MX355461B/es active IP Right Grant
- 2013-11-29 JP JP2015544000A patent/JP5934448B2/ja active Active
- 2013-11-29 RU RU2015122023A patent/RU2620341C2/ru active
- 2013-11-29 WO PCT/KR2013/010967 patent/WO2014084651A1/en active Application Filing
-
2015
- 2015-04-22 PH PH12015500900A patent/PH12015500900B1/en unknown
- 2015-05-29 CL CL2015001461A patent/CL2015001461A1/es unknown
-
2016
- 2016-01-08 HK HK16100181.1A patent/HK1212224A1/xx unknown
Also Published As
| Publication number | Publication date |
|---|---|
| HK1212224A1 (en) | 2016-06-10 |
| US9265832B2 (en) | 2016-02-23 |
| CL2015001461A1 (es) | 2015-10-23 |
| JOP20130342B1 (ar) | 2021-08-17 |
| CN104812392A (zh) | 2015-07-29 |
| AR093645A1 (es) | 2015-06-17 |
| US20150297724A1 (en) | 2015-10-22 |
| MX2015006325A (es) | 2016-02-25 |
| BR112015012460A2 (ru) | 2017-08-22 |
| ES2656901T3 (es) | 2018-02-28 |
| MX355461B (es) | 2018-04-19 |
| EP2925325B1 (en) | 2017-11-01 |
| TW201434493A (zh) | 2014-09-16 |
| WO2014084651A1 (en) | 2014-06-05 |
| TWI498128B (zh) | 2015-09-01 |
| PH12015500900A1 (en) | 2015-07-06 |
| EP2925325A1 (en) | 2015-10-07 |
| RU2620341C2 (ru) | 2017-05-24 |
| CN104812392B (zh) | 2017-05-17 |
| KR101260636B1 (ko) | 2013-05-13 |
| JP2016500099A (ja) | 2016-01-07 |
| BR112015012460B1 (pt) | 2022-04-05 |
| PH12015500900B1 (en) | 2015-07-06 |
| EP2925325A4 (en) | 2016-07-13 |
| JP5934448B2 (ja) | 2016-06-15 |
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| PD4A | Correction of name of patent owner |