CN104812392B - 稳定的培美曲塞制剂 - Google Patents

稳定的培美曲塞制剂 Download PDF

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Publication number
CN104812392B
CN104812392B CN201380062109.1A CN201380062109A CN104812392B CN 104812392 B CN104812392 B CN 104812392B CN 201380062109 A CN201380062109 A CN 201380062109A CN 104812392 B CN104812392 B CN 104812392B
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CN
China
Prior art keywords
pemetrexed
formulation
formulations
acid
acetylcysteine
Prior art date
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Application number
CN201380062109.1A
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English (en)
Chinese (zh)
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CN104812392A (zh
Inventor
朴映准
申明珍
秦宏澈
崔河龙
崔洛铉
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HK Inno N Corp
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CJ Healthcare Corp
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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
    • A61K31/495—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
    • 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
    • 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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (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)
CN201380062109.1A 2012-11-29 2013-11-29 稳定的培美曲塞制剂 Active CN104812392B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020120137375A KR101260636B1 (ko) 2012-11-29 2012-11-29 안정화된 페메트렉시드 제제
KR10-2012-0137375 2012-11-29
PCT/KR2013/010967 WO2014084651A1 (en) 2012-11-29 2013-11-29 A stabilized pemetrexed formulation

Publications (2)

Publication Number Publication Date
CN104812392A CN104812392A (zh) 2015-07-29
CN104812392B true CN104812392B (zh) 2017-05-17

Family

ID=48665454

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380062109.1A Active CN104812392B (zh) 2012-11-29 2013-11-29 稳定的培美曲塞制剂

Country Status (15)

Country Link
US (1) US9265832B2 (enExample)
EP (1) EP2925325B1 (enExample)
JP (1) JP5934448B2 (enExample)
KR (1) KR101260636B1 (enExample)
CN (1) CN104812392B (enExample)
AR (1) AR093645A1 (enExample)
BR (1) BR112015012460B1 (enExample)
CL (1) CL2015001461A1 (enExample)
ES (1) ES2656901T3 (enExample)
JO (1) JOP20130342B1 (enExample)
MX (1) MX355461B (enExample)
PH (1) PH12015500900B1 (enExample)
RU (1) RU2620341C2 (enExample)
TW (1) TWI498128B (enExample)
WO (1) WO2014084651A1 (enExample)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
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
EP3040074B1 (en) * 2013-10-03 2018-07-25 Fujifilm Corporation Injection preparation and method for producing same
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
PL3124026T3 (pl) * 2014-03-28 2019-03-29 Fujifilm Corporation Preparat iniekcyjny i sposób jego wytwarzania
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
CN111093626A (zh) * 2017-08-29 2020-05-01 费森尤斯卡比肿瘤学有限公司 培美曲塞的稳定的液体组合物
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
EP4132504A1 (en) * 2020-04-09 2023-02-15 Emphascience, Inc. Methods of treatment using antifolates and pharmaceutical formulations comprising antifolates

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1396828A (zh) * 2000-02-04 2003-02-12 伊莱利利公司 含有培美西德以及一硫代甘油l－半胱氨酸或巯乙酸的药物组合物
US20090181990A1 (en) * 2007-12-23 2009-07-16 Patel Nileshkumar S Stable amorphous form of pemetrexed disodium
WO2012015810A2 (en) * 2010-07-28 2012-02-02 Eagle Pharmaceuticals, Inc. Pharmaceutical compositions containing pemetrexed having extended storage stability
WO2012121523A2 (en) * 2011-03-10 2012-09-13 Kuhnil Pharm. Co., Ltd. Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt

Family Cites Families (9)

* Cited by examiner, † Cited by third party
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
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.
SI1574221T1 (sl) 2004-03-10 2007-10-31 Shimoda Biotech Pty Ltd Stabilni sestavki diklofenaka za vbrizgavanje
DE602007011384D1 (de) * 2006-08-14 2011-02-03 Sicor Inc Verfahren zur herstellung lipophiler pharmazeutisch akzeptabler salze aus pemetrexed-disäure
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1396828A (zh) * 2000-02-04 2003-02-12 伊莱利利公司 含有培美西德以及一硫代甘油l－半胱氨酸或巯乙酸的药物组合物
US20090181990A1 (en) * 2007-12-23 2009-07-16 Patel Nileshkumar S Stable amorphous form of pemetrexed disodium
WO2012015810A2 (en) * 2010-07-28 2012-02-02 Eagle Pharmaceuticals, Inc. Pharmaceutical compositions containing pemetrexed having extended storage stability
WO2012121523A2 (en) * 2011-03-10 2012-09-13 Kuhnil Pharm. Co., Ltd. Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt

Also Published As

Publication number Publication date
TWI498128B (zh) 2015-09-01
CL2015001461A1 (es) 2015-10-23
KR101260636B1 (ko) 2013-05-13
MX2015006325A (es) 2016-02-25
EP2925325A4 (en) 2016-07-13
CN104812392A (zh) 2015-07-29
WO2014084651A1 (en) 2014-06-05
US20150297724A1 (en) 2015-10-22
JOP20130342B1 (ar) 2021-08-17
EP2925325B1 (en) 2017-11-01
US9265832B2 (en) 2016-02-23
ES2656901T3 (es) 2018-02-28
RU2620341C2 (ru) 2017-05-24
BR112015012460B1 (pt) 2022-04-05
JP5934448B2 (ja) 2016-06-15
MX355461B (es) 2018-04-19
PH12015500900A1 (en) 2015-07-06
AR093645A1 (es) 2015-06-17
HK1212224A1 (en) 2016-06-10
JP2016500099A (ja) 2016-01-07
TW201434493A (zh) 2014-09-16
RU2015122023A (ru) 2017-01-10
BR112015012460A2 (enExample) 2017-08-22
PH12015500900B1 (en) 2015-07-06
EP2925325A1 (en) 2015-10-07

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