MX362807B - Formulacion estabilizada de pemetrexed. - Google Patents

Formulacion estabilizada de pemetrexed.

Info

Publication number
MX362807B
MX362807B MX2015015356A MX2015015356A MX362807B MX 362807 B MX362807 B MX 362807B MX 2015015356 A MX2015015356 A MX 2015015356A MX 2015015356 A MX2015015356 A MX 2015015356A MX 362807 B MX362807 B MX 362807B
Authority
MX
Mexico
Prior art keywords
stabilized
pemetrexed preparation
pemetrexed
preparation
stabilized pemetrexed
Prior art date
Application number
MX2015015356A
Other languages
English (en)
Other versions
MX2015015356A (es
Inventor
Young Joon Park
Myung Jin Shin
Hong Chul Jin
Ha Yong Choi
Nak Hyun Choi
Original Assignee
Cj Healthcare Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51867494&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX362807(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cj Healthcare Corp filed Critical Cj Healthcare Corp
Publication of MX2015015356A publication Critical patent/MX2015015356A/es
Publication of MX362807B publication Critical patent/MX362807B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/517Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)

Abstract

La presente invención se refiere a una formulación estabilizada de pemetrexed y, más específicamente, a una formulación estabilizada de pemetrexed que contiene acetilcisteína como antioxidante y citrato sódico como agente tampón. Adicionalmente, la presente invención se refiere a una formulación de pemetrexed cargada en un recipiente sellado, que comprende pemetrexed o una sal farmacéuticamente aceptable del mismo como principio activo, en donde el contenido de oxígeno dentro del espacio aéreo del recipiente es del 3 % v/v/ o menor.
MX2015015356A 2013-05-08 2014-05-08 Formulacion estabilizada de pemetrexed. MX362807B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20130052083A KR101485243B1 (ko) 2013-05-08 2013-05-08 안정화된 페메트렉시드 제제
PCT/KR2014/004105 WO2014182093A1 (ko) 2013-05-08 2014-05-08 안정화된 페메트렉시드 제제

Publications (2)

Publication Number Publication Date
MX2015015356A MX2015015356A (es) 2016-03-04
MX362807B true MX362807B (es) 2019-02-13

Family

ID=51867494

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015015356A MX362807B (es) 2013-05-08 2014-05-08 Formulacion estabilizada de pemetrexed.

Country Status (13)

Country Link
US (1) US9629844B2 (es)
EP (1) EP2995298B1 (es)
JP (1) JP6159879B2 (es)
KR (1) KR101485243B1 (es)
CN (1) CN105451717B (es)
BR (1) BR112015028124B1 (es)
CL (1) CL2015003266A1 (es)
ES (1) ES2890523T3 (es)
HK (1) HK1218076A1 (es)
MX (1) MX362807B (es)
PH (1) PH12015502542B1 (es)
RU (1) RU2636783C2 (es)
WO (1) WO2014182093A1 (es)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101260636B1 (ko) * 2012-11-29 2013-05-13 씨제이제일제당 (주) 안정화된 페메트렉시드 제제
CN105611932B (zh) 2013-10-03 2019-02-12 富士胶片株式会社 注射液制剂及其制造方法
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
KR101770605B1 (ko) * 2014-11-17 2017-08-23 동아에스티 주식회사 페메트렉시드 또는 그것의 약제학적으로 허용가능 한 염을 함유하는 안정한 약제학적 조성물
WO2016082714A1 (zh) * 2014-11-26 2016-06-02 台湾东洋药品工业股份有限公司 具有长期稳定性的不含抗氧化剂的药物注射溶液的制备方法
FI4011377T3 (fi) 2015-02-13 2025-01-07 Sun Pharmaceutical Ind Ltd Suonensisäinen infuusioannosmuoto sisältäen pemetreksediä
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
US10507165B2 (en) 2017-05-31 2019-12-17 Adienne Pharma & Biotech Sa Multi chamber flexible bag and methods of using same
US10369077B2 (en) * 2017-05-31 2019-08-06 Adienne Pharma & Biotech Sa Multi chamber flexible bag and methods of using the same
EP3675819B1 (en) * 2017-08-29 2026-01-14 Fresenius Kabi Oncology Limited Stable liquid compositions of pemetrexed
AU2019378874B2 (en) * 2018-11-14 2025-05-29 Avm Biotechnology, Llc Stable glucocorticoid formulation
WO2021192471A1 (ja) * 2020-03-24 2021-09-30 ナガセ医薬品株式会社 ペメトレキセド製剤
TW202412808A (zh) * 2022-06-09 2024-04-01 大陸商上海雲晟研新生物科技有限公司 培美曲塞二鈉液體組合物、其製備方法及用途

Family Cites Families (13)

* 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
JP2003521518A (ja) * 2000-02-04 2003-07-15 イーライ・リリー・アンド・カンパニー モノチオグリセロール、l−システインまたはチオグリコール酸とともにペメトレクストを含む医薬組成物
WO2001062760A2 (en) 2000-02-25 2001-08-30 Eli Lilly And Company A NOVEL CRYSTALLINE FORM OF N-[4-[2-(2-AMINO-4,7-DIHYDRO-4-OXO-3H-PYRROLO[2,3-d]PYRIMIDIN-5-YL)ETHYL]BENZOYL]-L-GLUTAMIC ACID AND PROCESS THEREFOR
KR100774366B1 (ko) 2001-09-10 2007-11-08 주식회사 중외제약 파클리탁셀 주사제 조성물
JP2007528384A (ja) 2004-03-10 2007-10-11 シモダ、バイオテック(プロプライエタリー)リミテッド 安定な注射可能なジクロフェナク組成物
EP2072518A1 (en) * 2007-12-23 2009-06-24 Sun Pharma Advanced Research Company Limited Stable Amorphous Form of Pemextred Disodium
WO2010030598A2 (en) * 2008-09-11 2010-03-18 Dr. Reddy's Laboratories Limited Pharmaceutical formulations comprising pemetrexed
US9655898B2 (en) * 2010-07-28 2017-05-23 Eagle Pharmaceuticals, Inc. Pharmaceutical compositions containing pemetrexed having extended storage stability
KR101069128B1 (ko) 2011-03-10 2011-09-30 건일제약 주식회사 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법
SI2854768T1 (sl) 2012-05-30 2017-08-31 Fresenius Kabi Oncology Limited Farmacevtski sestavki pemetrekseda
KR101260636B1 (ko) * 2012-11-29 2013-05-13 씨제이제일제당 (주) 안정화된 페메트렉시드 제제

Also Published As

Publication number Publication date
RU2636783C2 (ru) 2017-11-28
KR101485243B1 (ko) 2015-01-21
CN105451717B (zh) 2018-05-22
EP2995298A1 (en) 2016-03-16
CL2015003266A1 (es) 2016-04-22
US20160120867A1 (en) 2016-05-05
CN105451717A (zh) 2016-03-30
JP2016518404A (ja) 2016-06-23
RU2015149114A (ru) 2017-06-09
EP2995298B1 (en) 2021-06-23
HK1218076A1 (zh) 2017-02-03
BR112015028124A2 (pt) 2017-07-25
MX2015015356A (es) 2016-03-04
EP2995298A4 (en) 2017-01-25
KR20140132621A (ko) 2014-11-18
ES2890523T3 (es) 2022-01-20
PH12015502542B1 (en) 2019-11-15
JP6159879B2 (ja) 2017-07-05
US9629844B2 (en) 2017-04-25
BR112015028124B1 (pt) 2023-02-28
WO2014182093A1 (ko) 2014-11-13
PH12015502542A1 (en) 2016-02-22

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