CA3014755A1 - Formulations de pemetrexed stables comprenant du propyleneglycol - Google Patents

Formulations de pemetrexed stables comprenant du propyleneglycol Download PDF

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Publication number
CA3014755A1
CA3014755A1 CA3014755A CA3014755A CA3014755A1 CA 3014755 A1 CA3014755 A1 CA 3014755A1 CA 3014755 A CA3014755 A CA 3014755A CA 3014755 A CA3014755 A CA 3014755A CA 3014755 A1 CA3014755 A1 CA 3014755A1
Authority
CA
Canada
Prior art keywords
pemetrexed
pharmaceutical composition
storage
concentration
months
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.)
Granted
Application number
CA3014755A
Other languages
English (en)
Other versions
CA3014755C (fr
Inventor
Feng-Jing Chen
Steven L. Krill
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eagle Pharmaceuticals Inc
Original Assignee
Eagle Pharmaceuticals Inc
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
Application filed by Eagle Pharmaceuticals Inc filed Critical Eagle Pharmaceuticals Inc
Publication of CA3014755A1 publication Critical patent/CA3014755A1/fr
Application granted granted Critical
Publication of CA3014755C publication Critical patent/CA3014755C/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16—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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Abstract

La présente invention concerne des formulations de pémétrexed comprenant un solvant non aqueux qui reste stable après dilution pendant au moins environ 48 heures en cas de stockage à 2 à 8 °C. La présente invention concerne également des formulations de pémétrexed comprenant un solvant non aqueux qui reste stable pendant au moins environ 24 mois en cas de stockage à 2 à 8 °C.
CA3014755A 2016-02-19 2016-02-19 Formulations de pemetrexed stables comprenant du propyleneglycol Active CA3014755C (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2016/018703 WO2017142556A1 (fr) 2016-02-19 2016-02-19 Formulations de pémétrexed

Publications (2)

Publication Number Publication Date
CA3014755A1 true CA3014755A1 (fr) 2017-08-24
CA3014755C CA3014755C (fr) 2023-11-14

Family

ID=59625349

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3014755A Active CA3014755C (fr) 2016-02-19 2016-02-19 Formulations de pemetrexed stables comprenant du propyleneglycol

Country Status (9)

Country Link
EP (1) EP3416646A4 (fr)
JP (1) JP2019505561A (fr)
KR (2) KR20180132643A (fr)
CN (1) CN109152778B (fr)
AU (2) AU2016393213B2 (fr)
CA (1) CA3014755C (fr)
IL (3) IL301291A (fr)
MX (2) MX2018010037A (fr)
WO (1) WO2017142556A1 (fr)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6686365B2 (en) * 2000-02-04 2004-02-03 Eli Lilly And Company Pharmaceutical composition
US8629152B2 (en) * 2006-08-14 2014-01-14 Sicor, Inc. Processes for the preparation of lyophilized pharmaceutically acceptable salts of pemetrexed diacid
WO2012015810A2 (fr) * 2010-07-28 2012-02-02 Eagle Pharmaceuticals, Inc. Compositions pharmaceutiques contenant du pemetrexed présentant une stabilité en stockage prolongé
IN2012DE00912A (fr) * 2012-03-27 2015-09-11 Fresenius Kabi Oncology Ltd
EP2666463A1 (fr) * 2012-05-21 2013-11-27 Synthon BV Composition liquide stabilisée comprenant du pemetrexed
SI2854768T1 (sl) * 2012-05-30 2017-08-31 Fresenius Kabi Oncology Limited Farmacevtski sestavki pemetrekseda
WO2013179310A1 (fr) * 2012-05-31 2013-12-05 Mylan Laboratories Limited Compositions aqueuses stables de pémétrexed
JP6099557B2 (ja) * 2013-12-27 2017-03-22 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
PL3206666T3 (pl) * 2014-10-16 2020-09-21 Synthon B.V. Ciekła kompozycja farmaceutyczna zawierająca pemetreksed

Also Published As

Publication number Publication date
IL261179A (en) 2018-10-31
KR20240049356A (ko) 2024-04-16
WO2017142556A1 (fr) 2017-08-24
JP2019505561A (ja) 2019-02-28
IL290647A (en) 2022-04-01
IL301291A (en) 2023-05-01
EP3416646A1 (fr) 2018-12-26
AU2023202089A1 (en) 2023-06-01
MX2022009547A (es) 2022-09-09
CA3014755C (fr) 2023-11-14
EP3416646A4 (fr) 2019-09-04
IL290647B1 (en) 2023-04-01
CN109152778A (zh) 2019-01-04
AU2016393213B2 (en) 2022-03-31
KR20180132643A (ko) 2018-12-12
CN109152778B (zh) 2021-08-10
MX2018010037A (es) 2019-07-04
IL290647B2 (en) 2023-08-01
IL261179B (en) 2022-03-01
AU2016393213A1 (en) 2018-10-04

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