DK4011377T3 - Intravenøs infusionsdoseringsform omfattende pemetrexed - Google Patents

Intravenøs infusionsdoseringsform omfattende pemetrexed Download PDF

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Publication number
DK4011377T3
DK4011377T3 DK22152673.4T DK22152673T DK4011377T3 DK 4011377 T3 DK4011377 T3 DK 4011377T3 DK 22152673 T DK22152673 T DK 22152673T DK 4011377 T3 DK4011377 T3 DK 4011377T3
Authority
DK
Denmark
Prior art keywords
dosage form
intravenous infusion
form containing
infusion dosage
containing pemetrexed
Prior art date
Application number
DK22152673.4T
Other languages
English (en)
Inventor
Samarth Kumar
Prashant Kane
Subhas Balaram Bhowmick
Kirti Ganorkar
Ramaji Karshanbhai Mistry
Ramaji Karshanbhai Varu
Original Assignee
Sun Pharmaceutical Ind Ltd
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 Sun Pharmaceutical Ind Ltd filed Critical Sun Pharmaceutical Ind Ltd
Application granted granted Critical
Publication of DK4011377T3 publication Critical patent/DK4011377T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • 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
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/10Inactivation or decontamination of a medicinal preparation prior to administration to an animal or a person
    • 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
    • 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02Sterilising, e.g. of complete packages
    • B65B55/04Sterilising wrappers or receptacles prior to, or during, packaging
    • B65B55/06Sterilising wrappers or receptacles prior to, or during, packaging by heat
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00Closing containers or receptacles after filling
    • B65B7/02Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
DK22152673.4T 2015-02-13 2016-02-12 Intravenøs infusionsdoseringsform omfattende pemetrexed DK4011377T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN473MU2015 2015-02-13
EP16748851.9A EP3256133B1 (en) 2015-02-13 2016-02-12 Intravenous infusion dosage form

Publications (1)

Publication Number Publication Date
DK4011377T3 true DK4011377T3 (da) 2025-01-20

Family

ID=56614469

Family Applications (2)

Application Number Title Priority Date Filing Date
DK16748851.9T DK3256133T3 (da) 2015-02-13 2016-02-12 Intravenøs infusionsdoseringsform
DK22152673.4T DK4011377T3 (da) 2015-02-13 2016-02-12 Intravenøs infusionsdoseringsform omfattende pemetrexed

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK16748851.9T DK3256133T3 (da) 2015-02-13 2016-02-12 Intravenøs infusionsdoseringsform

Country Status (8)

Country Link
US (2) US10869867B2 (da)
EP (2) EP3256133B1 (da)
JP (3) JP6869899B2 (da)
DK (2) DK3256133T3 (da)
ES (2) ES2928018T3 (da)
FI (1) FI4011377T3 (da)
PL (1) PL4011377T3 (da)
WO (1) WO2016129000A1 (da)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2015326037A1 (en) * 2014-10-02 2017-04-13 Terumo Kabushiki Kaisha Medical container for accommodating protein solution preparation therein
JP6869899B2 (ja) * 2015-02-13 2021-05-12 サン・ファーマシューティカル・インダストリーズ・リミテッド 静脈内注入剤形
US20170239250A1 (en) 2016-02-19 2017-08-24 Eagle Pharmaceuticals, Inc. Pemetrexed formulations
US10373530B2 (en) * 2017-07-31 2019-08-06 Pharmedium Services, Llc Intravenous bag and line label
ES2959975T3 (es) * 2017-10-10 2024-02-29 Sun Pharmaceutical Ind Ltd Forma de dosificación para infusión intravenosa de pemetrexed
JP2019123684A (ja) * 2018-01-15 2019-07-25 日本化薬株式会社 ペメトレキセドを含有する注射用溶液製剤
JPWO2019244965A1 (ja) * 2018-06-20 2020-06-25 日本化薬株式会社 ペメトレキセドナトリウム注射用溶液製剤、並びにその製造方法
EP4114336A1 (en) 2020-03-06 2023-01-11 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
EP4288078A4 (en) * 2021-02-03 2024-12-11 Sun Pharmaceutical Industries Ltd READY-TO-USE OXYTOCIN DOSAGE FORM

Family Cites Families (22)

* Cited by examiner, † Cited by third party
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US6686365B2 (en) 2000-02-04 2004-02-03 Eli Lilly And Company Pharmaceutical composition
US6476068B1 (en) * 2001-12-06 2002-11-05 Pharmacia Italia, S.P.A. Platinum derivative pharmaceutical formulations
JP4956942B2 (ja) 2004-09-15 2012-06-20 ニプロ株式会社 安定化された注射用水溶液製剤
US20090105684A1 (en) * 2007-10-23 2009-04-23 Baxter International Inc. Medication port for medical fluid container
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
JP2012188397A (ja) * 2011-03-11 2012-10-04 Terumo Corp モルヒネ塩酸塩注射液製剤包装体
US20140296176A1 (en) * 2011-08-19 2014-10-02 Synta Pharmaceuticals Corp. Combination cancer therapy with an hsp90 inhibitor and an antimetabolite
US20150073000A1 (en) * 2012-03-27 2015-03-12 Fresenius Kabi Oncology Limited Stable ready-to-use pharmaceutical composition of pemetrexed
KR20130122065A (ko) 2012-04-30 2013-11-07 씨제이제일제당 (주) 페메트렉시드를 함유하는 안정화된 주사용 액상 제제
EP2666463A1 (en) 2012-05-21 2013-11-27 Synthon BV Stabilized liquid composition comprising pemetrexed
EP3210629A1 (en) * 2012-05-30 2017-08-30 Fresenius Kabi Oncology Ltd Pharmaceutical composition of pemetrexed
WO2013179310A1 (en) 2012-05-31 2013-12-05 Mylan Laboratories Limited Stable aqueous compositions of pemetrexed
US20140303254A1 (en) * 2013-04-08 2014-10-09 InnoPharma Licensing LLC Process Of Manufacturing A Stable, Ready To Use Infusion Bag For An Oxidation Sensitive Formulation
KR101485243B1 (ko) 2013-05-08 2015-01-21 씨제이헬스케어 주식회사 안정화된 페메트렉시드 제제
JP6152338B2 (ja) * 2013-05-10 2017-06-21 株式会社Okiデータ・インフォテック 記録装置および組み立て方法
TW201536348A (zh) * 2013-07-15 2015-10-01 Alchemia Oncology Pty Ltd 預製備藥物以用於醫療用途的方法
WO2015092758A1 (en) * 2013-12-19 2015-06-25 Dr. Reddy' S Laboratories Ltd Liquid pharmaceutical formulations of pemetrexed
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
JP6099810B2 (ja) 2014-03-28 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
US10098813B2 (en) * 2014-09-03 2018-10-16 Sun Pharmaceutical Industries Limited Perfusion dosage form
JP6869899B2 (ja) * 2015-02-13 2021-05-12 サン・ファーマシューティカル・インダストリーズ・リミテッド 静脈内注入剤形

Also Published As

Publication number Publication date
ES3007633T3 (en) 2025-03-20
EP3256133A4 (en) 2018-08-01
ES2928018T3 (es) 2022-11-15
US10869867B2 (en) 2020-12-22
PL4011377T3 (pl) 2025-03-03
JP2022180486A (ja) 2022-12-06
US20180036310A1 (en) 2018-02-08
JP2018508575A (ja) 2018-03-29
EP4011377A1 (en) 2022-06-15
EP4011377B1 (en) 2024-10-23
JP6869899B2 (ja) 2021-05-12
JP2021035969A (ja) 2021-03-04
FI4011377T3 (fi) 2025-01-07
WO2016129000A1 (en) 2016-08-18
US20210128562A1 (en) 2021-05-06
EP3256133A1 (en) 2017-12-20
US12403070B2 (en) 2025-09-02
DK3256133T3 (da) 2022-10-24
EP3256133B1 (en) 2022-08-17

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