JP2024518046A - 無菌水性コリン塩組成物 - Google Patents

無菌水性コリン塩組成物 Download PDF

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Publication number
JP2024518046A
JP2024518046A JP2023566927A JP2023566927A JP2024518046A JP 2024518046 A JP2024518046 A JP 2024518046A JP 2023566927 A JP2023566927 A JP 2023566927A JP 2023566927 A JP2023566927 A JP 2023566927A JP 2024518046 A JP2024518046 A JP 2024518046A
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JP
Japan
Prior art keywords
composition
choline
choline chloride
gamma irradiation
subject
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.)
Pending
Application number
JP2023566927A
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English (en)
Japanese (ja)
Other versions
JP2024518046A5 (enExample
Inventor
リアダン，デイトン
ズモ，ジャクリーン
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.)
Protara Therapeutics Inc
Original Assignee
Protara Therapeutics 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
Priority claimed from US17/246,438 external-priority patent/US11311503B1/en
Application filed by Protara Therapeutics Inc filed Critical Protara Therapeutics Inc
Publication of JP2024518046A publication Critical patent/JP2024518046A/ja
Publication of JP2024518046A5 publication Critical patent/JP2024518046A5/ja
Pending legal-status Critical Current

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    • 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
    • A61K31/13—Amines
    • A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
    • 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
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1493—Containers with shape retaining means, e.g. to support the structure of the container during emptying or filling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
JP2023566927A 2021-04-29 2022-04-28 無菌水性コリン塩組成物 Pending JP2024518046A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202163181858P 2021-04-29 2021-04-29
US63/181,858 2021-04-29
US17/246,438 2021-04-30
US17/246,438 US11311503B1 (en) 2021-04-29 2021-04-30 Sterile aqueous choline salt compositions
US17/672,549 US12083081B2 (en) 2021-04-29 2022-02-15 Sterile aqueous choline salt compositions
US17/672,549 2022-02-15
PCT/US2022/026693 WO2022232371A1 (en) 2021-04-29 2022-04-28 Sterile aqueous choline salt compositions

Publications (2)

Publication Number Publication Date
JP2024518046A true JP2024518046A (ja) 2024-04-24
JP2024518046A5 JP2024518046A5 (enExample) 2025-04-15

Family

ID=83848827

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023566927A Pending JP2024518046A (ja) 2021-04-29 2022-04-28 無菌水性コリン塩組成物

Country Status (6)

Country Link
US (1) US12083081B2 (enExample)
EP (1) EP4329723A4 (enExample)
JP (1) JP2024518046A (enExample)
CA (1) CA3214381A1 (enExample)
IL (1) IL307786A (enExample)
WO (1) WO2022232371A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4696313A1 (en) * 2024-08-13 2026-02-18 WÖRWAG Pharma GmbH & Co.KG Formulation of krill oil and silymarin

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002338463A (ja) * 2001-05-23 2002-11-27 Terumo Corp コリン配合輸液剤
JP2009505987A (ja) * 2005-08-16 2009-02-12 アラン・エル ブックマン， 完全非経口栄養法に伴う血栓症を予防するためのコリンの使用
JP2015067559A (ja) * 2013-09-27 2015-04-13 テルモ株式会社 鉄代謝改善輸液剤
JP2016179965A (ja) * 2015-03-25 2016-10-13 テルモ株式会社 ヘプシジン−２５産生抑制剤

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994009769A1 (en) * 1992-11-02 1994-05-11 Buchman Alan L Use of choline in total parenteral nutrition
US20110028548A1 (en) 2004-04-19 2011-02-03 Strategic Science & Technologies, Llc Beneficial effects of increasing local blood flow
US7902145B2 (en) 2005-05-19 2011-03-08 Albiorex, Llc Terminal sterilization of injectable collagen products
WO2008066899A2 (en) 2006-11-28 2008-06-05 Marinus Pharmaceuticals Nanoparticulate formulations and methods for the making and use thereof
CA2680106A1 (en) 2007-03-23 2008-10-02 H. William Bosch Gamma radiation sterilized nanoparticulate docetaxel compositions and methods for making the same
US20210212936A1 (en) 2018-06-01 2021-07-15 Baxter International Inc. Parenteral nutrition formulation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002338463A (ja) * 2001-05-23 2002-11-27 Terumo Corp コリン配合輸液剤
JP2009505987A (ja) * 2005-08-16 2009-02-12 アラン・エル ブックマン， 完全非経口栄養法に伴う血栓症を予防するためのコリンの使用
JP2015067559A (ja) * 2013-09-27 2015-04-13 テルモ株式会社 鉄代謝改善輸液剤
JP2016179965A (ja) * 2015-03-25 2016-10-13 テルモ株式会社 ヘプシジン−２５産生抑制剤

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
"ヘルスケア製品の滅菌-放射線-第1部：医療機器の滅菌プロセスの開発， バリデーション及び日常管理の要求事", KIKAKURUI.COM, JPN7026000236, 2015, ISSN: 0005903305 *
F. HASANAIN ET AL.: "Gamma Sterilization of Pharmaceuticals--A Review of the Irradiation of Excipients, Active Pharmaceut", PDA JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, vol. 68, no. 2, JPN6026028301, 2014, pages 113 - 137, ISSN: 0005903308 *
JACOBS, G. P.: "Validation of the Radiation Sterilization of Pharmaceuticals", HANDBOOK OF VALIDATION I PHARMACEUTICAL PROCESSES, THIRD EDITION, JPN6026028300, 2007, pages 269 - 275, ISSN: 0005903307 *
医療用具の放射線滅菌についての規格基準, JPN7026000235, 1999, ISSN: 0005903304 *
宝月 大輔: "滅菌を主目的とした医薬用物質の放射線照射に関するレヴュー", 一般財団法人 量子放射線利用振興協会 ホームページ[ONLINE], JPN6026028299, 1996, ISSN: 0005903306 *
最終滅菌法による無菌医薬品の製造に関する指針, JPN7026000234, 2012, ISSN: 0005903303 *

Also Published As

Publication number Publication date
EP4329723A4 (en) 2025-03-26
US12083081B2 (en) 2024-09-10
US20230024844A1 (en) 2023-01-26
IL307786A (en) 2023-12-01
EP4329723A1 (en) 2024-03-06
WO2022232371A1 (en) 2022-11-03
CA3214381A1 (en) 2022-11-03

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