CA3214381A1 - Sterile aqueous choline salt compositions - Google Patents

Sterile aqueous choline salt compositions Download PDF

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Publication number
CA3214381A1
CA3214381A1 CA3214381A CA3214381A CA3214381A1 CA 3214381 A1 CA3214381 A1 CA 3214381A1 CA 3214381 A CA3214381 A CA 3214381A CA 3214381 A CA3214381 A CA 3214381A CA 3214381 A1 CA3214381 A1 CA 3214381A1
Authority
CA
Canada
Prior art keywords
composition
choline
choline chloride
drug product
gamma irradiation
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
CA3214381A
Other languages
English (en)
French (fr)
Inventor
Dayton Reardan
Jacqueline Zummo
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 CA3214381A1 publication Critical patent/CA3214381A1/en
Pending legal-status Critical Current

Links

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
    • A61K31/13—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)
CA3214381A 2021-04-29 2022-04-28 Sterile aqueous choline salt compositions Pending CA3214381A1 (en)

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 US11311503B1 (en) 2021-04-29 2021-04-30 Sterile aqueous choline salt compositions
US17/246,438 2021-04-30
US17/672,549 2022-02-15
US17/672,549 US12083081B2 (en) 2021-04-29 2022-02-15 Sterile aqueous choline salt compositions
PCT/US2022/026693 WO2022232371A1 (en) 2021-04-29 2022-04-28 Sterile aqueous choline salt compositions

Publications (1)

Publication Number Publication Date
CA3214381A1 true CA3214381A1 (en) 2022-11-03

Family

ID=83848827

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3214381A Pending CA3214381A1 (en) 2021-04-29 2022-04-28 Sterile aqueous choline salt compositions

Country Status (6)

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

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

Family Cites Families (10)

* 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
JP5065555B2 (ja) * 2001-05-23 2012-11-07 テルモ株式会社 コリン配合輸液剤
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
CA2619145A1 (en) * 2005-08-16 2007-02-22 Alan L. Buchman Use of choline to prevent thrombosis associated with total parenteral nutrition
BRPI0717721A2 (pt) 2006-11-28 2013-10-29 Marinus Pharmaceuticals "partículas complexadas de drogas, composição farmacêutica, uso de uma composição farmacêutica, partículas complexadas de droga estabilizadas no tamanho, método para a preparação de partículas estabilizadas da droga, composição farmacêutica sólida, comprimido oral ingerível e composição líquida em nanopartículas estabilizadas no tamanho"
WO2008118754A2 (en) 2007-03-23 2008-10-02 Elan Corporation Plc Gamma radiation sterilized nanoparticulate docetaxel compositions and methods for making the same
JP6169458B2 (ja) * 2013-09-27 2017-07-26 テルモ株式会社 鉄代謝改善用輸液剤
JP6646309B2 (ja) * 2015-03-25 2020-02-14 テルモ株式会社 ヘプシジン−２５産生抑制剤
US20210212936A1 (en) 2018-06-01 2021-07-15 Baxter International Inc. Parenteral nutrition formulation

Also Published As

Publication number Publication date
US20230024844A1 (en) 2023-01-26
WO2022232371A1 (en) 2022-11-03
EP4329723A1 (en) 2024-03-06
EP4329723A4 (en) 2025-03-26
JP2024518046A (ja) 2024-04-24
US12083081B2 (en) 2024-09-10
IL307786A (en) 2023-12-01

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