AR119655A1 - Soluciones de complejos de radionúclidos estables y concentradas - Google Patents

Soluciones de complejos de radionúclidos estables y concentradas

Info

Publication number
AR119655A1
AR119655A1 ARP190102070A ARP190102070A AR119655A1 AR 119655 A1 AR119655 A1 AR 119655A1 AR P190102070 A ARP190102070 A AR P190102070A AR P190102070 A ARP190102070 A AR P190102070A AR 119655 A1 AR119655 A1 AR 119655A1
Authority
AR
Argentina
Prior art keywords
stabilizers
radionuclide
present
concentration
stable
Prior art date
Application number
ARP190102070A
Other languages
English (en)
Original Assignee
Advanced Accelerator Applications S A
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 Advanced Accelerator Applications S A filed Critical Advanced Accelerator Applications S A
Publication of AR119655A1 publication Critical patent/AR119655A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/083—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins the peptide being octreotide or a somatostatin-receptor-binding peptide
    • 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
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/08—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/088—Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins conjugates with carriers being peptides, polyamino acids or proteins
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente se refiere a soluciones de complejos de radionúclidos de alta concentración y de alta estabilidad química, que permiten su uso como producto farmacéutico para fines de diagnóstico y/o terapéuticos. La estabilidad del producto farmacéutico se logra mediante por lo menos un estabilizador contra la degradación radiolítica. Se encontró que el uso de dos estabilizadores introducidos durante el proceso de fabricación en diferentes etapas fue una ventaja particular. Reivindicación 1: Una solución acuosa farmacéutica que comprende: (a) un complejo formado por (ai) el radionúclido ¹⁷⁷Lu (Lutecio-177), y (aii) un péptido de unión al receptor de somatostatina unido al agente quelante DOTA; y (b) por lo menos dos diferentes estabilizadores contra la degradación radiolítica; donde: dicho radionúclido se presenta en una concentración de manera tal que proporciona una radiactividad volumétrica de 250 a 500 MBq/mL; y dichos estabilizadores se presentan en una concentración total de 0,2 a 20,0 mg/mL. Reivindicación 2: La solución acuosa farmacéutica de acuerdo con la reivindicación 1, donde dicho componente (b) comprende los estabilizadores: (bi) ácido gentísico o una de sus sales; y (bii) ácido ascórbico o una de sus sales.
ARP190102070A 2018-07-25 2019-07-23 Soluciones de complejos de radionúclidos estables y concentradas AR119655A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/055575 WO2020021310A1 (en) 2018-07-25 2018-07-25 Stable, concentrated radionuclide complex solutions

Publications (1)

Publication Number Publication Date
AR119655A1 true AR119655A1 (es) 2022-01-05

Family

ID=63371737

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP190102070A AR119655A1 (es) 2018-07-25 2019-07-23 Soluciones de complejos de radionúclidos estables y concentradas

Country Status (3)

Country Link
JP (2) JP7358451B2 (es)
AR (1) AR119655A1 (es)
WO (1) WO2020021310A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11541134B1 (en) 2021-08-02 2023-01-03 Rayzebio, Inc. Stabilized compositions of radionuclides and uses thereof
WO2023148680A1 (en) * 2022-02-04 2023-08-10 Advanced Accelerator Applications Methods for large scale synthesis of radionuclide complexes
WO2023202730A2 (zh) * 2022-04-20 2023-10-26 北京先通国际医药科技股份有限公司 放射性伊文思蓝衍生物药物水溶液及其制备方法和用途
CN117159753A (zh) * 2022-04-20 2023-12-05 北京先通国际医药科技股份有限公司 放射性标记的伊文思蓝衍生物药物的制备方法及用途

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2526556C (en) * 2003-07-24 2012-09-25 Bracco Imaging S.P.A. Stable radiopharmaceutical compositions and methods for their preparation
WO2008009444A1 (en) * 2006-07-19 2008-01-24 Van Dulmen, Adrianus, A. Use of ethanol for stabilizing a single-vial liquid formulation of a radiolabeled peptide
KR102484725B1 (ko) * 2016-11-04 2023-01-06 클라리티 파마슈티컬스 리미티드 방사선 요법 및 진단 영상용 제형

Also Published As

Publication number Publication date
WO2020021310A1 (en) 2020-01-30
JP2023126209A (ja) 2023-09-07
JP2022500355A (ja) 2022-01-04
JP7358451B2 (ja) 2023-10-10

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