AR119974A1 - Composición radiofarmacéutica concentrada, estable - Google Patents

Composición radiofarmacéutica concentrada, estable

Info

Publication number
AR119974A1
AR119974A1 ARP200102561A ARP200102561A AR119974A1 AR 119974 A1 AR119974 A1 AR 119974A1 AR P200102561 A ARP200102561 A AR P200102561A AR P200102561 A ARP200102561 A AR P200102561A AR 119974 A1 AR119974 A1 AR 119974A1
Authority
AR
Argentina
Prior art keywords
radionuclide
salts
optionally
pharmaceutical composition
complex formed
Prior art date
Application number
ARP200102561A
Other languages
English (en)
Inventor
Maurizio F Mariani
Francesca Orlandi
Lorenza Fugazza
Lorenzo Sacchetti
Mattia Tedesco
Donato Barbato
Original Assignee
Advanced Accelerator Applications Italy Srl
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 Italy Srl filed Critical Advanced Accelerator Applications Italy Srl
Publication of AR119974A1 publication Critical patent/AR119974A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations 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
    • A61K51/04Organic compounds
    • A61K51/08Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/088Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins conjugates with carriers being peptides, polyamino acids or proteins
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/121Solutions, i.e. homogeneous liquid formulation

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)
  • Dispersion Chemistry (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 descripción se relaciona con soluciones de complejos de radionucleidos de elevada concentración y de elevada estabilidad química, que permite su uso como producto de droga para propósitos de diagnóstico y/o terapéuticos. La estabilidad del producto de droga es lograda mediante al menos un estabilizante contra la degradación radiolítica. Se halló particularmente ventajoso el uso de dos estabilizantes introducidos durante el proceso de fabricación en diferentes etapas. Reivindicación 1: Una composición farmacéutica que comprende: (a) un complejo formado por (ai) un radionucleido, y (aii) una fracción molecular peptídica de unión antagonista al receptor del péptido liberador de gastrina ligada a un agente quelante; y; (b) al menos dos estabilizadores contra la degradación radiolítica; y (c) opcionalmente un surfactante. Reivindicación 13: Una composición farmacéutica que comprende: (a) un complejo formado por (ai) el radionucleido ¹⁷⁷Lutecio (Lu-177), y (aii) NeoB de la fórmula (1); y; (b) ácido gentísico o sales del mismo y ácido ascórbico o sales del mismo; (c) opcionalmente, Hidroxiestearato de Macrogol 15, (d) opcionalmente, al menos un otro excipiente farmacéuticamente aceptable. Reivindicación 15: Una composición farmacéutica que consiste en: (a) un complejo formado por (ai) radionucleido ¹⁷⁷Lutecio (Lu-177), y (a2) NeoB de la fórmula (1); y; (b) ácido gentísico o sales del mismo y ácido ascórbico o sales del mismo; (c) Hidroxiestearato de Macrogol 15; (d) buffer acetato; (e) agua para inyección, y (f) NaOH, (g) DTPA.
ARP200102561A 2019-09-16 2020-09-15 Composición radiofarmacéutica concentrada, estable AR119974A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP19197607 2019-09-16

Publications (1)

Publication Number Publication Date
AR119974A1 true AR119974A1 (es) 2022-01-26

Family

ID=67981980

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP200102561A AR119974A1 (es) 2019-09-16 2020-09-15 Composición radiofarmacéutica concentrada, estable

Country Status (11)

Country Link
US (1) US20220401593A1 (es)
EP (1) EP4031193A1 (es)
JP (1) JP2022548875A (es)
KR (1) KR20220063218A (es)
CN (1) CN114728088A (es)
AR (1) AR119974A1 (es)
AU (1) AU2020349002B2 (es)
CA (1) CA3154302A1 (es)
IL (1) IL291315A (es)
TW (1) TW202123976A (es)
WO (1) WO2021052960A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023100852A1 (ja) * 2021-11-30 2023-06-08 日本メジフィジックス株式会社 安定化放射性医薬組成物
CN114404619A (zh) * 2022-03-28 2022-04-29 北京先通国际医药科技股份有限公司 放射性药物水溶液及其制备方法和用途
CN114404618A (zh) * 2022-03-28 2022-04-29 北京先通国际医药科技股份有限公司 放射性药物水溶液及其用途

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
EP3536347A1 (en) * 2012-09-25 2019-09-11 Advanced Accelerator Applications USA, Inc. Grpr-antagonists for detection, diagnosis and treatment of grpr-positive cancer

Also Published As

Publication number Publication date
WO2021052960A1 (en) 2021-03-25
EP4031193A1 (en) 2022-07-27
AU2020349002A1 (en) 2022-04-28
US20220401593A1 (en) 2022-12-22
AU2020349002B2 (en) 2024-05-02
JP2022548875A (ja) 2022-11-22
IL291315A (en) 2022-05-01
KR20220063218A (ko) 2022-05-17
TW202123976A (zh) 2021-07-01
CN114728088A (zh) 2022-07-08
CA3154302A1 (en) 2021-03-25

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