AU2018433575B2 - Stable, concentrated radionuclide complex solutions - Google Patents

Stable, concentrated radionuclide complex solutions Download PDF

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Publication number
AU2018433575B2
AU2018433575B2 AU2018433575A AU2018433575A AU2018433575B2 AU 2018433575 B2 AU2018433575 B2 AU 2018433575B2 AU 2018433575 A AU2018433575 A AU 2018433575A AU 2018433575 A AU2018433575 A AU 2018433575A AU 2018433575 B2 AU2018433575 B2 AU 2018433575B2
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Australia
Prior art keywords
stabilizer
aqueous solution
solution
pharmaceutical aqueous
concentration
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AU2018433575A
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English (en)
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AU2018433575A1 (en
Inventor
Donato BARBATO
Clementina BRAMBATI
Daniela Chicco
Francesco DE PALO
Lorenza Fugazza
Maurizio Mariani
Giovanni TESORIERE
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Advanced Accelerator Applications SA
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Advanced Accelerator Applications SA
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=63794577&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018433575(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/IB2018/055575 external-priority patent/WO2020021310A1/en
Priority claimed from US16/045,484 external-priority patent/US20200030465A1/en
Application filed by Advanced Accelerator Applications SA filed Critical Advanced Accelerator Applications SA
Publication of AU2018433575A1 publication Critical patent/AU2018433575A1/en
Priority to AU2022203683A priority Critical patent/AU2022203683B2/en
Publication of AU2018433575B2 publication Critical patent/AU2018433575B2/en
Application granted granted Critical
Priority to AU2024201217A priority patent/AU2024201217B2/en
Priority to AU2025202231A priority patent/AU2025202231A1/en
Priority to AU2025204901A priority patent/AU2025204901B2/en
Priority to AU2025220852A priority patent/AU2025220852B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61K51/12—Preparations 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
    • A61K51/121—Solutions, i.e. homogeneous liquid formulation
    • 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
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0478—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group complexes from non-cyclic ligands, e.g. EDTA, MAG3
    • A61K51/048—DTPA (diethylenetriamine tetraacetic acid)
    • 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
    • A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
    • A61K51/0482—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group chelates from cyclic ligands, e.g. DOTA
    • 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
    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
AU2018433575A 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions Active AU2018433575B2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2022203683A AU2022203683B2 (en) 2018-07-25 2022-05-30 Stable, concentrated radionuclide complex solutions
AU2024201217A AU2024201217B2 (en) 2018-07-25 2024-02-23 Stable, concentrated radionuclide complex solutions
AU2025202231A AU2025202231A1 (en) 2018-07-25 2025-03-27 Stable, concentrated radionuclide complex solutions
AU2025204901A AU2025204901B2 (en) 2018-07-25 2025-06-27 Stable, concentrated radionuclide complex solutions
AU2025220852A AU2025220852B2 (en) 2018-07-25 2025-08-22 Stable, concentrated radionuclide complex solutions

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US16/045,484 2018-07-25
US16/045,484 US20200030465A1 (en) 2018-07-25 2018-07-25 Stable, concentrated radionuclide complex solutions
PCT/IB2018/055575 WO2020021310A1 (en) 2018-07-25 2018-07-25 Stable, concentrated radionuclide complex solutions
AUPCT/IB2018/055575 2018-07-25
PCT/IB2018/057415 WO2020021322A1 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022203683A Division AU2022203683B2 (en) 2018-07-25 2022-05-30 Stable, concentrated radionuclide complex solutions

Publications (2)

Publication Number Publication Date
AU2018433575A1 AU2018433575A1 (en) 2021-02-11
AU2018433575B2 true AU2018433575B2 (en) 2022-07-07

Family

ID=63794577

Family Applications (6)

Application Number Title Priority Date Filing Date
AU2018433575A Active AU2018433575B2 (en) 2018-07-25 2018-09-25 Stable, concentrated radionuclide complex solutions
AU2022203683A Active AU2022203683B2 (en) 2018-07-25 2022-05-30 Stable, concentrated radionuclide complex solutions
AU2024201217A Active AU2024201217B2 (en) 2018-07-25 2024-02-23 Stable, concentrated radionuclide complex solutions
AU2025202231A Pending AU2025202231A1 (en) 2018-07-25 2025-03-27 Stable, concentrated radionuclide complex solutions
AU2025204901A Active AU2025204901B2 (en) 2018-07-25 2025-06-27 Stable, concentrated radionuclide complex solutions
AU2025220852A Active AU2025220852B2 (en) 2018-07-25 2025-08-22 Stable, concentrated radionuclide complex solutions

Family Applications After (5)

Application Number Title Priority Date Filing Date
AU2022203683A Active AU2022203683B2 (en) 2018-07-25 2022-05-30 Stable, concentrated radionuclide complex solutions
AU2024201217A Active AU2024201217B2 (en) 2018-07-25 2024-02-23 Stable, concentrated radionuclide complex solutions
AU2025202231A Pending AU2025202231A1 (en) 2018-07-25 2025-03-27 Stable, concentrated radionuclide complex solutions
AU2025204901A Active AU2025204901B2 (en) 2018-07-25 2025-06-27 Stable, concentrated radionuclide complex solutions
AU2025220852A Active AU2025220852B2 (en) 2018-07-25 2025-08-22 Stable, concentrated radionuclide complex solutions

Country Status (23)

Country Link
EP (7) EP4640241A3 (https=)
JP (3) JP7402218B2 (https=)
KR (4) KR102865113B1 (https=)
CN (5) CN120860271A (https=)
AU (6) AU2018433575B2 (https=)
BR (1) BR112021001148A2 (https=)
CA (1) CA3153630A1 (https=)
CO (1) CO2021000506A2 (https=)
DE (3) DE202018006567U1 (https=)
DK (6) DK4545101T3 (https=)
ES (4) ES3064434T3 (https=)
FI (6) FI4541379T3 (https=)
HR (6) HRP20260338T1 (https=)
HU (1) HUE072720T2 (https=)
IL (4) IL319541B2 (https=)
LT (6) LT4541381T (https=)
MX (2) MX2021000805A (https=)
PL (5) PL3826686T3 (https=)
PT (6) PT4541381T (https=)
RS (5) RS67667B1 (https=)
SG (1) SG11202100645XA (https=)
SI (5) SI4545101T1 (https=)
WO (1) WO2020021322A1 (https=)

Families Citing this family (7)

* 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
EP4442285A1 (en) * 2021-11-30 2024-10-09 Nihon Medi-Physics Co., Ltd. Stabilized radiopharmaceutical composition
US20260053959A1 (en) * 2022-02-04 2026-02-26 Advanced Accelerator Applications Methods for large scale synthesis of radionuclide complexes
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
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
CN116920129A (zh) * 2022-04-02 2023-10-24 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
US20260102526A1 (en) * 2024-06-27 2026-04-16 Curium Us Llc 177lutetium-dota-tate formulations

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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
WO2018081860A1 (en) * 2016-11-04 2018-05-11 Clarity Pharmaceuticals Pty Ltd Formulations for radiotherapy and diagnostic imaging

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EP0647450A1 (en) 1993-09-09 1995-04-12 BEHRINGWERKE Aktiengesellschaft Improved prodrugs for enzyme mediated activation
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WO2018081860A1 (en) * 2016-11-04 2018-05-11 Clarity Pharmaceuticals Pty Ltd Formulations for radiotherapy and diagnostic imaging

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ES3063402T3 (en) 2026-04-16
AU2025202231A1 (en) 2025-04-17
FI3826686T3 (fi) 2025-08-20
HRP20260237T1 (hr) 2026-04-10
DK4545101T3 (da) 2026-03-02
KR20240033296A (ko) 2024-03-12
IL319542A (en) 2025-05-01
LT4541381T (lt) 2026-03-25
PL3826686T3 (pl) 2025-09-22
IL319541B1 (en) 2025-09-01
IL319541A (en) 2025-05-01
LT3826686T (lt) 2025-08-25
JP2022501313A (ja) 2022-01-06
PT4545100T (pt) 2026-02-16
HRP20260100T1 (hr) 2026-04-10
KR102865113B1 (ko) 2025-09-26
IL313560B1 (en) 2025-07-01
MX2021000805A (es) 2021-05-12
LT4541380T (lt) 2026-03-10
PL4541379T3 (pl) 2026-03-23
IL280314A (en) 2021-03-25
LT4545101T (lt) 2026-03-10
CN112584875A (zh) 2021-03-30
AU2018433575A1 (en) 2021-02-11
WO2020021322A1 (en) 2020-01-30
KR20260030955A (ko) 2026-03-06
EP4545100B1 (en) 2025-12-10
RS67754B1 (sr) 2026-03-31
AU2025220852A1 (en) 2025-09-11
AU2025204901B2 (en) 2025-09-18
RS67667B1 (sr) 2026-02-27
PT4545101T (pt) 2026-02-24
FI4541379T3 (fi) 2026-02-17
BR112021001148A2 (pt) 2021-04-20
CN120860271A (zh) 2025-10-31
CA3153630A1 (en) 2020-01-30
IL313560A (en) 2024-08-01
AU2022203683A1 (en) 2022-06-16
EP4541380B1 (en) 2025-12-10
EP4541381A3 (en) 2025-07-23
FI4541381T3 (fi) 2026-04-01
HRP20260222T1 (hr) 2026-03-27
KR20210035855A (ko) 2021-04-01
EP4545101A3 (en) 2025-07-23
DE202018007006U1 (de) 2025-11-13
FI4545100T3 (fi) 2026-03-02
EP4541379A3 (en) 2025-07-23
AU2024201217A1 (en) 2024-03-14
SG11202100645XA (en) 2021-02-25
FI4545101T3 (fi) 2026-02-24
CN120860270A (zh) 2025-10-31
RS67034B1 (sr) 2025-08-29
SI3826686T1 (sl) 2025-09-30
PL4545100T3 (pl) 2026-03-30
SI4541379T1 (sl) 2026-03-31
DK4541379T3 (da) 2026-02-02
DE202018006567U1 (de) 2021-04-01
MX2025012060A (es) 2025-11-03
IL319541B2 (en) 2026-01-01
ES3064589T3 (en) 2026-04-27
AU2022203683B2 (en) 2023-12-21
JP7402218B2 (ja) 2023-12-20
EP4545100A2 (en) 2025-04-30
HRP20250912T1 (hr) 2025-09-26
ES3038413T3 (en) 2025-10-13
LT4541379T (lt) 2026-02-10
EP3826686B1 (en) 2025-05-21
FI4541380T3 (fi) 2026-03-02
AU2024201217B2 (en) 2025-02-27
EP4640241A2 (en) 2025-10-29
JP7796696B2 (ja) 2026-01-09
EP4541380A3 (en) 2025-07-23
HUE072720T2 (hu) 2025-12-28
SI4545100T1 (sl) 2026-03-31
HRP20260338T1 (hr) 2026-04-10
EP4541381B1 (en) 2026-02-04
KR102932818B1 (ko) 2026-03-03
JP2025111424A (ja) 2025-07-30
IL313560B2 (en) 2025-11-01
PT4541380T (pt) 2026-02-24
PL4545101T3 (pl) 2026-03-30
EP4541381A2 (en) 2025-04-23
AU2025204901A1 (en) 2025-07-17
PL4541380T3 (pl) 2026-03-30
KR102643582B1 (ko) 2024-03-05
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